Osteoporosis
Conditions
Keywords
Postmenopausal, Denosumab
Brief summary
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.
Interventions
DRUGPlacebo
Administered by subcutaneous injection
BIOLOGICALDenosumab
Administered by subcutaneous injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Healthy volunteers
No
Inclusion criteria
* ambulatory women between the ages of 40 and 64 years, inclusive * postmenopausal, defined as amenorrheic for at least 24 months * clinically acceptable physical exam * clinical laboratory tests (complete blood count \[CBC\], blood chemistries, urinalysis) within normal limits or clinically acceptable to the investigator/sponsor at the time of screening with the exception of aspartate transaminase (AST) and alkaline phosphatase (ALT), which must be \< 1.25 times the upper limit of normal, or gamma-glutamyl transpeptidase (GGT), which must be \< 1.5 times the upper limit of normal * normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting ventricular rate and PR, QRS, QT, and QTc intervals) * body mass index between 17 and 27 * willing to sign an approved informed consent form before any study-specific assessments and oral consultations are performed
Exclusion criteria
* administration of medications within 6 months before investigational product administration that are known to effect bone metabolism, including but not limited to the following: calcitonin, parathyroid hormone (or any derivative), supplemental vitamin D (\> 1000 IU/day), glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the date of informed consent were allowed), anabolic steroids, calcitriol and available analogues, diuretics * administration of the following medications within 12 months before study drug administration: bisphosphonates, fluoride for osteoporosis * diagnosed with any condition that affects bone metabolism * greatly differing levels of physical activity compared with the 6 months before investigational product administration or constant levels of intense physical activities * routine alcohol intake of ≥ 2 drinks/day, on average, within 6 months of investigational product administration * known sensitivity to any drugs * positive test results for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus antigen/antibody, syphilis * receiving or received any investigational drug (or was currently using an investigational device) within 4 months before receiving investigational product * donated any amount of blood within 16 weeks, or over 400 mL (Note: not 400 mL but 200 mL, for the subjects who were to be enrolled into cohorts 4 or 5) within 1 year of the start day of screening * subject had previously entered this study * any other condition that might have reduced the chance of obtaining data (eg, known poor compliance) required by the protocol or that might have compromised the ability to give truly informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab | Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts |
| Maximum Observed Concentration of Denosumab (Cmax) | Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts |
| Time to Maximum Observed Concentration (Tmax) of Denosumab | Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts |
| Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration | Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts |
| Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Baseline and day 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only). |
| Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Baseline and day 8, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, and 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only) |
| Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Baseline and day 2, 3, 5, 8, 15, 29, 57, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only) |
| Apparent Clearance (CL/F) of Denosumab | Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts |
Participant flow
Recruitment details
This study was conducted at one clinical center in Japan.
Pre-assignment details
The study consisted of 5 dose cohorts of 8 participants. Within each dose cohort 6 participants were randomly assigned to receive denosumab and 2 participants to receive placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a single subcutaneous injection of placebo to denosumab on day 1. | 12 |
| Denosumab 0.03 mg/kg Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1. | 6 |
| Denosumab 0.1 mg/kg Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1. | 6 |
| Denosumab 0.3 mg/kg Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1. | 8 |
| Denosumab 1.0 mg/kg Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1. | 7 |
| Denosumab 3.0 mg/kg Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1. | 6 |
| Total | 45 |
Baseline characteristics
| Characteristic | Placebo | Denosumab 0.03 mg/kg | Denosumab 0.1 mg/kg | Denosumab 0.3 mg/kg | Denosumab 1.0 mg/kg | Denosumab 3.0 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.83 years STANDARD_DEVIATION 2.86 | 59.67 years STANDARD_DEVIATION 2.34 | 59.50 years STANDARD_DEVIATION 3.39 | 58.88 years STANDARD_DEVIATION 3.8 | 56.43 years STANDARD_DEVIATION 3.95 | 58.67 years STANDARD_DEVIATION 2.34 | 58.91 years STANDARD_DEVIATION 3.22 |
| Race/Ethnicity, Customized Japanese | 12 Participants | 6 Participants | 6 Participants | 8 Participants | 7 Participants | 6 Participants | 45 Participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 6 Participants | 8 Participants | 7 Participants | 6 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 6 / 10 | 2 / 6 | 3 / 6 | 5 / 6 | 6 / 6 | 5 / 6 | 21 / 30 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 30 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events | Any adverse event | 6 Participants |
| Placebo | Number of Participants With Adverse Events | Treatment-related adverse events | 4 Participants |
| Placebo | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Deaths on study | 0 Participants |
| Denosumab 0.03 mg/kg | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Denosumab 0.03 mg/kg | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Denosumab 0.03 mg/kg | Number of Participants With Adverse Events | Treatment-related adverse events | 0 Participants |
| Denosumab 0.03 mg/kg | Number of Participants With Adverse Events | Any adverse event | 2 Participants |
| Denosumab 0.03 mg/kg | Number of Participants With Adverse Events | Deaths on study | 0 Participants |
| Denosumab 0.1 mg/kg | Number of Participants With Adverse Events | Any adverse event | 3 Participants |
| Denosumab 0.1 mg/kg | Number of Participants With Adverse Events | Deaths on study | 0 Participants |
| Denosumab 0.1 mg/kg | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Denosumab 0.1 mg/kg | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Denosumab 0.1 mg/kg | Number of Participants With Adverse Events | Treatment-related adverse events | 1 Participants |
