Osteopenia, Postmenopausal
Conditions
Brief summary
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.
Interventions
DRUGRomosozumab
Administered by subcutaneous injection
DRUGPlacebo
Administered by subcutaneous injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females between 45 to 80 years of age * Postmenopausal females * Low bone mineral density, defined by bone mineral density (BMD) T-scores between -1.0 and -2.5, inclusive, for the lumbar spine \[L1-L4\] or total evaluable vertebrae \[if fewer than L1-L4\] or total hip) * 25-hydroxyvitamin D ≥ 20 ng/mL * Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
Exclusion criteria
* Osteoporosis defined by bone mineral density (BMD) T-scores \< -2.5 for the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4) or total hip * Diagnosed with any condition that would affect bone metabolism * Previous exposure to AMG 785
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 169 days | Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: Is there a reasonable possibility that the event may have been caused by the investigational product?' |
| Number of Participants Who Developed Antibodies to Romosozumab | Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169. | All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing. Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. | Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts) |
| Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169. | — |
| Accumulation Ratio (AR) for Romosozumab | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. | The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose. |
| Percent Change From Baseline in Bone Mineral Density of the Total Spine | Baseline and days 29, 85, 127, and 169 | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab. |
| Percent Change From Baseline in Bone Mineral Density at the Total Hip | Baseline and days 29, 85, 127, and 169 | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. |
| Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Baseline and days 29, 85, 127, and 169 | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. |
| Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Baseline and days 29, 85, 127, and 169 | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. |
| Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Baseline and days 29, 85, 127, and 169 | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. |
| Time to Maximum Observed Concentration (Tmax) of Romosozumab | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL. |
| Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 | — |
| Percent Change From Baseline in Osteocalcin | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 | — |
| Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 | — |
| Percent Change From Baseline in Serum C-telopeptide (sCTX) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 | — |
| Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 | — |
| Percent Change From Baseline in Sclerostin | Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169 | — |
| Change From Baseline in Ionized Calcium | Baseline and day 169 (or earlier for participants who discontinued before day 169) | — |
| Percent Change From Baseline in Bone Mineral Density of the Whole Body | Baseline and days 29, 85, 127, and 169 | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. |
| Maximum Observed Concentration (Cmax) of Romosozumab | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. | — |
Participant flow
Recruitment details
This study was conducted at 4 centers in the United States (US) from 14 November 2007 to 2 December 2008.
Pre-assignment details
Participants were enrolled into 1 of 6 cohorts. In each of cohorts 1 to 4, healthy postmenopausal women were randomized in a 3:1 ratio to receive romosozumab or placebo; In each of cohorts 5 and 6, healthy men were randomized in a 3:1 ratio to receive romosozumab or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). | 12 |
| Romosozumab 1 mg/kg Q2W in Women Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. | 6 |
| Romosozumab 2 mg/kg Q4W in Women Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. | 6 |
| Romosozumab 2 mg/kg Q2W in Women Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. | 6 |
| Romosozumab 3 mg/kg Q4W in Women Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. | 6 |
| Romosozumab 1 mg/kg Q2W in Men Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. | 6 |
| Romosozumab 3 mg/kg Q4W in Men Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. | 6 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 5.6 | 56.8 years STANDARD_DEVIATION 7.8 | 57.3 years STANDARD_DEVIATION 6.6 | 62.5 years STANDARD_DEVIATION 8 | 54.3 years STANDARD_DEVIATION 7.8 | 61.2 years STANDARD_DEVIATION 9 | 59.3 years STANDARD_DEVIATION 12.7 | 58.7 years STANDARD_DEVIATION 8 |
| Age, Customized 18 to 64 years | 11 Participants | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 4 Participants | 36 Participants |
| Age, Customized 65 to 74 years | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 10 Participants |
| Age, Customized ≥ 75 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 29 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 0 Participants | 0 Participants | 32 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 12 | 6 / 6 | 6 / 6 | 6 / 6 | 5 / 6 | 5 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 1 / 6 |
Outcome results
Primary
Number of Participants Who Developed Antibodies to Romosozumab
All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing. Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline.
Time frame: Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169.
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Developed Antibodies to Romosozumab | Binding antibodies | 0 Participants |
| Placebo | Number of Participants Who Developed Antibodies to Romosozumab | Neutralizing antibodies | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Binding antibodies | 2 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Neutralizing antibodies | 1 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Binding antibodies | 2 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Neutralizing antibodies | 1 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Binding antibodies | 2 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Neutralizing antibodies | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Binding antibodies | 3 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants Who Developed Antibodies to Romosozumab | Neutralizing antibodies | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants Who Developed Antibodies to Romosozumab | Binding antibodies | 1 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants Who Developed Antibodies to Romosozumab | Neutralizing antibodies | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants Who Developed Antibodies to Romosozumab | Binding antibodies | 3 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants Who Developed Antibodies to Romosozumab | Neutralizing antibodies | 1 Participants |
Primary
Number of Participants With Adverse Events
Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: Is there a reasonable possibility that the event may have been caused by the investigational product?'
Time frame: 169 days
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events | Death on study | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Any adverse event | 10 Participants |
| Placebo | Number of Participants With Adverse Events | Treatment-related adverse events | 6 Participants |
| Placebo | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants With Adverse Events | Any adverse event | 6 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants With Adverse Events | Death on study | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Women | Number of Participants With Adverse Events | Treatment-related adverse events | 1 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants With Adverse Events | Treatment-related adverse events | 1 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants With Adverse Events | Death on study | 0 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants With Adverse Events | Any adverse event | 6 Participants |
| Romosozumab 2 mg/kg Q4W in Women | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants With Adverse Events | Any adverse event | 6 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants With Adverse Events | Treatment-related adverse events | 4 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| Romosozumab 2 mg/kg Q2W in Women | Number of Participants With Adverse Events | Death on study | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants With Adverse Events | Serious adverse events | 1 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants With Adverse Events | Discontinuation due to adverse events | 1 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants With Adverse Events | Death on study | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants With Adverse Events | Treatment-related adverse events | 3 Participants |
| Romosozumab 3 mg/kg Q4W in Women | Number of Participants With Adverse Events | Any adverse event | 5 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants With Adverse Events | Treatment-related adverse events | 3 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants With Adverse Events | Any adverse event | 5 Participants |
| Romosozumab 1 mg/kg Q2W in Men | Number of Participants With Adverse Events | Death on study | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants With Adverse Events | Treatment-related adverse events | 2 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants With Adverse Events | Serious adverse events | 1 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants With Adverse Events | Death on study | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Romosozumab 3 mg/kg Q4W in Men | Number of Participants With Adverse Events | Any adverse event | 5 Participants |
Secondary
Accumulation Ratio (AR) for Romosozumab
The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose.
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Accumulation Ratio (AR) for Romosozumab | 2.15 ratio | Standard Deviation 0.45 |
| Romosozumab 1 mg/kg Q2W in Women | Accumulation Ratio (AR) for Romosozumab | 1.17 ratio | Standard Deviation 0.26 |
| Romosozumab 2 mg/kg Q4W in Women | Accumulation Ratio (AR) for Romosozumab | 2.35 ratio | Standard Deviation 0.9 |
| Romosozumab 2 mg/kg Q2W in Women | Accumulation Ratio (AR) for Romosozumab | 1.35 ratio | Standard Deviation 0.19 |
| Romosozumab 3 mg/kg Q4W in Women | Accumulation Ratio (AR) for Romosozumab | 1.90 ratio | Standard Deviation 0.49 |
| Romosozumab 1 mg/kg Q2W in Men | Accumulation Ratio (AR) for Romosozumab | 1.26 ratio | Standard Deviation 0.23 |
Secondary
Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab
Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts)
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | First dose | 65.5 μg*day/mL | Standard Deviation 15.6 |
| Placebo | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Last dose | 141 μg*day/mL | Standard Deviation 41 |
| Romosozumab 1 mg/kg Q2W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | First dose | 202 μg*day/mL | Standard Deviation 48 |
| Romosozumab 1 mg/kg Q2W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Last dose | 231 μg*day/mL | Standard Deviation 58 |
| Romosozumab 2 mg/kg Q4W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | First dose | 152 μg*day/mL | Standard Deviation 63 |
| Romosozumab 2 mg/kg Q4W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Last dose | 321 μg*day/mL | Standard Deviation 97 |
| Romosozumab 2 mg/kg Q2W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | First dose | 340 μg*day/mL | Standard Deviation 73 |
| Romosozumab 2 mg/kg Q2W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Last dose | 462 μg*day/mL | Standard Deviation 97 |
| Romosozumab 3 mg/kg Q4W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | First dose | 71.3 μg*day/mL | Standard Deviation 11.8 |
| Romosozumab 3 mg/kg Q4W in Women | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Last dose | 136 μg*day/mL | Standard Deviation 42 |
| Romosozumab 1 mg/kg Q2W in Men | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | First dose | 434 μg*day/mL | Standard Deviation 81 |
| Romosozumab 1 mg/kg Q2W in Men | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Last dose | 555 μg*day/mL | Standard Deviation 181 |
Secondary
Change From Baseline in Ionized Calcium
Time frame: Baseline and day 169 (or earlier for participants who discontinued before day 169)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Ionized Calcium | 0.05 mg/dL | Standard Deviation 0.17 |
| Romosozumab 1 mg/kg Q2W in Women | Change From Baseline in Ionized Calcium | 0.12 mg/dL | Standard Deviation 0.1 |
| Romosozumab 2 mg/kg Q4W in Women | Change From Baseline in Ionized Calcium | 0.06 mg/dL | Standard Deviation 0.21 |
| Romosozumab 2 mg/kg Q2W in Women | Change From Baseline in Ionized Calcium | -0.07 mg/dL | Standard Deviation 0.18 |
| Romosozumab 3 mg/kg Q4W in Women | Change From Baseline in Ionized Calcium | -0.05 mg/dL | Standard Deviation 0.04 |
| Romosozumab 1 mg/kg Q2W in Men | Change From Baseline in Ionized Calcium | -0.14 mg/dL | Standard Deviation 0.18 |
| Romosozumab 3 mg/kg Q4W in Men | Change From Baseline in Ionized Calcium | -0.06 mg/dL | Standard Deviation 0.14 |
Secondary
Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab
Time frame: Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169.
