Osteopenia
Conditions
Keywords
Amgen, Postmenopausal, Bone Density
Brief summary
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in 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
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy females between 55 to 80 years of age * Postmenopausal females (based on medical history) defined as 12 continuous months of spontaneous amenorrhea * Women 60 years of age and older will be considered postmenopausal * Women 55-59 must have a serum follicle-stimulating hormone result \> 40 mIU/mL and serum estradiol ≤ 20 pg/mL * Low bone mineral density (BMD), defined as a BMD T-score between -1.0 and -2.5 at the lumbar spine (L1-L4) and/or femoral neck * Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in) * 25-hydroxyvitamin D ≥ 20 ng/mL at screening * Willing and able to take ≥ 500 mg calcium and ≥ 400 IU (but ≤ 1,000 IU) vitamin D daily
Exclusion criteria
* Osteoporosis, defined as a BMD T-score ≤ -2.5 at the lumbar spine or femoral neck * History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis * Diagnosed with any condition that will affect bone metabolism * Subjects with fewer than 2 evaluable vertebrae; metal in forearms bilaterally that would not allow for at least one evaluable forearm * Administration of the following medications within 6 months before study drug administration. This includes all routes of administration, for example intranasal and topical skin patches, unless otherwise noted: * Hormone replacement therapy \[(eg, estrogen, estrogen-like compounds such as raloxifene). Infrequent use of estrogen vaginal creams (\< 3 times per week) is allowed.\] * Calcitonin * Parathyroid hormone (or any derivative) * Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed) * Anabolic steroids * Calcitriol, and available analogues * Administration of daily, weekly, or monthly bisphosphonates (BP) unless meeting the following criteria: * \< 2 weeks of BP use requires a 2-month washout period * 2 weeks to 3 months of BP use requires a 9-month washout period * 3 to 6 months of BP use requires a 1-year washout period * \> 6 months of BP use requires a 3-year washout period; * Greatly differing levels of physical activity or constant levels of intense physical exercise during the 6 months before study drug administration * Known sensitivity to mammalian-derived drug preparations * Known to be hepatitis B surface antigen, hepatitis C virus or human Immunodeficiency virus (HIV) positive or a known diagnosis of acquired immunodeficiency syndrome (AIDS) * Any organic or psychiatric disorder, which, in the opinion of the investigator, poses a risk to subject safety and may prevent the subject from completing the study or interfere with the interpretation of the study results * Unavailable for follow-up assessment or any concerns for subject's compliance with the protocol procedures * Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent * History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion * Clinically significant abnormality during the screening physical examination, electrocardiogram (ECG) or laboratory evaluation * Participation in another clinical study within 4 weeks of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known * Has donated or lost 400 mL or more of blood or plasma within 8 weeks of study drug administration * Previous AMG 785 exposure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | The polar moment of inertia is a geometric measurement used to predict bone quality, specifically the ability to resist torsion (twisting), and is highly correlated with fracture load at the distal radius. The polar cross-sectional moment of inertia was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Cortical bone area was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Cortical bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Cortical bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Endocortical circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Periosteal circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Cortical Thickness at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Cortical thickness was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Polar section modulus is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Axial moment of inertia is an indicator of the ability of bone to resist bending, and was derived from pQCT measurements based on a circular ring model. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Baseline and days 29, 57, 85, 127, and 169 | Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Baseline and days 29, 57, 85, 127, and 169 | Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Baseline and days 29, 57, 85, 127, and 169 | Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Baseline and days 29, 57, 85, 127, and 169 | Trabecular bone area was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Total Bone Area at the Distal Radius | Baseline and days 29, 57, 85, 127, and 169 | Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Baseline and days 29, 57, 85, 127, and 169 | Trabecular bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Baseline and days 29, 57, 85, 127, and 169 | The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
| Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Baseline and days 29, 57, 85, 127, and 169 | Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader. |
| Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Baseline and days 29, 57, 85, 127, and 169 | Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader. |
| Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine | Baseline and days 85 and 169 | Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader. |
| Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169 | — |
| Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169 | — |
| Time to Maximum Serum Concentration (Tmax) of Romosozumab | First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169 | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL. |
| Maximum Serum Concentration (Cmax) of Romosozumab | First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169 | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL. |
| Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28) | First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169 | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL. The area under the serum drug concentration-time curve from time zero to tau (tau = 28 days) (AUC0-28) was calculated by the linear trapezoidal method. |
| Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) | Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169 | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL. |
| Apparent Clearance (CL/F) of Romosozumab | Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169 | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL. |
| Terminal Half-life (t1/2,z) of Romosozumab | Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169 | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL. |
| Accumulation Ratio | First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169 | Accumulation ratio was calculated as the ratio of AUC0-28 after the last dose to AUC0-28 after the first dose. |
| Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Baseline and days 29, 57, 85, 127, and 169 | Trabecular bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader. |
Participant flow
Recruitment details
This study was conducted at a single center in the United States.