| Denosumab 0.3 mg/kg | Number of Participants With Adverse Events | Treatment-related adverse events | 3 Participants |
| Denosumab 0.3 mg/kg | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Denosumab 0.3 mg/kg | Number of Participants With Adverse Events | Deaths on study | 0 Participants |
| Denosumab 0.3 mg/kg | Number of Participants With Adverse Events | Any adverse event | 5 Participants |
| Denosumab 0.3 mg/kg | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Denosumab 1.0 mg/kg | Number of Participants With Adverse Events | Any adverse event | 6 Participants |
| Denosumab 1.0 mg/kg | Number of Participants With Adverse Events | Treatment-related adverse events | 4 Participants |
| Denosumab 1.0 mg/kg | Number of Participants With Adverse Events | Deaths on study | 0 Participants |
| Denosumab 1.0 mg/kg | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Denosumab 1.0 mg/kg | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Denosumab 3.0 mg/kg | Number of Participants With Adverse Events | Deaths on study | 0 Participants |
| Denosumab 3.0 mg/kg | Number of Participants With Adverse Events | Discontinuation due to adverse events | 0 Participants |
| Denosumab 3.0 mg/kg | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Denosumab 3.0 mg/kg | Number of Participants With Adverse Events | Treatment-related adverse events | 4 Participants |
| Denosumab 3.0 mg/kg | Number of Participants With Adverse Events | Any adverse event | 5 Participants |
Secondary
Apparent Clearance (CL/F) of Denosumab
Time frame: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts
Population: All participants who received denosumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Apparent Clearance (CL/F) of Denosumab | 15.3 mL/day/kg | Standard Deviation 4.2 |
| Denosumab 0.03 mg/kg | Apparent Clearance (CL/F) of Denosumab | 8.31 mL/day/kg | Standard Deviation 4.97 |
| Denosumab 0.1 mg/kg | Apparent Clearance (CL/F) of Denosumab | 3.72 mL/day/kg | Standard Deviation 0.89 |
| Denosumab 0.3 mg/kg | Apparent Clearance (CL/F) of Denosumab | 2.20 mL/day/kg | Standard Deviation 0.56 |
| Denosumab 1.0 mg/kg | Apparent Clearance (CL/F) of Denosumab | 1.85 mL/day/kg | Standard Deviation 0.58 |
Secondary
Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab
Time frame: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts
Population: All participants who received denosumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab | 2.06 μg*day/mL | Standard Deviation 0.53 |
| Denosumab 0.03 mg/kg | Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab | 15.2 μg*day/mL | Standard Deviation 6.7 |
| Denosumab 0.1 mg/kg | Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab | 84.3 μg*day/mL | Standard Deviation 20.1 |
| Denosumab 0.3 mg/kg | Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab | 481 μg*day/mL | Standard Deviation 131 |
| Denosumab 1.0 mg/kg | Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab | 1790 μg*day/mL | Standard Deviation 650 |
Secondary
Maximum Observed Concentration of Denosumab (Cmax)
Time frame: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Concentration of Denosumab (Cmax) | 99.6 ng/mL | Standard Deviation 25.8 |
| Denosumab 0.03 mg/kg | Maximum Observed Concentration of Denosumab (Cmax) | 492 ng/mL | Standard Deviation 166 |
| Denosumab 0.1 mg/kg | Maximum Observed Concentration of Denosumab (Cmax) | 1910 ng/mL | Standard Deviation 658 |
| Denosumab 0.3 mg/kg | Maximum Observed Concentration of Denosumab (Cmax) | 8690 ng/mL | Standard Deviation 2170 |
| Denosumab 1.0 mg/kg | Maximum Observed Concentration of Denosumab (Cmax) | 27400 ng/mL | Standard Deviation 7880 |
Secondary
Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration
Time frame: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts
Population: All participants who received denosumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration | 15.5 days | Standard Deviation 4.7 |
| Denosumab 0.03 mg/kg | Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration | 22.5 days | Standard Deviation 3.9 |
| Denosumab 0.1 mg/kg | Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration | 33.6 days | Standard Deviation 5.8 |
| Denosumab 0.3 mg/kg | Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration | 42.6 days | Standard Deviation 7 |
| Denosumab 1.0 mg/kg | Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration | 51.4 days | Standard Deviation 5.8 |
Secondary
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Time frame: Baseline and day 8, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, and 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only)
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 169 | 3.1 percent change | Standard Error 4.3 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 85 | 1.3 percent change | Standard Error 2.2 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 197 | 8.6 percent change | Standard Error 5.8 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 141 | -0.2 percent change | Standard Error 4.9 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 113 | 3.1 percent change | Standard Error 2.3 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 99 | 1.7 percent change | Standard Error 3.2 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 71 | -0.9 percent change | Standard Error 3 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 253 | 11.7 percent change | Standard Error 6.5 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 57 | 2.7 percent change | Standard Error 1.6 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 29 | 5.3 percent change | Standard Error 2.9 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 43 | 3.6 percent change | Standard Error 3.1 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 225 | 4.6 percent change | Standard Error 3 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 22 | 1.1 percent change | Standard Error 2.8 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 15 | -2.1 percent change | Standard Error 1.4 |