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | 7.02 days | Standard Deviation 3.52 |
| Romosozumab 1 mg/kg Q2W in Women | Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | 6.51 days | Standard Deviation 1.37 |
| Romosozumab 2 mg/kg Q4W in Women | Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | 9.32 days | Standard Deviation 1.88 |
| Romosozumab 2 mg/kg Q2W in Women | Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | 6.84 days | Standard Deviation 1.79 |
| Romosozumab 3 mg/kg Q4W in Women | Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | 6.77 days | Standard Deviation 1.92 |
| Romosozumab 1 mg/kg Q2W in Men | Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | 6.07 days | Standard Deviation 1.5 |
Secondary
Maximum Observed Concentration (Cmax) of Romosozumab
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Observed Concentration (Cmax) of Romosozumab | First dose | 6.80 μg/mL | Standard Deviation 1.86 |
| Placebo | Maximum Observed Concentration (Cmax) of Romosozumab | Last dose | 14.2 μg/mL | Standard Deviation 4.3 |
| Romosozumab 1 mg/kg Q2W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | First dose | 15.7 μg/mL | Standard Deviation 4.6 |
| Romosozumab 1 mg/kg Q2W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | Last dose | 16.7 μg/mL | Standard Deviation 3.3 |
| Romosozumab 2 mg/kg Q4W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | First dose | 14.8 μg/mL | Standard Deviation 6 |
| Romosozumab 2 mg/kg Q4W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | Last dose | 27.8 μg/mL | Standard Deviation 8.4 |
| Romosozumab 2 mg/kg Q2W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | First dose | 24.5 μg/mL | Standard Deviation 6.8 |
| Romosozumab 2 mg/kg Q2W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | Last dose | 29.5 μg/mL | Standard Deviation 8.7 |
| Romosozumab 3 mg/kg Q4W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | First dose | 8.06 μg/mL | Standard Deviation 1.57 |
| Romosozumab 3 mg/kg Q4W in Women | Maximum Observed Concentration (Cmax) of Romosozumab | Last dose | 13.4 μg/mL | Standard Deviation 4.4 |
| Romosozumab 1 mg/kg Q2W in Men | Maximum Observed Concentration (Cmax) of Romosozumab | First dose | 27.7 μg/mL | Standard Deviation 4.2 |
| Romosozumab 1 mg/kg Q2W in Men | Maximum Observed Concentration (Cmax) of Romosozumab | Last dose | 37.1 μg/mL | Standard Deviation 8.1 |
Secondary
Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Population: Treated participants with available data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 29 | 1.676 percent change | Standard Error 0.897 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 85 | 0.609 percent change | Standard Error 0.943 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 127 | 0.835 percent change | Standard Error 0.988 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 169 | -0.191 percent change | Standard Error 0.753 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 169 | 0.522 percent change | Standard Error 1.835 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 127 | 0.680 percent change | Standard Error 1.345 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 29 | -0.220 percent change | Standard Error 0.998 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 85 | -0.082 percent change | Standard Error 1.012 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 127 | -1.037 percent change | Standard Error 0.668 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 85 | -2.740 percent change | Standard Error 0.77 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 29 | -0.900 percent change | Standard Error 0.733 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 169 | 0.240 percent change | Standard Error 1.068 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 29 | -2.052 percent change | Standard Error 1.295 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 85 | 0.803 percent change | Standard Error 1.411 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 127 | 0.633 percent change | Standard Error 1.45 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 169 | -0.028 percent change | Standard Error 1.943 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 29 | -2.968 percent change | Standard Error 0.93 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 169 | -3.647 percent change | Standard Error 0.924 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 85 | -4.125 percent change | Standard Error 0.421 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 127 | -4.739 percent change | Standard Error 0.642 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 85 | -2.504 percent change | Standard Error 1.777 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 29 | -0.435 percent change | Standard Error 1.078 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 127 | -1.756 percent change | Standard Error 1.158 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 169 | -1.836 percent change | Standard Error 1.145 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 127 | -2.263 percent change | Standard Error 1.227 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 29 | -1.185 percent change | Standard Error 1.101 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 85 | -0.993 percent change | Standard Error 1.478 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Day 169 | -1.449 percent change | Standard Error 1.106 |
Secondary
Percent Change From Baseline in Bone Mineral Density at the Femoral Hip
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Population: Treated participants with available data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 29 | -0.394 percent change | Standard Error 0.573 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 85 | -1.175 percent change | Standard Error 1.042 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 127 | -2.301 percent change | Standard Error 0.745 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 169 | -0.447 percent change | Standard Error 0.673 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 169 | 0.801 percent change | Standard Error 1.208 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 127 | 1.284 percent change | Standard Error 1.255 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 29 | 0.300 percent change | Standard Error 0.813 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 85 | 1.360 percent change | Standard Error 1.031 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 127 | -1.005 percent change | Standard Error 2.609 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 85 | 0.578 percent change | Standard Error 1.285 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 29 | -2.172 percent change | Standard Error 1.331 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 169 | -0.672 percent change | Standard Error 1.783 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 29 | -0.811 percent change | Standard Error 1.596 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 85 | -0.123 percent change | Standard Error 1.001 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 127 | 1.471 percent change | Standard Error 1.228 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 169 | 0.510 percent change | Standard Error 1.103 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 29 | -0.473 percent change | Standard Error 1.987 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 169 | 2.197 percent change | Standard Error 1.674 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 85 | 0.270 percent change | Standard Error 1.176 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 127 | 1.332 percent change | Standard Error 2.488 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 85 | 1.301 percent change | Standard Error 0.681 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 29 | 0.471 percent change | Standard Error 1.919 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 127 | 1.861 percent change | Standard Error 1.208 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 169 | 1.665 percent change | Standard Error 1.582 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 127 | 0.091 percent change | Standard Error 1.11 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 29 | -0.597 percent change | Standard Error 0.839 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 85 | 1.956 percent change | Standard Error 1.493 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Day 169 | 0.116 percent change | Standard Error 2.003 |
Secondary
Percent Change From Baseline in Bone Mineral Density at the Total Hip
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Population: Treated participants with available data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 29 | -0.552 percent change | Standard Error 0.347 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 85 | -0.613 percent change | Standard Error 0.529 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 127 | -0.793 percent change | Standard Error 0.623 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 169 | -0.511 percent change | Standard Error 0.38 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 169 | 1.423 percent change | Standard Error 1.047 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 127 | 0.702 percent change | Standard Error 1.18 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 29 | 0.528 percent change | Standard Error 0.617 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 85 | 1.066 percent change | Standard Error 0.938 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 127 | 0.621 percent change | Standard Error 0.94 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 85 | 0.639 percent change | Standard Error 0.608 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 29 | -0.768 percent change | Standard Error 0.334 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 169 | 0.894 percent change | Standard Error 1.013 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 29 | 0.112 percent change | Standard Error 0.94 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 85 | 2.116 percent change | Standard Error 0.477 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 127 | 2.855 percent change | Standard Error 0.778 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 169 | 3.176 percent change | Standard Error 1.105 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 29 | -0.318 percent change | Standard Error 1.182 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 169 | 2.094 percent change | Standard Error 0.751 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 85 | 2.088 percent change | Standard Error 0.55 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 127 | 3.996 percent change | Standard Error 1.109 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 85 | 1.134 percent change | Standard Error 0.797 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 29 | 1.244 percent change | Standard Error 1.368 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 127 | 2.111 percent change | Standard Error 0.486 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 169 | 1.007 percent change | Standard Error 0.422 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 127 | 1.455 percent change | Standard Error 0.669 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 29 | -0.902 percent change | Standard Error 0.408 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 85 | 0.731 percent change | Standard Error 0.621 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Day 169 | 0.370 percent change | Standard Error 0.629 |
Secondary
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Population: Treated participants with available data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | 0.135 percent change | Standard Error 0.529 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | 0.329 percent change | Standard Error 0.604 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | 0.236 percent change | Standard Error 0.563 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | 0.417 percent change | Standard Error 0.768 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | -1.102 percent change | Standard Error 1.834 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | -1.134 percent change | Standard Error 1.388 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | -0.552 percent change | Standard Error 1.134 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | -0.063 percent change | Standard Error 1.269 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | 0.493 percent change | Standard Error 0.792 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | -0.754 percent change | Standard Error 0.533 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | -0.014 percent change | Standard Error 0.591 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | -0.928 percent change | Standard Error 0.717 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | -0.020 percent change | Standard Error 0.944 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | 0.448 percent change | Standard Error 0.549 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | -0.739 percent change | Standard Error 0.595 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | -0.234 percent change | Standard Error 1.126 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | -0.438 percent change | Standard Error 1.054 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | -2.632 percent change | Standard Error 1.466 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | -3.621 percent change | Standard Error 1.424 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | -3.326 percent change | Standard Error 1.895 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | -0.306 percent change | Standard Error 0.51 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | 0.757 percent change | Standard Error 0.698 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | -0.914 percent change | Standard Error 0.338 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | -0.378 percent change | Standard Error 0.818 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | -1.019 percent change | Standard Error 0.647 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | 0.021 percent change | Standard Error 0.479 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | 0.160 percent change | Standard Error 0.296 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | -0.211 percent change | Standard Error 0.619 |
Secondary
Percent Change From Baseline in Bone Mineral Density of the Total Spine
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Population: Treated participants with available data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 29 | -0.046 percent change | Standard Error 0.778 |
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 85 | -0.843 percent change | Standard Error 0.829 |
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 127 | 0.177 percent change | Standard Error 0.907 |
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 169 | -0.559 percent change | Standard Error 1.013 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 169 | 4.769 percent change | Standard Error 1.916 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 127 | 4.313 percent change | Standard Error 3.057 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 29 | 2.161 percent change | Standard Error 0.177 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 85 | 3.579 percent change | Standard Error 1.942 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 127 | 7.219 percent change | Standard Error 1.243 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 85 | 3.881 percent change | Standard Error 1.437 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 29 | 0.541 percent change | Standard Error 1.296 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 169 | 4.835 percent change | Standard Error 1.116 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 29 | -0.495 percent change | Standard Error 0.93 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 85 | 3.853 percent change | Standard Error 0.543 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 127 | 6.350 percent change | Standard Error 0.732 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 169 | 5.250 percent change | Standard Error 1.63 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 29 | -0.257 percent change | Standard Error 0.623 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 169 | 4.980 percent change | Standard Error 2.111 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 85 | 3.146 percent change | Standard Error 2.027 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 127 | 5.566 percent change | Standard Error 2.142 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 85 | 3.135 percent change | Standard Error 1.085 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 29 | 2.662 percent change | Standard Error 0.804 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 127 | 4.462 percent change | Standard Error 1.787 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 169 | 5.187 percent change | Standard Error 0.825 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 127 | 5.599 percent change | Standard Error 0.756 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 29 | -0.660 percent change | Standard Error 1.24 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 85 | 4.157 percent change | Standard Error 0.714 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Day 169 | 6.560 percent change | Standard Error 1.293 |