Pre-assignment details
Participants were equally randomized to receive romosozumab or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. | 12 |
| Romosozumab Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Romosozumab | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 5.6 | 65.6 years STANDARD_DEVIATION 7.2 | 63.9 years STANDARD_DEVIATION 6.5 |
| Age, Customized 18 - 64 years | 9 Participants | 6 Participants | 15 Participants |
| Age, Customized 65 - 74 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Customized ≥ 75 years | 0 Participants | 2 Participants | 2 Participants |
| Polar Moment of Inertia | 1545.14 mm⁴ | 1496.50 mm⁴ | 1501.96 mm⁴ |
| Race/Ethnicity, Customized White | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 12 | 10 / 12 |
| serious Total, serious adverse events | 1 / 12 | 1 / 12 |
Outcome results
Primary
Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius
The polar moment of inertia is a geometric measurement used to predict bone quality, specifically the ability to resist torsion (twisting), and is highly correlated with fracture load at the distal radius. The polar cross-sectional moment of inertia was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 57 | -1.03 percent change | Standard Error 1 |
| Placebo | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 127 | -1.93 percent change | Standard Error 1.22 |
| Placebo | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 85 | -2.28 percent change | Standard Error 1.21 |
| Placebo | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 169 | -1.66 percent change | Standard Error 1.22 |
| Placebo | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 29 | -1.16 percent change | Standard Error 1.4 |
| Romosozumab | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 169 | -0.08 percent change | Standard Error 1.12 |
| Romosozumab | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 29 | 0.16 percent change | Standard Error 0.95 |
| Romosozumab | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 57 | -1.03 percent change | Standard Error 1.19 |
| Romosozumab | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 85 | 1.45 percent change | Standard Error 1.03 |
| Romosozumab | Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius | Day 127 | 0.87 percent change | Standard Error 0.89 |
Secondary
Accumulation Ratio
Accumulation ratio was calculated as the ratio of AUC0-28 after the last dose to AUC0-28 after the first dose.
Time frame: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Accumulation Ratio | 1.15 ratio | Standard Deviation 0.27 |
Secondary
Apparent Clearance (CL/F) 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: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Apparent Clearance (CL/F) of Romosozumab | 5.82 mL/day/kg | Standard Deviation 2.12 |
Secondary
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf)
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: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) | 590 μg*day/mL | Standard Deviation 240 |
Secondary
Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28)
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL. The area under the serum drug concentration-time curve from time zero to tau (tau = 28 days) (AUC0-28) was calculated by the linear trapezoidal method.