| Placebo | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 8 | -0.4 percent change | Standard Error 2.8 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 57 | -5.9 percent change | Standard Error 5.1 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 43 | -2.3 percent change | Standard Error 2.8 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 85 | -7.9 percent change | Standard Error 6.3 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 8 | -6.9 percent change | Standard Error 5.9 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 15 | 1.1 percent change | Standard Error 3.1 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 22 | 12.7 percent change | Standard Error 3.1 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 29 | 8.9 percent change | Standard Error 3.6 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 71 | -5.5 percent change | Standard Error 4.8 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 99 | -13.1 percent change | Standard Error 3.3 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 113 | -0.5 percent change | Standard Error 7.1 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 22 | 5.8 percent change | Standard Error 2.3 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 71 | -29.0 percent change | Standard Error 5.7 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 8 | 16.6 percent change | Standard Error 4.7 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 99 | -33.4 percent change | Standard Error 5.5 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 113 | -32.6 percent change | Standard Error 5.4 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 57 | -19.2 percent change | Standard Error 2.8 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 29 | 11.0 percent change | Standard Error 3.5 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 15 | 8.6 percent change | Standard Error 2 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 169 | -33.9 percent change | Standard Error 7.8 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 225 | 19.5 percent change | — |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 43 | -7.6 percent change | Standard Error 4.3 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 85 | -27.2 percent change | Standard Error 6.1 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 99 | -49.4 percent change | Standard Error 3 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 281 | -10.7 percent change | Standard Error 6.1 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 43 | -20.3 percent change | Standard Error 3.2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 57 | -33.1 percent change | Standard Error 3.1 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 85 | -47.7 percent change | Standard Error 3.2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 71 | -41.0 percent change | Standard Error 2.2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 15 | 13.2 percent change | Standard Error 2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 8 | 7.1 percent change | Standard Error 2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 141 | -57.2 percent change | Standard Error 2.6 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 22 | 7.8 percent change | Standard Error 3.8 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 169 | -52.9 percent change | Standard Error 2.5 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 113 | -54.2 percent change | Standard Error 2.6 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 225 | -37.1 percent change | Standard Error 4.4 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 29 | -0.7 percent change | Standard Error 2.8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 169 | -50.1 percent change | Standard Error 4.6 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 8 | -0.5 percent change | Standard Error 5.1 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 43 | -10.2 percent change | Standard Error 4 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 15 | 5.6 percent change | Standard Error 5.9 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 22 | 7.0 percent change | Standard Error 5.3 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 29 | 5.8 percent change | Standard Error 4.2 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 309 | -21.0 percent change | Standard Error 14.7 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 57 | -21.0 percent change | Standard Error 4.9 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 197 | -43.9 percent change | Standard Error 8.6 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 85 | -42.1 percent change | Standard Error 4.2 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 253 | -31.9 percent change | Standard Error 9.7 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 99 | -44.0 percent change | Standard Error 5.5 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 113 | -49.7 percent change | Standard Error 5.1 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 225 | -35.1 percent change | Standard Error 8.5 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 141 | -50.7 percent change | Standard Error 6.9 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 71 | -36.1 percent change | Standard Error 5.2 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 15 | 11.5 percent change | Standard Error 7.8 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 99 | -47.5 percent change | Standard Error 2.7 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 225 | -48.4 percent change | Standard Error 3.6 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 29 | -0.4 percent change | Standard Error 4.5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 309 | -26.8 percent change | Standard Error 4.8 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 22 | 9.7 percent change | Standard Error 5.8 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 8 | 3.1 percent change | Standard Error 6.4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 113 | -51.4 percent change | Standard Error 2.6 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 71 | -33.9 percent change | Standard Error 4.7 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 253 | -44.0 percent change | Standard Error 4.1 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 141 | -52.9 percent change | Standard Error 3.8 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 85 | -43.9 percent change | Standard Error 1.9 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 169 | -53.7 percent change | Standard Error 2.9 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 197 | -52.5 percent change | Standard Error 2.7 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 57 | -24.0 percent change | Standard Error 2.6 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) | Day 43 | -14.7 percent change | Standard Error 2.6 |
Secondary
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Time frame: Baseline and day 2, 3, 5, 8, 15, 29, 57, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only)