Secondary
Percent Change From Baseline in Bone Mineral Density of the Whole Body
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Population: Treated participants with available data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 29 | -0.391 percent change | Standard Error 0.347 |
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 85 | 0.103 percent change | Standard Error 0.391 |
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 127 | 0.000 percent change | Standard Error 0.371 |
| Placebo | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 169 | -0.352 percent change | Standard Error 0.32 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 169 | 0.180 percent change | Standard Error 1.143 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 127 | -1.068 percent change | Standard Error 0.357 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 29 | 0.493 percent change | Standard Error 0.58 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 85 | 0.259 percent change | Standard Error 0.642 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 127 | -0.486 percent change | Standard Error 0.938 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 85 | -0.324 percent change | Standard Error 0.827 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 29 | -1.122 percent change | Standard Error 0.885 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 169 | -0.294 percent change | Standard Error 0.597 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 29 | -0.532 percent change | Standard Error 0.188 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 85 | 1.359 percent change | Standard Error 0.276 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 127 | 1.442 percent change | Standard Error 0.862 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 169 | 1.284 percent change | Standard Error 0.637 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 29 | 0.521 percent change | Standard Error 0.567 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 169 | 0.801 percent change | Standard Error 0.523 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 85 | -0.151 percent change | Standard Error 0.614 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 127 | 0.513 percent change | Standard Error 0.6 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 85 | 0.459 percent change | Standard Error 0.271 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 29 | -0.058 percent change | Standard Error 0.387 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 127 | 1.919 percent change | Standard Error 0.839 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 169 | 1.285 percent change | Standard Error 0.264 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 127 | 0.012 percent change | Standard Error 0.562 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 29 | -0.611 percent change | Standard Error 0.344 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 85 | 0.243 percent change | Standard Error 0.447 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Day 169 | 0.218 percent change | Standard Error 0.819 |
Secondary
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 169 | 3.90 percent change | Standard Error 5.22 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 15 | -3.26 percent change | Standard Error 3.45 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 99 | -3.35 percent change | Standard Error 4.67 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 43 | -1.93 percent change | Standard Error 5.02 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 141 | 2.55 percent change | Standard Error 5.44 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 36 | 0.04 percent change | Standard Error 3.62 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 4 | 2.16 percent change | Standard Error 3.11 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 29 | -2.04 percent change | Standard Error 2.94 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 22 | 1.23 percent change | Standard Error 3.14 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 64 | -8.42 percent change | Standard Error 5.15 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 155 | 5.25 percent change | Standard Error 5.28 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 113 | 7.31 percent change | Standard Error 6.57 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 74 | -11.97 percent change | Standard Error 7.31 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 2 | -0.07 percent change | Standard Error 2.8 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 72 | -7.83 percent change | Standard Error 3.96 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 85 | -1.70 percent change | Standard Error 3.61 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 62 | -8.41 percent change | Standard Error 5.03 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 76 | -9.30 percent change | Standard Error 5.16 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 60 | -7.26 percent change | Standard Error 5.69 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 58 | -2.79 percent change | Standard Error 8.79 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 127 | 0.52 percent change | Standard Error 5.26 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 8 | -3.30 percent change | Standard Error 5.72 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 6 | 2.26 percent change | Standard Error 3.85 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 57 | -2.15 percent change | Standard Error 5.99 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 50 | -5.81 percent change | Standard Error 4.23 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 71 | -8.14 percent change | Standard Error 4.26 |
| Placebo | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 78 | -3.54 percent change | Standard Error 4.26 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 99 | 23.36 percent change | Standard Error 10.68 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 72 | 32.18 percent change | Standard Error 12.27 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 74 | 20.46 percent change | Standard Error 15.03 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 78 | 33.07 percent change | Standard Error 12.2 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 6 | 11.82 percent change | Standard Error 7.95 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 85 | 26.01 percent change | Standard Error 12.18 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 8 | 20.02 percent change | Standard Error 10.24 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 2 | -4.51 percent change | Standard Error 3.09 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 169 | -1.37 percent change | Standard Error 6.27 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 15 | 31.67 percent change | Standard Error 14.36 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 22 | 39.83 percent change | Standard Error 11.04 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 76 | 40.67 percent change | Standard Error 12.44 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 155 | -0.82 percent change | Standard Error 6.82 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 29 | 56.09 percent change | Standard Error 19.29 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 36 | 54.87 percent change | Standard Error 14.4 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 4 | -2.74 percent change | Standard Error 4.96 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 141 | -1.68 percent change | Standard Error 6.67 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 43 | 49.26 percent change | Standard Error 14.03 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 50 | 45.38 percent change | Standard Error 15.81 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 127 | -2.73 percent change | Standard Error 7.12 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 57 | 41.39 percent change | Standard Error 11.28 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 113 | 10.26 percent change | Standard Error 9.51 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 64 | 34.60 percent change | Standard Error 12.41 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 71 | 34.29 percent change | Standard Error 11.32 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 78 | 19.74 percent change | Standard Error 6.38 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 15 | 31.96 percent change | Standard Error 6.28 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 43 | 39.33 percent change | Standard Error 10.46 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 4 | -4.52 percent change | Standard Error 7.52 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 127 | -2.30 percent change | Standard Error 4.12 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 99 | -1.91 percent change | Standard Error 3.22 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 8 | 9.69 percent change | Standard Error 4.75 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 57 | 38.07 percent change | Standard Error 11.16 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 169 | -5.72 percent change | Standard Error 5.75 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 58 | 29.12 percent change | Standard Error 12.18 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 2 | -8.52 percent change | Standard Error 3.73 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 113 | -3.15 percent change | Standard Error 3.85 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 60 | 18.64 percent change | Standard Error 9.41 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 71 | 16.29 percent change | Standard Error 6.39 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 6 | 7.76 percent change | Standard Error 3.93 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 62 | 24.58 percent change | Standard Error 10.61 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 85 | 7.70 percent change | Standard Error 5.59 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 36 | 28.89 percent change | Standard Error 7.65 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 22 | 37.30 percent change | Standard Error 4.15 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 155 | -4.10 percent change | Standard Error 4.67 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 29 | 36.50 percent change | Standard Error 8.85 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 141 | -5.98 percent change | Standard Error 5.03 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 64 | 19.54 percent change | Standard Error 5.71 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 169 | 2.33 percent change | Standard Error 4.19 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 76 | 51.82 percent change | Standard Error 9.53 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 36 | 72.39 percent change | Standard Error 12.18 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 64 | 77.50 percent change | Standard Error 10.29 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 72 | 50.19 percent change | Standard Error 10.57 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 15 | 33.68 percent change | Standard Error 8.61 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 22 | 58.45 percent change | Standard Error 14.4 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 99 | 24.89 percent change | Standard Error 14.52 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 78 | 64.46 percent change | Standard Error 11.16 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 43 | 68.54 percent change | Standard Error 12.84 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 2 | 10.25 percent change | Standard Error 3.5 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 127 | 9.62 percent change | Standard Error 6.27 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 29 | 65.10 percent change | Standard Error 14.72 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 8 | 21.51 percent change | Standard Error 6.34 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 6 | 14.17 percent change | Standard Error 2.52 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 50 | 68.67 percent change | Standard Error 11 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 85 | 69.90 percent change | Standard Error 21.35 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 155 | 6.15 percent change | Standard Error 4.92 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 74 | 57.85 percent change | Standard Error 10.91 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 141 | 2.90 percent change | Standard Error 7.1 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 57 | 65.28 percent change | Standard Error 9.34 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 4 | 13.74 percent change | Standard Error 3.39 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 71 | 52.77 percent change | Standard Error 7.72 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 113 | 14.75 percent change | Standard Error 5.08 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 62 | 38.52 percent change | Standard Error 7.59 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 2 | 2.22 percent change | Standard Error 4.04 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 4 | 1.15 percent change | Standard Error 6.14 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 6 | 12.59 percent change | Standard Error 4.56 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 8 | 21.87 percent change | Standard Error 9.57 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 15 | 51.97 percent change | Standard Error 5.28 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 22 | 57.66 percent change | Standard Error 9.91 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 29 | 61.66 percent change | Standard Error 13.21 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 36 | 63.55 percent change | Standard Error 10.27 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 43 | 66.74 percent change | Standard Error 10.38 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 57 | 47.38 percent change | Standard Error 6.06 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 58 | 39.33 percent change | Standard Error 5.29 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 60 | 38.07 percent change | Standard Error 7.47 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 64 | 38.38 percent change | Standard Error 7.43 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 71 | 44.72 percent change | Standard Error 9.3 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 78 | 43.30 percent change | Standard Error 14.16 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 85 | 38.27 percent change | Standard Error 4.2 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 99 | 5.10 percent change | Standard Error 1.62 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 113 | -5.26 percent change | Standard Error 10.2 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 127 | 1.13 percent change | Standard Error 6.36 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 141 | 3.75 percent change | Standard Error 3.96 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 155 | 5.12 percent change | Standard Error 6.77 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 169 | 16.26 percent change | Standard Error 7.56 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 71 | 25.46 percent change | Standard Error 15.12 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 64 | 27.78 percent change | Standard Error 13.26 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 99 | 17.55 