Time frame: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28) | First dose | 422 μg*day/mL | Standard Deviation 75 |
| Placebo | Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28) | Last dose | 501 μg*day/mL | Standard Deviation 179 |
Secondary
Maximum Serum Concentration (Cmax) 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: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Serum Concentration (Cmax) of Romosozumab | First dose | 26.8 μg/mL | Standard Deviation 6.4 |
| Placebo | Maximum Serum Concentration (Cmax) of Romosozumab | Last dose | 32.3 μg/mL | Standard Deviation 9.6 |
Secondary
Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius
Axial moment of inertia is an indicator of the ability of bone to resist bending, and was derived from pQCT measurements based on a circular ring model. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 57 | -0.19 percent change | Standard Error 0.74 |
| Placebo | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 127 | -0.90 percent change | Standard Error 0.65 |
| Placebo | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 85 | -1.90 percent change | Standard Error 1.09 |
| Placebo | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 169 | -1.25 percent change | Standard Error 0.75 |
| Placebo | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 29 | -0.22 percent change | Standard Error 0.91 |
| Romosozumab | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 169 | -0.28 percent change | Standard Error 0.98 |
| Romosozumab | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 29 | -0.23 percent change | Standard Error 0.73 |
| Romosozumab | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 57 | -0.49 percent change | Standard Error 0.88 |
| Romosozumab | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 85 | 0.94 percent change | Standard Error 0.83 |
| Romosozumab | Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius | Day 127 | 1.41 percent change | Standard Error 1.04 |
Secondary
Percent Change From Baseline in Bone Mineral Density at the One-third Radius
Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 57 | 0.832 percent change | Standard Error 1.155 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 127 | -0.118 percent change | Standard Error 1.405 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 85 | 0.790 percent change | Standard Error 1.117 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 169 | 1.866 percent change | Standard Error 0.905 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 29 | 1.715 percent change | Standard Error 0.808 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 169 | -0.328 percent change | Standard Error 0.702 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 29 | 1.210 percent change | Standard Error 0.814 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 57 | -0.694 percent change | Standard Error 0.827 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 85 | -1.941 percent change | Standard Error 0.986 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the One-third Radius | Day 127 | -0.439 percent change | Standard Error 1.346 |
Secondary
Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine
Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.
Time frame: Baseline and days 85 and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine | Day 85 | 0.345 percent change | Standard Error 1.224 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine | Day 169 | 0.149 percent change | Standard Error 0.905 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine | Day 85 | 4.786 percent change | Standard Error 0.846 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine | Day 169 | 7.876 percent change | Standard Error 1.351 |
Secondary
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | 1.829 percent change | Standard Error 0.617 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 57 | 0.940 percent change | Standard Error 1.081 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | 0.233 percent change | Standard Error 0.996 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | 0.001 percent change | Standard Error 1.081 |
| Placebo | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | 0.357 percent change | Standard Error 1.237 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 169 | -0.649 percent change | Standard Error 0.522 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 127 | -0.369 percent change | Standard Error 0.765 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 57 | -1.651 percent change | Standard Error 0.574 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 29 | -0.555 percent change | Standard Error 0.428 |
| Romosozumab | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Day 85 | -1.690 percent change | Standard Error 0.733 |
Secondary
Percent Change From Baseline in Cortical Bone Area at the Distal Radius
Cortical bone area was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 127 | -1.41 percent change | Standard Error 0.81 |
| Placebo | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 29 | -0.27 percent change | Standard Error 0.58 |
| Placebo | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 169 | -1.59 percent change | Standard Error 0.58 |
| Placebo | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 57 | -0.05 percent change | Standard Error 0.54 |
| Placebo | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 85 | -1.39 percent change | Standard Error 0.77 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 57 | -0.53 percent change | Standard Error 0.64 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 85 | 0.69 percent change | Standard Error 0.67 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 127 | 0.28 percent change | Standard Error 0.63 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 169 | -0.50 percent change | Standard Error 0.74 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Area at the Distal Radius | Day 29 | 0.06 percent change | Standard Error 0.63 |
Secondary
Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius
Cortical bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 169 | -1.69 percent change | Standard Error 0.55 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 57 | -0.29 percent change | Standard Error 0.52 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 29 | -0.33 percent change | Standard Error 0.57 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 85 | -1.08 percent change | Standard Error 0.66 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 127 | -1.45 percent change | Standard Error 0.82 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 127 | -0.66 percent change | Standard Error 0.57 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 85 | -0.07 percent change | Standard Error 0.66 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 169 | -1.29 percent change | Standard Error 0.67 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 29 | 0.07 percent change | Standard Error 0.46 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius | Day 57 | -0.86 percent change | Standard Error 0.45 |
Secondary
Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius
Cortical bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 169 | -0.10 percent change | Standard Error 0.23 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 29 | -0.06 percent change | Standard Error 0.1 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 57 | -0.24 percent change | Standard Error 0.21 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 85 | 0.32 percent change | Standard Error 0.24 |
| Placebo | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 127 | -0.04 percent change | Standard Error 0.23 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 127 | -0.92 percent change | Standard Error 0.4 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 85 | -0.76 percent change | Standard Error 0.23 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 29 | 0.02 percent change | Standard Error 0.21 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 169 | -0.79 percent change | Standard Error 0.31 |
| Romosozumab | Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius | Day 57 | -0.32 percent change | Standard Error 0.28 |
Secondary
Percent Change From Baseline in Cortical Thickness at the Distal Radius
Cortical thickness was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 57 | 0.09 percent change | Standard Error 0.79 |
| Placebo | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 127 | -1.69 percent change | Standard Error 1.14 |
| Placebo | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 85 | -1.14 percent change | Standard Error 0.72 |
| Placebo | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 169 | -1.82 percent change | Standard Error 0.78 |
| Placebo | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 29 | -0.29 percent change | Standard Error 0.82 |
| Romosozumab | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 169 | -0.62 percent change | Standard Error 1.09 |
| Romosozumab | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 29 | 0.22 percent change | Standard Error 0.77 |
| Romosozumab | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 57 | -0.56 percent change | Standard Error 0.85 |
| Romosozumab | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 85 | 0.64 percent change | Standard Error 0.99 |
| Romosozumab | Percent Change From Baseline in Cortical Thickness at the Distal Radius | Day 127 | -0.31 percent change | Standard Error 0.8 |
Secondary
Percent Change From Baseline in Endocortical Circumference at the Distal Radius
Endocortical circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 57 | -0.23 percent change | Standard Error 0.73 |
| Placebo | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 127 | 0.77 percent change | Standard Error 0.8 |
| Placebo | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 85 | -0.03 percent change | Standard Error 0.39 |
| Placebo | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 169 | 0.85 percent change | Standard Error 0.66 |
| Placebo | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 29 | 0.20 percent change | Standard Error 0.74 |
| Romosozumab | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 169 | 0.49 percent change | Standard Error 0.84 |
| Romosozumab | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 29 | -0.19 percent change | Standard Error 0.5 |
| Romosozumab | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 57 | 0.26 percent change | Standard Error 0.67 |
| Romosozumab | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 85 | -0.07 percent change | Standard Error 0.72 |
| Romosozumab | Percent Change From Baseline in Endocortical Circumference at the Distal Radius | Day 127 | 0.89 percent change | Standard Error 0.66 |
Secondary
Percent Change From Baseline in Periosteal Circumference at the Distal Radius
Periosteal circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 57 | -0.04 percent change | Standard Error 0.24 |
| Placebo | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 127 | 0.02 percent change | Standard Error 0.22 |
| Placebo | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 85 | -0.40 percent change | Standard Error 0.25 |
| Placebo | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 169 | -0.12 percent change | Standard Error 0.23 |
| Placebo | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 29 | -0.04 percent change | Standard Error 0.28 |
| Romosozumab | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 169 | -0.02 percent change | Standard Error 0.35 |
| Romosozumab | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 29 | -0.11 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 57 | -0.07 percent change | Standard Error 0.28 |
| Romosozumab | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 85 | 0.19 percent change | Standard Error 0.31 |
| Romosozumab | Percent Change From Baseline in Periosteal Circumference at the Distal Radius | Day 127 | 0.43 percent change | Standard Error 0.33 |
Secondary
Percent Change From Baseline in Polar Section Modulus at the Distal Radius