percent change | Standard Error 17.51 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 72 | 19.60 percent change | Standard Error 10.46 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 113 | -6.58 percent change | Standard Error 3.92 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 57 | 38.47 percent change | Standard Error 12.18 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 50 | 34.97 percent change | Standard Error 10.37 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 43 | 27.55 percent change | Standard Error 8.68 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 74 | 15.07 percent change | Standard Error 13.92 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 127 | -6.54 percent change | Standard Error 7.54 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 36 | 43.48 percent change | Standard Error 7.98 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 29 | 36.74 percent change | Standard Error 10.53 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 4 | 8.29 percent change | Standard Error 6.28 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 141 | -4.71 percent change | Standard Error 4.43 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 22 | 27.74 percent change | Standard Error 7.34 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 15 | 15.58 percent change | Standard Error 4.69 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 155 | -4.11 percent change | Standard Error 3.38 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 8 | 24.20 percent change | Standard Error 14.92 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 6 | 3.64 percent change | Standard Error 6.4 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 2 | 5.82 percent change | Standard Error 2.73 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 169 | -4.76 percent change | Standard Error 5.36 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 78 | 13.37 percent change | Standard Error 7.3 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 76 | 17.91 percent change | Standard Error 12.86 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 85 | 18.68 percent change | Standard Error 9.63 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 64 | 45.24 percent change | Standard Error 9.78 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 78 | 47.07 percent change | Standard Error 12.38 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 4 | 6.68 percent change | Standard Error 3.66 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 6 | 6.93 percent change | Standard Error 1.29 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 99 | 13.75 percent change | Standard Error 6.54 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 62 | 31.71 percent change | Standard Error 10.53 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 60 | 36.75 percent change | Standard Error 11.16 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 58 | 44.24 percent change | Standard Error 13.63 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 57 | 44.53 percent change | Standard Error 11.57 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 141 | 9.34 percent change | Standard Error 3.25 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 22 | 61.39 percent change | Standard Error 14.64 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 113 | 14.50 percent change | Standard Error 5.38 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 71 | 47.47 percent change | Standard Error 9.99 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 15 | 46.38 percent change | Standard Error 8.63 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 43 | 52.27 percent change | Standard Error 13.48 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 85 | 42.53 percent change | Standard Error 14.53 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 2 | -0.80 percent change | Standard Error 4.2 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 169 | -0.42 percent change | Standard Error 6.39 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 127 | 5.26 percent change | Standard Error 5.75 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 36 | 34.27 percent change | Standard Error 7.92 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 155 | 6.78 percent change | Standard Error 8.32 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 29 | 35.63 percent change | Standard Error 13.78 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Day 8 | 20.98 percent change | Standard Error 2.05 |
Secondary
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 58 | -10.21 percent change | Standard Error 7.73 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | -8.84 percent change | Standard Error 5.93 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 78 | -16.60 percent change | Standard Error 5.7 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 155 | -15.06 percent change | Standard Error 4.78 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 50 | -7.02 percent change | Standard Error 9.81 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 36 | -14.24 percent change | Standard Error 4.63 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | -9.95 percent change | Standard Error 7.25 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 4 | -18.14 percent change | Standard Error 2.42 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 22 | -9.12 percent change | Standard Error 4.45 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 127 | -12.50 percent change | Standard Error 5.08 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | -7.45 percent change | Standard Error 6.7 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 71 | -10.38 percent change | Standard Error 3.86 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 76 | -8.27 percent change | Standard Error 6.56 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | -13.17 percent change | Standard Error 6.57 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 74 | -9.74 percent change | Standard Error 6.73 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | -20.78 percent change | Standard Error 5.77 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 64 | -6.40 percent change | Standard Error 8.29 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | -16.41 percent change | Standard Error 3.26 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 62 | -2.33 percent change | Standard Error 10.3 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 6 | -22.64 percent change | Standard Error 5.59 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | -7.05 percent change | Standard Error 7.87 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | -22.84 percent change | Standard Error 5.19 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 72 | -19.26 percent change | Standard Error 8.34 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 60 | -8.41 percent change | Standard Error 9.17 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | -5.72 percent change | Standard Error 4.12 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | -3.49 percent change | Standard Error 5.98 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 43 | -14.84 percent change | Standard Error 5.36 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 127 | -16.74 percent change | Standard Error 7.08 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 78 | 21.00 percent change | Standard Error 14.55 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 16.48 percent change | Standard Error 11.9 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 6 | -2.67 percent change | Standard Error 8.79 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 20.49 percent change | Standard Error 13.44 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 50 | 30.25 percent change | Standard Error 19.47 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 43 | 28.17 percent change | Standard Error 11.49 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | -0.20 percent change | Standard Error 6.59 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | -13.34 percent change | Standard Error 6.82 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 7.31 percent change | Standard Error 12.26 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 22 | 63.58 percent change | Standard Error 41.8 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 66.13 percent change | Standard Error 35.48 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | -18.84 percent change | Standard Error 7.75 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 26.13 percent change | Standard Error 14.71 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 36 | 25.21 percent change | Standard Error 11.9 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 4 | 0.35 percent change | Standard Error 13.61 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 155 | 1.27 percent change | Standard Error 8.24 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | -5.85 percent change | Standard Error 9.79 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 64 | 19.81 percent change | Standard Error 11.29 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 71 | 21.65 percent change | Standard Error 17.69 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 0.16 percent change | Standard Error 12.53 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 72 | 32.07 percent change | Standard Error 19.22 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 74 | 32.25 percent change | Standard Error 25.26 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 76 | 32.24 percent change | Standard Error 14.18 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 64 | 62.54 percent change | Standard Error 17.33 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | -8.33 percent change | Standard Error 8.3 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 14.08 percent change | Standard Error 7.81 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 16.68 percent change | Standard Error 13.79 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 127 | 3.14 percent change | Standard Error 14.76 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 60 | 52.00 percent change | Standard Error 20.18 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 155 | 10.09 percent change | Standard Error 11.69 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 71 | 40.97 percent change | Standard Error 15.06 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 4 | 18.59 percent change | Standard Error 17.92 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 58 | 34.80 percent change | Standard Error 16.82 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 62 | 48.83 percent change | Standard Error 20.01 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 13.91 percent change | Standard Error 11.95 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | -10.08 percent change | Standard Error 13.08 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 47.95 percent change | Standard Error 9.94 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 22 | 28.93 percent change | Standard Error 15.69 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | -2.09 percent change | Standard Error 12.69 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 41.90 percent change | Standard Error 10.87 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 18.72 percent change | Standard Error 12.98 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 6 | 23.15 percent change | Standard Error 15.52 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 36 | 57.32 percent change | Standard Error 15.99 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 43 | 47.38 percent change | Standard Error 19.72 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 31.59 percent change | Standard Error 25.03 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 78 | 44.03 percent change | Standard Error 11.32 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 155 | -15.78 percent change | Standard Error 7.72 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 76 | 2.58 percent change | Standard Error 14.33 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 43 | 23.77 percent change | Standard Error 26.38 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 72 | 41.99 percent change | Standard Error 35.57 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | -5.87 percent change | Standard Error 11.21 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | -10.00 percent change | Standard Error 7.92 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 26.12 percent change | Standard Error 20.92 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | -19.91 percent change | Standard Error 6.71 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 36 | 22.33 percent change | Standard Error 25.29 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | -7.82 percent change | Standard Error 8.93 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 4 | 2.94 percent change | Standard Error 19.63 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 78 | 31.00 percent change | Standard Error 22.68 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 7.94 percent change | Standard Error 4.48 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 6 | 8.42 percent change | Standard Error 17.7 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 64 | 30.11 percent change | Standard Error 13.35 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 127 | -11.32 percent change | Standard Error 7.81 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | -3.99 percent change | Standard Error 13.52 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 74 | 21.37 percent change | Standard Error 17.25 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 71 | 7.80 percent change | Standard Error 17.5 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 50 | 34.06 percent change | Standard Error 31.75 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 22 | 0.65 percent change | Standard Error 17.49 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 5.91 percent change | Standard Error 26.94 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 34.10 percent change | Standard Error 25.51 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | -19.71 percent change | Standard Error 9 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 58 | 57.65 percent change | Standard Error 25.32 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | -1.06 percent change | Standard Error 5.09 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 4 | 1.34 percent change | Standard Error 10.38 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 6 | 43.89 percent change | Standard Error 18.45 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 12.58 percent change | Standard Error 13.18 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 67.27 percent change | Standard Error 35.74 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 22 | 69.17 percent change | Standard Error 22.48 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 41.45 percent change | Standard Error 17.6 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 43 | 73.55 percent change | Standard Error 22.75 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 26.23 percent change | Standard Error 13.73 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 60 | 72.18 percent change | Standard Error 16.59 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 62 | 47.94 percent change | Standard Error 18.36 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 64 | 62.07 percent change | Standard Error 18.54 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 71 | 68.44 percent change | Standard Error 26.27 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 78 | 56.98 percent change | Standard Error 25.29 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 24.90 percent change | Standard Error 19.86 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 12.34 percent change | Standard Error 11.46 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | -10.83 percent change | Standard Error 19.52 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 127 | -7.07 percent change | Standard Error 6.79 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | -4.19 percent change | Standard Error 6.92 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 155 | 17.62 percent change | Standard Error 9.94 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | 30.72 percent change | Standard Error 20.07 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 36 | 54.47 percent change | Standard Error 18.24 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 4 | -5.59 percent change | Standard Error 31.57 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 155 | -3.50 percent change | Standard Error 10.45 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 72 | 30.65 percent change | Standard Error 17.43 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 23.91 percent change | Standard Error 21.12 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 76 | 20.58 percent change | Standard Error 20.98 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 22 | 24.27 percent change | Standard Error 21.16 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 71 | 11.07 percent change | Standard Error 24.13 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 6 | 20.35 percent change | Standard Error 21.69 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | -3.01 percent change | Standard Error 10.49 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 64 | 49.59 percent change | Standard Error 26.25 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | -1.40 percent change | Standard Error 14.42 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 50 | 41.77 percent change | Standard Error 27.38 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 8.68 percent change | Standard Error 5.69 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 36 | 37.99 percent change | Standard Error 26.79 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | -16.85 percent change | Standard Error 13.53 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | -2.24 percent change | Standard Error 9.43 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 13.19 percent change | Standard Error 18.27 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 33.55 percent change | Standard Error 22.61 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 26.14 percent change | Standard Error 26.62 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 127 | -2.02 percent change | Standard Error 17.24 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 3.12 percent change | Standard Error 12.69 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 43 | 39.90 percent change | Standard Error 17.9 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 78 | 28.62 percent change | Standard Error 13.12 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 74 | 71.86 percent change | Standard Error 39.62 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 22 | 48.13 percent change | Standard Error 37.16 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 16.73 percent change | Standard Error 18.23 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 71 | 15.84 percent change | Standard Error 12.81 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 64 | 64.46 percent change | Standard Error 31.92 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 4 | -3.14 percent change | Standard Error 14.09 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 127 | 6.96 percent change | Standard Error 13.62 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 62 | 37.93 percent change | Standard Error 22.34 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 60 | 56.06 percent change | Standard Error 31.4 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 58 | 24.71 percent change | Standard Error 15.33 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 23.55 percent change | Standard Error 28.82 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | 10.80 percent change | Standard Error 18.12 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 43 | 37.55 percent change | Standard Error 31.09 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 3.68 percent change | Standard Error 19.02 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 155 | 8.76 percent change | Standard Error 16.71 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 12.46 percent change | Standard Error 27.05 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | -5.04 percent change | Standard Error 8.62 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | 15.09 percent change | Standard Error 21.69 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 9.33 percent change | Standard Error 24.92 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 36 | 10.94 percent change | Standard Error 14.7 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 29.25 percent change | Standard Error 25.49 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 78 | 22.73 percent change | Standard Error 27.28 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 6 | -4.22 percent change | Standard Error 11.74 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 2.69 percent change | Standard Error 19.1 |
Secondary
Percent Change From Baseline in Osteocalcin
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Osteocalcin | Day 15 | -0.15 percent change | Standard Error 2.34 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 99 | -4.97 percent change | Standard Error 3.94 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 78 | -3.86 percent change | Standard Error 3.35 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 60 | 0.77 percent change | Standard Error 5.59 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 8 | -3.68 percent change | Standard Error 3.16 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 155 | -3.51 percent change | Standard Error 4.78 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 2 | -0.19 percent change | Standard Error 2.81 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 169 | 1.25 percent change | Standard Error 5.3 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 50 | 0.92 percent change | Standard Error 5 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 22 | -4.19 percent change | Standard Error 2.06 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 29 | 0.02 percent change | Standard Error 2.67 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 36 | 3.54 percent change | Standard Error 2.61 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 57 | 4.07 percent change | Standard Error 2.05 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 6 | -4.74 percent change | Standard Error 2.91 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 58 | 7.56 percent change | Standard Error 5.24 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 85 | -4.37 percent change | Standard Error 3.11 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 141 | -3.80 percent change | Standard Error 3.25 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 76 | -4.13 percent change | Standard Error 7.92 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 113 | 2.57 percent change | Standard Error 4.85 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 127 | -0.34 percent change | Standard Error 4.46 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 64 | 6.99 percent change | Standard Error 4.49 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 72 | 5.04 percent change | Standard Error 5.29 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 4 | -3.07 percent change | Standard Error 2.54 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 74 | -5.91 percent change | Standard Error 2.36 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 62 | 14.12 percent change | Standard Error 3.88 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 71 | 1.87 percent change | Standard Error 3.02 |
| Placebo | Percent Change From Baseline in Osteocalcin | Day 43 | 1.20 percent change | Standard Error 2.85 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 6 | -5.55 percent change | Standard Error 6.37 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 72 | 32.17 percent change | Standard Error 9.97 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 113 | 4.81 percent change | Standard Error 8.41 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 8 | -7.13 percent change | Standard Error 3.83 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 85 | 41.36 percent change | Standard Error 11.92 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 15 | 23.55 percent change | Standard Error 10.75 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 141 | -2.99 percent change | Standard Error 8.22 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 78 | 29.10 percent change | Standard Error 8.42 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 127 | 2.79 percent change | Standard Error 13.64 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 29 | 49.44 percent change | Standard Error 16.03 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 4 | 1.17 percent change | Standard Error 6.38 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 169 | -7.12 percent change | Standard Error 7.84 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 43 | 45.46 percent change | Standard Error 12.44 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 99 | 21.81 percent change | Standard Error 7.95 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 36 | 48.91 percent change | Standard Error 10.93 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 50 | 48.63 percent change | Standard Error 13.2 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 57 | 49.28 percent change | Standard Error 10.45 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 76 | 36.41 percent change | Standard Error 9.63 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 22 | 29.99 percent change | Standard Error 8.26 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 155 | -6.23 percent change | Standard Error 7.52 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 64 | 27.01 percent change | Standard Error 9.96 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 2 | 6.61 percent change | Standard Error 2.18 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 71 | 39.49 percent change | Standard Error 12.97 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 74 | 31.72 percent change | Standard Error 10.55 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 60 | 3.28 percent change | Standard Error 11.15 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 22 | 34.90 percent change | Standard Error 16.55 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 155 | -21.04 percent change | Standard Error 7.35 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 4 | -13.51 percent change | Standard Error 1.88 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 62 | 2.04 percent change | Standard Error 9.84 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 113 | -11.70 percent change | Standard Error 6.94 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 8 | -4.14 percent change | Standard Error 6.29 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 169 | -20.27 percent change | Standard Error 8.66 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 2 | -7.02 percent change | Standard Error 4.56 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 64 | 0.57 percent change | Standard Error 10.33 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 127 | -13.58 percent change | Standard Error 4.48 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 78 | 12.60 percent change | Standard Error 11.1 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 6 | -14.09 percent change | Standard Error 5.65 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 15 | 21.18 percent change | Standard Error 6.94 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 141 | -25.33 percent change | Standard Error 10.05 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 85 | 19.11 percent change | Standard Error 9.44 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 71 | 27.96 percent change | Standard Error 11.89 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 36 | 35.29 percent change | Standard Error 9.36 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 57 | -0.80 percent change | Standard Error 15.19 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 58 | 8.12 percent change | Standard Error 11.58 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 29 | 39.52 percent change | Standard Error 11.33 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 99 | -9.45 percent change | Standard Error 6.47 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 43 | 30.75 percent change | Standard Error 14.39 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 6 | -0.71 percent change | Standard Error 6.79 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 85 | 63.71 percent change | Standard Error 11.99 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 127 | 24.45 percent change | Standard Error 15.36 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 99 | 49.49 percent change | Standard Error 16.14 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 113 | 31.46 percent change | Standard Error 10.14 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 4 | -21.97 percent change | Standard Error 5.5 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 43 | 77.15 percent change | Standard Error 14.86 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 50 | 89.23 percent change | Standard Error 18.31 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 57 | 70.82 percent change | Standard Error 16.48 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 29 | 81.71 percent change | Standard Error 19.2 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 155 | 7.69 percent change | Standard Error 8.01 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 64 | 60.91 percent change | Standard Error 11.91 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 71 | 81.01 percent change | Standard Error 20.69 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 141 | 21.63 percent change | Standard Error 8.86 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 8 | 22.82 percent change | Standard Error 5.24 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 36 | 76.70 percent change | Standard Error 12.51 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 15 | 33.18 percent change | Standard Error 9.05 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 2 | 4.95 percent change | Standard Error 4.34 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 72 | 95.28 percent change | Standard Error 20.14 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 169 | 16.81 percent change | Standard Error 12.43 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 22 | 57.55 percent change | Standard Error 11.24 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 74 | 60.58 percent change | Standard Error 13.97 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 76 | 49.94 percent change | Standard Error 3.93 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Osteocalcin | Day 78 | 74.99 percent change | Standard Error 13.37 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 6 | 11.34 percent change | Standard Error 6.43 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 141 | 17.25 percent change | Standard Error 9.58 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 71 | 77.51 percent change | Standard Error 7.93 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 64 | 70.63 percent change | Standard Error 10.99 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 62 | 67.70 percent change | Standard Error 12.26 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 60 | 61.68 percent change | Standard Error 9.37 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 99 | 31.98 percent change | Standard Error 6.31 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 22 | 84.14 percent change | Standard Error 12.09 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 127 | 152.92 percent change | Standard Error 144.3 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 58 | 75.01 percent change | Standard Error 14.15 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 155 | 6.85 percent change | Standard Error 14.51 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 57 | 74.73 percent change | Standard Error 8.81 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 2 | -4.09 percent change | Standard Error 6.71 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 43 | 90.14 percent change | Standard Error 17.06 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 4 | 6.66 percent change | Standard Error 6.63 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 36 | 87.21 percent change | Standard Error 16.45 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 113 | 20.24 percent change | Standard Error 15.41 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 15 | 70.19 percent change | Standard Error 15.1 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 8 | 41.85 percent change | Standard Error 29.46 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 29 | 90.08 percent change | Standard Error 7.79 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 169 | 24.60 percent change | Standard Error 12.75 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 85 | 77.23 percent change | Standard Error 16.82 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Osteocalcin | Day 78 | 85.53 percent change | Standard Error 15.09 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 8 | 17.92 percent change | Standard Error 8.35 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 22 | 61.18 percent change | Standard Error 19.45 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 29 | 55.58 percent change | Standard Error 10.4 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 2 | 9.53 percent change | Standard Error 3.94 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 36 | 35.55 percent change | Standard Error 12.53 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 43 | 57.62 percent change | Standard Error 13.39 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 50 | 52.53 percent change | Standard Error 19.49 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 57 | 69.16 percent change | Standard Error 19.15 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 64 | 50.40 percent change | Standard Error 22.63 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 4 | 9.13 percent change | Standard Error 17.95 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 6 | 16.14 percent change | Standard Error 13.24 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 71 | 51.69 percent change | Standard Error 16.41 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 15 | 45.22 percent change | Standard Error 13.53 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 72 | 63.00 percent change | Standard Error 13.12 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 74 | 52.83 percent change | Standard Error 12.14 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 76 | 60.11 percent change | Standard Error 16.94 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 78 | 56.10 percent change | Standard Error 19.3 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 85 | 48.66 percent change | Standard Error 12.49 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 99 | 33.70 percent change | Standard Error 18.41 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 113 | 12.25 percent change | Standard Error 12.11 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 127 | 5.06 percent change | Standard Error 14.88 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 141 | 8.58 percent change | Standard Error 9.2 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 155 | -7.10 percent change | Standard Error 10.56 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Osteocalcin | Day 169 | 2.19 percent change | Standard Error 10.84 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 29 | 79.45 percent change | Standard Error 17.12 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 127 | -3.88 percent change | Standard Error 11.3 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 15 | 24.73 percent change | Standard Error 5.35 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 71 | 79.70 percent change | Standard Error 19.98 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 8 | -2.77 percent change | Standard Error 4.06 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 6 | -2.00 percent change | Standard Error 3.09 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 4 | -9.27 percent change | Standard Error 2.61 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 22 | 64.18 percent change | Standard Error 10.17 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 141 | -4.33 percent change | Standard Error 7.28 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 64 | 68.64 percent change | Standard Error 16.9 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 62 | 47.72 percent change | Standard Error 17.8 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 60 | 57.90 percent change | Standard Error 19.58 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 58 | 75.70 percent change | Standard Error 20.03 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 57 | 81.16 percent change | Standard Error 16.26 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 169 | -13.66 percent change | Standard Error 10.56 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 155 | -11.15 percent change | Standard Error 14.79 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 43 | 82.02 percent change | Standard Error 14.92 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 36 | 68.03 percent change | Standard Error 8.81 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 2 | -4.69 percent change | Standard Error 5.12 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 113 | 6.17 percent change | Standard Error 10.83 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 99 | 30.28 percent change | Standard Error 26.45 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 85 | 81.93 percent change | Standard Error 31.34 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Osteocalcin | Day 78 | 89.23 percent change | Standard Error 23.86 |
Secondary
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | -0.36 percent change | Standard Error 5.54 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 12.70 percent change | Standard Error 12.29 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 62 | 5.62 percent change | Standard Error 2.62 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 58 | 12.47 percent change | Standard Error 6.76 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 50 | -12.20 percent change | Standard Error 5.65 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 7.58 percent change | Standard Error 7.52 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 6 | -5.99 percent change | Standard Error 4.33 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 155 | 5.71 percent change | Standard Error 4.91 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 141 | 4.35 percent change | Standard Error 4.72 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | -1.65 percent change | Standard Error 5.47 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | 3.39 percent change | Standard Error 5.36 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | 5.21 percent change | Standard Error 6.81 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | -1.01 percent change | Standard Error 4.04 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | -0.87 percent change | Standard Error 6.06 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 60 | 3.74 percent change | Standard Error 5.8 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 22 | 0.20 percent change | Standard Error 5.41 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 2 | -4.55 percent change | Standard Error 3.83 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | -2.40 percent change | Standard Error 3.78 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 72 | -2.97 percent change | Standard Error 4.13 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 36 | 5.42 percent change | Standard Error 5.56 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 0.81 percent change | Standard Error 3.92 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 78 | 2.61 percent change | Standard Error 5.24 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 76 | -5.50 percent change | Standard Error 6.48 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 43 | 2.97 percent change | Standard Error 5.73 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 74 | -11.52 percent change | Standard Error 6.52 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 0.11 percent change | Standard Error 2.87 |
| Placebo | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 1.74 percent change | Standard Error 5.2 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 51.25 percent change | Standard Error 15.27 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 78 | 51.59 percent change | Standard Error 18.64 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 49.88 percent change | Standard Error 14.11 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | 3.21 percent change | Standard Error 8.94 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 51.66 percent change | Standard Error 20.71 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 2 | 5.90 percent change | Standard Error 4.97 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 14.72 percent change | Standard Error 5.61 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 74 | 49.16 percent change | Standard Error 15.59 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 58.03 percent change | Standard Error 11.52 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 36 | 78.03 percent change | Standard Error 21.98 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 81.45 percent change | Standard Error 20.35 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 4.79 percent change | Standard Error 7.31 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 72 | 32.99 percent change | Standard Error 14.43 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 22 | 82.97 percent change | Standard Error 21.49 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 6 | 46.69 percent change | Standard Error 7.59 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | 5.15 percent change | Standard Error 8.34 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 155 | -5.45 percent change | Standard Error 6.57 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 50 | 73.72 percent change | Standard Error 23.57 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 141 | -5.75 percent change | Standard Error 5.62 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 43 | 69.94 percent change | Standard Error 20.47 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 35.64 percent change | Standard Error 11.54 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 45.25 percent change | Standard Error 8.02 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 76 | 45.95 percent change | Standard Error 18.18 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | -3.26 percent change | Standard Error 6.94 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | -3.90 percent change | Standard Error 10.1 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 2 | 4.37 percent change | Standard Error 3.98 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 16.32 percent change | Standard Error 6.77 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 6 | 32.85 percent change | Standard Error 7.41 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 37.14 percent change | Standard Error 11.6 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 66.12 percent change | Standard Error 14.63 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 22 | 53.76 percent change | Standard Error 19.99 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 36 | 59.50 percent change | Standard Error 21.56 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 43 | 62.16 percent change | Standard Error 23.95 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 3.28 percent change | Standard Error 10.72 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 58 | -7.77 percent change | Standard Error 9.58 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 62 | 11.85 percent change | Standard Error 9.79 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 10.92 percent change | Standard Error 11.34 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 20.01 percent change | Standard Error 13.17 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 78 | 1.29 percent change | Standard Error 11.31 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | -16.47 percent change | Standard Error 8.68 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -14.06 percent change | Standard Error 8.68 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | -8.76 percent change | Standard Error 9.73 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 141 | -19.84 percent change | Standard Error 7.87 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 155 | -19.92 percent change | Standard Error 9.17 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | -16.91 percent change | Standard Error 7.34 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 26.35 percent change | Standard Error 10.41 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 60 | 0.47 percent change | Standard Error 5.66 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 74 | 89.11 percent change | Standard Error 15.49 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | -9.51 percent change | Standard Error 10.1 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 43 | 93.15 percent change | Standard Error 20.34 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 76.66 percent change | Standard Error 21.28 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 141 | 2.88 percent change | Standard Error 10.84 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 2 | 1.18 percent change | Standard Error 4.35 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 6 | 23.19 percent change | Standard Error 10.4 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 95.15 percent change | Standard Error 21.45 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 155 | -0.73 percent change | Standard Error 8.7 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 88.47 percent change | Standard Error 15.08 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 1.42 percent change | Standard Error 6.81 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 76 | 100.22 percent change | Standard Error 18.29 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 36 | 140.47 percent change | Standard Error 17.7 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 78 | 77.58 percent change | Standard Error 19.98 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 65.34 percent change | Standard Error 19.45 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 22 | 107.88 percent change | Standard Error 19.52 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 79.77 percent change | Standard Error 20.53 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 50 | 128.64 percent change | Standard Error 16.55 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 118.17 percent change | Standard Error 17.03 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | 31.38 percent change | Standard Error 18.42 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 72 | 71.55 percent change | Standard Error 7.88 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -4.43 percent change | Standard Error 9.13 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 7.99 percent change | Standard Error 10.6 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 42.17 percent change | Standard Error 3.9 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 58 | 54.04 percent change | Standard Error 16.51 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | -0.76 percent change | Standard Error 17.8 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 9.53 percent change | Standard Error 9.47 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 103.66 percent change | Standard Error 7.37 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 78 | 49.94 percent change | Standard Error 17.55 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 77.00 percent change | Standard Error 20.31 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | -5.07 percent change | Standard Error 13.01 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 43 | 129.43 percent change | Standard Error 21.06 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 141 | 22.42 percent change | Standard Error 16.17 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 89.15 percent change | Standard Error 12.34 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 11.67 percent change | Standard Error 11.51 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 6 | 32.18 percent change | Standard Error 4.75 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 62 | 64.38 percent change | Standard Error 8.62 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 22 | 117.63 percent change | Standard Error 9.76 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 