Polar section modulus is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 57 | -0.11 percent change | Standard Error 1.08 |
| Placebo | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 127 | -2.31 percent change | Standard Error 1.55 |
| Placebo | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 85 | -2.14 percent change | Standard Error 1.4 |
| Placebo | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 169 | -1.67 percent change | Standard Error 1.14 |
| Placebo | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 29 | 0.18 percent change | Standard Error 0.78 |
| Romosozumab | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 169 | -1.05 percent change | Standard Error 1.2 |
| Romosozumab | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 29 | 0.02 percent change | Standard Error 0.78 |
| Romosozumab | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 57 | -0.46 percent change | Standard Error 1.05 |
| Romosozumab | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 85 | 0.93 percent change | Standard Error 1.22 |
| Romosozumab | Percent Change From Baseline in Polar Section Modulus at the Distal Radius | Day 127 | 1.76 percent change | Standard Error 1.32 |
Secondary
Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius
The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 57 | -1.32 percent change | Standard Error 0.75 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 127 | -0.71 percent change | Standard Error 0.95 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 85 | 0.36 percent change | Standard Error 0.99 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 169 | -0.41 percent change | Standard Error 0.98 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 29 | -1.85 percent change | Standard Error 0.81 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 169 | -1.25 percent change | Standard Error 0.78 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 29 | -0.78 percent change | Standard Error 0.51 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 57 | -1.47 percent change | Standard Error 1.21 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 85 | -1.91 percent change | Standard Error 1.49 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius | Day 127 | -1.57 percent change | Standard Error 0.94 |
Secondary
Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius
The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 85 | 1.08 percent change | Standard Error 1.71 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 127 | -0.87 percent change | Standard Error 1.29 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 169 | -0.25 percent change | Standard Error 1.61 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 29 | 2.69 percent change | Standard Error 2.36 |
| Placebo | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 57 | 2.28 percent change | Standard Error 1.47 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 57 | 1.28 percent change | Standard Error 2.06 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 85 | -0.90 percent change | Standard Error 2.3 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 29 | -0.14 percent change | Standard Error 1 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 127 | -0.89 percent change | Standard Error 1.95 |
| Romosozumab | Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius | Day 169 | -1.51 percent change | Standard Error 1.86 |
Secondary
Percent Change From Baseline in Serum C-Telopeptide (sCTX)
Time frame: Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 57 | 7.87 percent change | Standard Error 6.49 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 4 | 6.62 percent change | Standard Error 4.33 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 15 | -2.29 percent change | Standard Error 5.15 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 29 | -3.19 percent change | Standard Error 8.83 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 62 | 8.69 percent change | Standard Error 5.78 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 71 | 5.60 percent change | Standard Error 5.59 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 85 | -3.00 percent change | Standard Error 7.94 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 99 | -9.14 percent change | Standard Error 8.17 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 127 | -10.00 percent change | Standard Error 8.91 |
| Placebo | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 169 | -3.61 percent change | Standard Error 8.95 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 99 | 14.29 percent change | Standard Error 23.73 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 71 | -14.72 percent change | Standard Error 13.84 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 4 | -23.77 percent change | Standard Error 7.78 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 169 | 16.06 percent change | Standard Error 20.53 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 15 | -33.10 percent change | Standard Error 8.85 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 85 | 4.85 percent change | Standard Error 19.28 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 29 | -21.42 percent change | Standard Error 13.98 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 57 | 7.26 percent change | Standard Error 16.28 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 127 | 6.32 percent change | Standard Error 16.6 |
| Romosozumab | Percent Change From Baseline in Serum C-Telopeptide (sCTX) | Day 62 | -12.67 percent change | Standard Error 15.15 |
Secondary
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | -4.40 percent change | Standard Error 6.13 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 3.46 percent change | Standard Error 5.64 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | -0.33 percent change | Standard Error 3.44 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | -6.93 percent change | Standard Error 4.52 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 62 | 0.27 percent change | Standard Error 9.2 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 19.61 percent change | Standard Error 16.22 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 23.83 percent change | Standard Error 17.11 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | 10.94 percent change | Standard Error 15.57 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | 5.49 percent change | Standard Error 10.26 |