2 | -0.71 percent change | Standard Error 3.94 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 155 | 5.49 percent change | Standard Error 22.07 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -9.38 percent change | Standard Error 12.06 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 24.94 percent change | Standard Error 9.3 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 36 | 103.87 percent change | Standard Error 22.54 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 69.31 percent change | Standard Error 5.5 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 64.99 percent change | Standard Error 21.83 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 74.50 percent change | Standard Error 16.33 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 60 | 61.32 percent change | Standard Error 17.08 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 76.98 percent change | Standard Error 12.12 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 68.67 percent change | Standard Error 11.96 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 60.58 percent change | Standard Error 14.65 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 43 | 98.49 percent change | Standard Error 17.18 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 72 | 63.76 percent change | Standard Error 15.42 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 74 | 71.99 percent change | Standard Error 11.1 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 36 | 105.96 percent change | Standard Error 14.87 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 76 | 78.57 percent change | Standard Error 13.74 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 78 | 75.17 percent change | Standard Error 23.08 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 22 | 96.08 percent change | Standard Error 13.47 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 54.06 percent change | Standard Error 11.05 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 47.44 percent change | Standard Error 12.82 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 2 | 8.46 percent change | Standard Error 6.5 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -0.83 percent change | Standard Error 9.2 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | -7.63 percent change | Standard Error 7.01 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 6 | 27.78 percent change | Standard Error 7.72 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 141 | -12.85 percent change | Standard Error 12.79 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | 14.97 percent change | Standard Error 8.53 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 155 | 1.76 percent change | Standard Error 10 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 15.32 percent change | Standard Error 7.4 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 5.78 percent change | Standard Error 9.42 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 58.81 percent change | Standard Error 12.45 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 88.21 percent change | Standard Error 11.96 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 50 | 86.45 percent change | Standard Error 14.88 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 2 | -0.64 percent change | Standard Error 13.43 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | -7.07 percent change | Standard Error 10.52 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 6 | 33.83 percent change | Standard Error 19.09 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | -5.88 percent change | Standard Error 9.47 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 64 | 113.79 percent change | Standard Error 18.18 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 123.92 percent change | Standard Error 39.13 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 113 | -7.13 percent change | Standard Error 11.6 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 58 | 82.95 percent change | Standard Error 20.45 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 8 | 70.63 percent change | Standard Error 24.65 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 44.44 percent change | Standard Error 22.42 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 74.16 percent change | Standard Error 19.64 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 78 | 65.32 percent change | Standard Error 13.57 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 43 | 139.62 percent change | Standard Error 31.52 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 22 | 142.64 percent change | Standard Error 34.7 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 60 | 85.82 percent change | Standard Error 19.44 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 36 | 147.40 percent change | Standard Error 32.52 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 115.09 percent change | Standard Error 26.83 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 113.62 percent change | Standard Error 19.09 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 10.72 percent change | Standard Error 15.27 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 62 | 94.88 percent change | Standard Error 12.29 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | 12.17 percent change | Standard Error 16.53 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 155 | -6.88 percent change | Standard Error 9.24 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 141 | -9.24 percent change | Standard Error 8.87 |
Secondary
Percent Change From Baseline in Sclerostin
Time frame: Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169
Population: Treated participants with available data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Sclerostin | Day 85 | -2.2 percent change | Standard Error 5.8 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 169 | 1.9 percent change | Standard Error 9.1 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 113 | -7.3 percent change | Standard Error 6.5 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 99 | -3.5 percent change | Standard Error 6.9 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 29 | -3.6 percent change | Standard Error 5.4 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 15 | -5.6 percent change | Standard Error 4.7 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 43 | 4.4 percent change | Standard Error 8.5 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 155 | 2.6 percent change | Standard Error 9 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 57 | 0.4 percent change | Standard Error 7.2 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 141 | 2.1 percent change | Standard Error 7.5 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 71 | -1.9 percent change | Standard Error 5.7 |
| Placebo | Percent Change From Baseline in Sclerostin | Day 127 | 0.2 percent change | Standard Error 5.8 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 15 | 3135.6 percent change | Standard Error 665.6 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 169 | 76.1 percent change | Standard Error 37.7 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 43 | 4669.2 percent change | Standard Error 1119.6 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 141 | 203.9 percent change | Standard Error 110.6 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 85 | 4886.5 percent change | Standard Error 1085.4 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 99 | 2496.0 percent change | Standard Error 806.8 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 127 | 364.9 percent change | Standard Error 185.9 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 113 | 883.2 percent change | Standard Error 397.5 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 29 | 4068.2 percent change | Standard Error 923.8 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 57 | 5143.9 percent change | Standard Error 1145.2 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 155 | 118.8 percent change | Standard Error 78.9 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 71 | 4949.6 percent change | Standard Error 1133.1 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 169 | 40.3 percent change | Standard Error 27.8 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 71 | 6905.1 percent change | Standard Error 875.7 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 43 | 6229.6 percent change | Standard Error 475.2 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 141 | 84.6 percent change | Standard Error 47.3 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 57 | 3024.9 percent change | Standard Error 290.7 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 155 | 57.4 percent change | Standard Error 35.5 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 85 | 3004.2 percent change | Standard Error 538.5 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 113 | 399.4 percent change | Standard Error 175.9 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 127 | 161.5 percent change | Standard Error 67.9 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 99 | 952.8 percent change | Standard Error 362.7 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 29 | 2335.8 percent change | Standard Error 283.2 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 15 | 5630.4 percent change | Standard Error 478.9 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 155 | 298.6 percent change | Standard Error 67.4 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 15 | 6087.5 percent change | Standard Error 651.1 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 29 | 7713.1 percent change | Standard Error 997.9 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 43 | 9023.8 percent change | Standard Error 1003.7 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 57 | 8450.2 percent change | Standard Error 545 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 71 | 10130.3 percent change | Standard Error 1041.3 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 85 | 10566.4 percent change | Standard Error 1667.4 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 99 | 6748.3 percent change | Standard Error 1165.3 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 113 | 3556.2 percent change | Standard Error 627.9 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 127 | 1410.2 percent change | Standard Error 273 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 141 | 524.3 percent change | Standard Error 109.9 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Sclerostin | Day 169 | 177.3 percent change | Standard Error 37.8 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 127 | 202.6 percent change | Standard Error 58.2 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 15 | 7532.4 percent change | Standard Error 627.8 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 43 | 8471.0 percent change | Standard Error 506.6 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 57 | 6137.5 percent change | Standard Error 1319.7 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 141 | 178.2 percent change | Standard Error 101.5 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 113 | 473.3 percent change | Standard Error 129.2 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 99 | 2124.2 percent change | Standard Error 736.4 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 155 | 41.0 percent change | Standard Error 21.8 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 71 | 9114.5 percent change | Standard Error 812.4 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 29 | 4993.3 percent change | Standard Error 890.2 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 85 | 5403.5 percent change | Standard Error 1285.7 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Sclerostin | Day 169 | 845.3 percent change | Standard Error 528.9 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 99 | 1960.4 percent change | Standard Error 461.1 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 71 | 5405.1 percent change | Standard Error 667.6 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 113 | 395.4 percent change | Standard Error 57 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 57 | 4450.8 percent change | Standard Error 471.5 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 127 | 242.5 percent change | Standard Error 150 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 43 | 4613.9 percent change | Standard Error 486.2 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 169 | 713.7 percent change | Standard Error 688.9 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 141 | 74.2 percent change | Standard Error 25.5 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 29 | 3904.4 percent change | Standard Error 399.2 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 155 | 88.6 percent change | Standard Error 43.3 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 15 | 2809.3 percent change | Standard Error 241.8 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Sclerostin | Day 85 | 5254.5 percent change | Standard Error 588.9 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 99 | 2183.7 percent change | Standard Error 520.7 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 57 | 4739.5 percent change | Standard Error 660.2 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 113 | 804.9 percent change | Standard Error 257.7 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 169 | 16.8 percent change | Standard Error 20.9 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 155 | 48.3 percent change | Standard Error 36.6 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 15 | 6816.0 percent change | Standard Error 775.1 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 71 | 7735.8 percent change | Standard Error 949.8 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 43 | 6486.0 percent change | Standard Error 621.2 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 85 | 4873.7 percent change | Standard Error 520.7 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 141 | 128.2 percent change | Standard Error 61.5 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 127 | 311.3 percent change | Standard Error 117.9 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Sclerostin | Day 29 | 4573.0 percent change | Standard Error 614.4 |
Secondary
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 113 | -15.61 percent change | Standard Error 6.74 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 74 | -6.15 percent change | Standard Error 8.32 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 141 | -21.10 percent change | Standard Error 6.53 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 62 | -14.01 percent change | Standard Error 10.87 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 85 | -12.69 percent change | Standard Error 5.84 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 76 | -19.35 percent change | Standard Error 5.7 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 6 | -12.60 percent change | Standard Error 5.74 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 78 | -18.50 percent change | Standard Error 6.03 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 58 | -20.27 percent change | Standard Error 7.58 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 22 | -12.98 percent change | Standard Error 6.18 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 29 | -10.94 percent change | Standard Error 6.87 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 155 | -21.03 percent change | Standard Error 5.72 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 4 | -5.51 percent change | Standard Error 5.87 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 43 | -14.14 percent change | Standard Error 7.4 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 64 | -10.22 percent change | Standard Error 7.59 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 2 | -7.31 percent change | Standard Error 4.3 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 169 | -16.59 percent change | Standard Error 6.74 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 71 | -15.23 percent change | Standard Error 5.58 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 15 | -18.86 percent change | Standard Error 5.92 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 127 | -19.03 percent change | Standard Error 5.79 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 50 | -12.62 percent change | Standard Error 7.98 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 60 | -14.95 percent change | Standard Error 10.06 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 99 | -20.31 percent change | Standard Error 5.21 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 8 | -17.79 percent change | Standard Error 5.06 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 72 | -19.21 percent change | Standard Error 6.72 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 36 | -20.96 percent change | Standard Error 7.87 |
| Placebo | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 57 | -17.59 percent change | Standard Error 6.11 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 155 | -0.02 percent change | Standard Error 8.21 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 57 | 14.35 percent change | Standard Error 10.32 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 22 | -4.88 percent change | Standard Error 9.99 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 169 | -1.13 percent change | Standard Error 8.37 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 71 | 26.63 percent change | Standard Error 14.92 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 113 | 4.66 percent change | Standard Error 11.35 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 72 | 11.70 percent change | Standard Error 13.66 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 74 | 7.40 percent change | Standard Error 11.86 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 76 | 11.70 percent change | Standard Error 9.88 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 78 | 9.18 percent change | Standard Error 11.45 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 85 | 14.95 percent change | Standard Error 13.45 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 99 | 7.45 percent change | Standard Error 8.41 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 50 | -4.78 percent change | Standard Error 11.11 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 127 | -5.63 percent change | Standard Error 13.21 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 141 | 4.86 percent change | Standard Error 10.74 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 43 | 3.91 percent change | Standard Error 9.4 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 2 | 12.29 percent change | Standard Error 9.15 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 4 | 1.10 percent change | Standard Error 12.49 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 64 | 6.59 percent change | Standard Error 16.03 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 36 | 4.50 percent change | Standard Error 11.96 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 6 | -8.29 percent change | Standard Error 12.56 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 8 | -14.65 percent change | Standard Error 11.02 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 29 | 0.31 percent change | Standard Error 6.08 |
| Romosozumab 1 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 15 | -14.39 percent change | Standard Error 9.41 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 4 | -19.03 percent change | Standard Error 9.12 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 8 | -31.59 percent change | Standard Error 10.22 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 29 | -21.11 percent change | Standard Error 8.86 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 36 | -21.42 percent change | Standard Error 12.02 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 15 | -35.11 percent change | Standard Error 8.69 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 169 | -9.38 percent change | Standard Error 12.56 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 22 | -29.97 percent change | Standard Error 12.42 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 6 | -26.11 percent change | Standard Error 10.32 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 127 | -12.96 percent change | Standard Error 12.78 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 2 | -11.32 percent change | Standard Error 4.22 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 78 | -14.82 percent change | Standard Error 10.85 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 62 | -25.09 percent change | Standard Error 10.87 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 141 | -12.11 percent change | Standard Error 14.71 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 99 | -15.79 percent change | Standard Error 9.03 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 57 | -4.53 percent change | Standard Error 17.99 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 58 | -9.15 percent change | Standard Error 9.82 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 64 | -20.16 percent change | Standard Error 8.81 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 85 | 8.97 percent change | Standard Error 10.9 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 155 | -3.37 percent change | Standard Error 12.01 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 71 | -14.42 percent change | Standard Error 11.82 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 60 | -8.80 percent change | Standard Error 13.64 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 43 | -13.79 percent change | Standard Error 15.06 |
| Romosozumab 2 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 113 | -18.77 percent change | Standard Error 12.28 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 50 | -26.11 percent change | Standard Error 5.9 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 64 | -20.09 percent change | Standard Error 4.55 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 99 | -7.79 percent change | Standard Error 8.64 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 141 | 1.99 percent change | Standard Error 9.89 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 29 | -25.43 percent change | Standard Error 6.08 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 71 | -18.24 percent change | Standard Error 7.26 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 127 | 0.46 percent change | Standard Error 10.01 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 169 | -0.92 percent change | Standard Error 15.29 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 43 | -34.04 percent change | Standard Error 3.35 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 113 | 0.18 percent change | Standard Error 13.58 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 8 | -28.92 percent change | Standard Error 3.05 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 2 | 8.05 percent change | Standard Error 9.96 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 155 | 7.94 percent change | Standard Error 6.33 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 36 | -38.33 percent change | Standard Error 2.21 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 22 | -37.34 percent change | Standard Error 3.5 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 4 | -26.84 percent change | Standard Error 4.63 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 15 | -35.27 percent change | Standard Error 4.3 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 76 | -17.14 percent change | Standard Error 9.24 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 6 | -28.04 percent change | Standard Error 7.7 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 78 | -17.99 percent change | Standard Error 10.44 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 57 | -23.74 percent change | Standard Error 6.45 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 85 | -13.06 percent change | Standard Error 9.08 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 74 | -16.32 percent change | Standard Error 6.94 |
| Romosozumab 2 mg/kg Q2W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 72 | -17.32 percent change | Standard Error 7.84 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 22 | -22.85 percent change | Standard Error 7.88 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 60 | -22.34 percent change | Standard Error 16.06 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 62 | -21.83 percent change | Standard Error 18.62 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 64 | -18.72 percent change | Standard Error 14.04 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 71 | -14.03 percent change | Standard Error 13.6 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 78 | 11.88 percent change | Standard Error 21.63 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 85 | 13.77 percent change | Standard Error 22.18 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 99 | -5.14 percent change | Standard Error 17.67 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 113 | -7.88 percent change | Standard Error 13.06 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 127 | -4.92 percent change | Standard Error 18.73 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 2 | -7.07 percent change | Standard Error 7.36 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 4 | -25.85 percent change | Standard Error 7.05 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 6 | -36.98 percent change | Standard Error 5.38 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 8 | -35.93 percent change | Standard Error 3.9 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 15 | -33.00 percent change | Standard Error 7.65 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 57 | -13.47 percent change | Standard Error 15.73 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 155 | 1.27 percent change | Standard Error 14.71 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 169 | -0.27 percent change | Standard Error 10.41 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 29 | -21.54 percent change | Standard Error 10.95 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 36 | -29.20 percent change | Standard Error 15.71 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 43 | -20.49 percent change | Standard Error 12.73 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 58 | -9.63 percent change | Standard Error 15.05 |
| Romosozumab 3 mg/kg Q4W in Women | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 141 | 13.34 percent change | Standard Error 14.8 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 113 | -10.06 percent change | Standard Error 10.22 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 6 | -28.83 percent change | Standard Error 6.44 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 50 | -22.42 percent change | Standard Error 15.96 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 85 | -16.89 percent change | Standard Error 16.84 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 2 | -10.15 percent change | Standard Error 10.74 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 78 | -5.24 percent change | Standard Error 18.22 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 57 | -25.25 percent change | Standard Error 12.27 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 8 | -42.09 percent change | Standard Error 4.09 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 76 | -17.12 percent change | Standard Error 13.7 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 74 | -9.80 percent change | Standard Error 14.64 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 141 | -22.48 percent change | Standard Error 5.32 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 99 | -13.22 percent change | Standard Error 17.06 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 4 | -22.01 percent change | Standard Error 3.66 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 72 | -8.98 percent change | Standard Error 16.64 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 127 | 1.68 percent change | Standard Error 14.91 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 71 | -11.02 percent change | Standard Error 18.12 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 29 | -32.76 percent change | Standard Error 4.85 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 169 | -15.61 percent change | Standard Error 11.74 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 155 | -14.43 percent change | Standard Error 12.92 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 43 | -28.54 percent change | Standard Error 6.07 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 22 | -36.63 percent change | Standard Error 6.67 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 15 | -39.34 percent change | Standard Error 2.85 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 64 | -20.03 percent change | Standard Error 12.81 |
| Romosozumab 1 mg/kg Q2W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 36 | -36.51 percent change | Standard Error 9.31 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 155 | -15.00 percent change | Standard Error 14.96 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 169 | -10.10 percent change | Standard Error 9.54 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 8 | -43.93 percent change | Standard Error 3.44 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 6 | -35.78 percent change | Standard Error 3.37 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 62 | -41.37 percent change | Standard Error 8.69 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 29 | -34.53 percent change | Standard Error 8.14 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 4 | -34.13 percent change | Standard Error 3.28 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 2 | -6.57 percent change | Standard Error 3.5 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 60 | -28.04 percent change | Standard Error 11.68 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 36 | -50.32 percent change | Standard Error 4.78 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 141 | -21.35 percent change | Standard Error 9.69 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 127 | -16.92 percent change | Standard Error 13 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 58 | -28.19 percent change | Standard Error 8.64 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 43 | -44.64 percent change | Standard Error 7.31 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 113 | -8.20 percent change | Standard Error 12.19 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 85 | -17.17 percent change | Standard Error 10.09 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 78 | -21.66 percent change | Standard Error 11.5 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 57 | -31.52 percent change | Standard Error 7.89 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 99 | -8.18 percent change | Standard Error 10.8 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 71 | -38.38 percent change | Standard Error 4.37 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 64 | -34.86 percent change | Standard Error 10.25 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 22 | -39.21 percent change | Standard Error 4.7 |
| Romosozumab 3 mg/kg Q4W in Men | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Day 15 | -48.74 percent change | Standard Error 5.56 |
Secondary
Time to Maximum Observed Concentration (Tmax) of Romosozumab
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Maximum Observed Concentration (Tmax) of Romosozumab | First dose | 3.0 days |
| Placebo | Time to Maximum Observed Concentration (Tmax) of Romosozumab | Last dose | 3.0 days |
| Romosozumab 1 mg/kg Q2W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | First dose | 3.0 days |
| Romosozumab 1 mg/kg Q2W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | Last dose | 3.0 days |
| Romosozumab 2 mg/kg Q4W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | First dose | 4.5 days |
| Romosozumab 2 mg/kg Q4W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | Last dose | 3.5 days |
| Romosozumab 2 mg/kg Q2W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | First dose | 3.0 days |
| Romosozumab 2 mg/kg Q2W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | Last dose | 5.0 days |
| Romosozumab 3 mg/kg Q4W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | First dose | 3.0 days |
| Romosozumab 3 mg/kg Q4W in Women | Time to Maximum Observed Concentration (Tmax) of Romosozumab | Last dose | 3.0 days |
| Romosozumab 1 mg/kg Q2W in Men | Time to Maximum Observed Concentration (Tmax) of Romosozumab | First dose | 5.0 days |
| Romosozumab 1 mg/kg Q2W in Men | Time to Maximum Observed Concentration (Tmax) of Romosozumab | Last dose | 3.0 days |