| Placebo | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 20.85 percent change | Standard Error 10.44 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 99 | 17.07 percent change | Standard Error 11.79 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 4 | 36.37 percent change | Standard Error 10.02 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 71 | 106.91 percent change | Standard Error 14.08 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 15 | 146.39 percent change | Standard Error 20 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 169 | 33.80 percent change | Standard Error 13.64 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 29 | 101.85 percent change | Standard Error 19.97 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 85 | 67.85 percent change | Standard Error 19.11 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 57 | 74.77 percent change | Standard Error 10.91 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 127 | 12.56 percent change | Standard Error 8.57 |
| Romosozumab | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Day 62 | 92.22 percent change | Standard Error 14.71 |
Secondary
Percent Change From Baseline in Total Bone Area at the Distal Radius
Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 29 | -0.07 percent change | Standard Error 0.56 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 57 | -0.08 percent change | Standard Error 0.48 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 85 | -0.79 percent change | Standard Error 0.49 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 169 | -0.23 percent change | Standard Error 0.46 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 127 | 0.05 percent change | Standard Error 0.43 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 127 | 0.87 percent change | Standard Error 0.66 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 29 | -0.21 percent change | Standard Error 0.4 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 85 | 0.38 percent change | Standard Error 0.61 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 57 | -0.13 percent change | Standard Error 0.56 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Distal Radius | Day 169 | -0.04 percent change | Standard Error 0.7 |
Secondary
Percent Change From Baseline in Total Bone Area at the Ultradistal Radius
Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 85 | -0.27 percent change | Standard Error 2.37 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 29 | -2.30 percent change | Standard Error 3.64 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 127 | -0.43 percent change | Standard Error 2.46 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 169 | 1.90 percent change | Standard Error 2.5 |
| Placebo | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 57 | -5.11 percent change | Standard Error 2.44 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 169 | 0.91 percent change | Standard Error 3.32 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 29 | -0.72 percent change | Standard Error 2.35 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 85 | 7.35 percent change | Standard Error 3.21 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 127 | 3.27 percent change | Standard Error 2.96 |
| Romosozumab | Percent Change From Baseline in Total Bone Area at the Ultradistal Radius | Day 57 | -0.01 percent change | Standard Error 3.66 |
Secondary
Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius
Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 57 | -0.33 percent change | Standard Error 0.37 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 127 | -0.66 percent change | Standard Error 0.36 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 85 | -0.86 percent change | Standard Error 0.47 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 169 | -1.34 percent change | Standard Error 0.3 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 29 | -0.39 percent change | Standard Error 0.4 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 169 | -1.09 percent change | Standard Error 0.36 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 29 | -0.27 percent change | Standard Error 0.41 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 57 | -0.49 percent change | Standard Error 0.27 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 85 | -0.51 percent change | Standard Error 0.36 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius | Day 127 | -0.43 percent change | Standard Error 0.37 |
Secondary
Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius
Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 127 | 0.46 percent change | Standard Error 0.56 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 29 | 0.63 percent change | Standard Error 0.43 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 57 | 0.13 percent change | Standard Error 0.53 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 85 | 0.63 percent change | Standard Error 0.56 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 169 | 0.15 percent change | Standard Error 0.59 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 169 | -0.64 percent change | Standard Error 0.97 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 85 | 1.16 percent change | Standard Error 0.39 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 29 | -0.30 percent change | Standard Error 0.7 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 127 | -0.14 percent change | Standard Error 0.46 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius | Day 57 | -0.09 percent change | Standard Error 0.63 |
Secondary
Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius
Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 57 | -0.24 percent change | Standard Error 0.38 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 127 | -0.69 percent change | Standard Error 0.48 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 85 | -0.07 percent change | Standard Error 0.19 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 169 | -0.10 percent change | Standard Error 0.42 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 29 | -0.30 percent change | Standard Error 0.48 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 169 | -1.02 percent change | Standard Error 0.55 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 29 | -0.06 percent change | Standard Error 0.3 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 57 | -0.34 percent change | Standard Error 0.44 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 85 | -0.86 percent change | Standard Error 0.53 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius | Day 127 | -1.26 percent change | Standard Error 0.53 |
Secondary
Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius
Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 57 | 6.22 percent change | Standard Error 3.19 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 127 | 1.43 percent change | Standard Error 2.35 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 85 | 1.52 percent change | Standard Error 2.64 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 169 | -1.14 percent change | Standard Error 2.72 |
| Placebo | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 29 | 4.45 percent change | Standard Error 4.42 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 169 | -0.81 percent change | Standard Error 2.59 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 29 | 0.91 percent change | Standard Error 1.97 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 57 | 1.19 percent change | Standard Error 2.98 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 85 | -4.95 percent change | Standard Error 2.33 |
| Romosozumab | Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius | Day 127 | -2.53 percent change | Standard Error 2.38 |
Secondary
Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius
Trabecular bone area was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 29 | -3.54 percent change | Standard Error 5.68 |
| Placebo | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 127 | -1.86 percent change | Standard Error 4.01 |
| Placebo | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 57 | -8.06 percent change | Standard Error 3.86 |
| Placebo | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 169 | 2.84 percent change | Standard Error 4.18 |
| Placebo | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 85 | -0.55 percent change | Standard Error 3.82 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 169 | 1.57 percent change | Standard Error 5.2 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 85 | 12.00 percent change | Standard Error 5.84 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 29 | -0.64 percent change | Standard Error 3.59 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 57 | 0.43 percent change | Standard Error 6.21 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius | Day 127 | 5.60 percent change | Standard Error 5.22 |
Secondary
Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius
Trabecular bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 57 | -9.52 percent change | Standard Error 4.68 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 127 | -0.70 percent change | Standard Error 6.15 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 85 | 1.02 percent change | Standard Error 5.51 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 169 | 5.12 percent change | Standard Error 5.55 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 29 | -3.26 percent change | Standard Error 7.35 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 169 | 1.74 percent change | Standard Error 6.71 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 29 | -0.52 percent change | Standard Error 4.78 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 57 | 0.02 percent change | Standard Error 7.61 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 85 | 14.64 percent change | Standard Error 7.06 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius | Day 127 | 5.68 percent change | Standard Error 6.54 |
Secondary
Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius
Trabecular bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Time frame: Baseline and days 29, 57, 85, 127, and 169
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 57 | -1.98 percent change | Standard Error 1.16 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 127 | 0.53 percent change | Standard Error 1.92 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 85 | 0.98 percent change | Standard Error 1.64 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 169 | 1.74 percent change | Standard Error 1.47 |
| Placebo | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 29 | -0.78 percent change | Standard Error 1.88 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 169 | -0.51 percent change | Standard Error 1.64 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 29 | -0.34 percent change | Standard Error 1.33 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 57 | -1.30 percent change | Standard Error 1.59 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 85 | 2.00 percent change | Standard Error 0.88 |
| Romosozumab | Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius | Day 127 | -0.49 percent change | Standard Error 1.19 |
Secondary
Terminal Half-life (t1/2,z) 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: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Terminal Half-life (t1/2,z) of Romosozumab | 6.82 days | Standard Deviation 0.92 |
Secondary
Time to Maximum Serum 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: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Maximum Serum Concentration (Tmax) of Romosozumab | First dose | 3.0 days |
| Placebo | Time to Maximum Serum Concentration (Tmax) of Romosozumab | Last dose | 5.0 days |