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 5.6 percent change | Standard Error 7.4 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 17.1 percent change | Standard Error 10.2 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 5.3 percent change | Standard Error 8.3 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 3 | -8.2 percent change | Standard Error 6.1 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 6.9 percent change | Standard Error 8.7 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 5 | -3.9 percent change | Standard Error 6 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | -1.2 percent change | Standard Error 10.2 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 253 | 8.5 percent change | Standard Error 12.6 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | -0.7 percent change | Standard Error 8.9 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 5.1 percent change | Standard Error 7.7 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 225 | -5.1 percent change | Standard Error 14.1 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 197 | -14.9 percent change | Standard Error 5.4 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | -7.9 percent change | Standard Error 5.3 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | -3.8 percent change | Standard Error 13.9 |
| Placebo | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 11.2 percent change | Standard Error 8.9 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 3 | 28.9 percent change | Standard Error 9.7 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 5 | 47.6 percent change | Standard Error 12.2 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 37.7 percent change | Standard Error 20.4 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 64.6 percent change | Standard Error 18.4 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 11.9 percent change | Standard Error 9.6 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 19.9 percent change | Standard Error 10.5 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 2.4 percent change | Standard Error 13 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 91.5 percent change | Standard Error 8.2 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 97.2 percent change | Standard Error 23.8 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 3.9 percent change | Standard Error 15.4 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 46.4 percent change | Standard Error 31.1 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 117.3 percent change | Standard Error 33.4 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 3 | 15.0 percent change | Standard Error 18.8 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | -16.7 percent change | Standard Error 10.6 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 29.5 percent change | Standard Error 32.8 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 110.9 percent change | Standard Error 40.7 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 36.6 percent change | Standard Error 24.5 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 120.5 percent change | Standard Error 35.5 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 10.1 percent change | Standard Error 14.1 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 5 | 51.8 percent change | Standard Error 17.9 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 76.9 percent change | Standard Error 20.7 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 225 | 15.9 percent change | — |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 99.2 percent change | Standard Error 16.8 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 5 | 114.2 percent change | Standard Error 27.2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | 16.9 percent change | Standard Error 11.1 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 44.0 percent change | Standard Error 13 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 281 | -26.1 percent change | Standard Error 9.4 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 79.6 percent change | Standard Error 13.9 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 3 | 71.7 percent change | Standard Error 15.8 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 146.4 percent change | Standard Error 29 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 225 | -30.9 percent change | Standard Error 5 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 76.9 percent change | Standard Error 20.2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | 19.7 percent change | Standard Error 8.2 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 98.0 percent change | Standard Error 17.9 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 38.5 percent change | Standard Error 13.5 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 182.4 percent change | Standard Error 40.2 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 197 | 17.0 percent change | Standard Error 9.8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 64.4 percent change | Standard Error 18.4 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 44.0 percent change | Standard Error 10.9 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | 22.8 percent change | Standard Error 16.6 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 163.7 percent change | Standard Error 38.4 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | 21.9 percent change | Standard Error 16.1 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 225 | 6.2 percent change | Standard Error 12.3 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 253 | 10.9 percent change | Standard Error 18.1 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 309 | 16.6 percent change | Standard Error 24.9 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 40.9 percent change | Standard Error 19.5 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 3 | 60.7 percent change | Standard Error 21.7 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 5 | 103.1 percent change | Standard Error 41.8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 109.4 percent change | Standard Error 36.3 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 70.4 percent change | Standard Error 28.3 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 46.5 percent change | Standard Error 10.5 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 90.9 percent change | Standard Error 20.8 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 225 | 151.4 percent change | Standard Error 83.5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 197 | 100.7 percent change | Standard Error 42.1 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 57 | 177.0 percent change | Standard Error 36.8 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 169 | 90.2 percent change | Standard Error 27.6 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 141 | 175.4 percent change | Standard Error 81.3 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 8 | 353.6 percent change | Standard Error 92.4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 113 | 155.7 percent change | Standard Error 44.5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 15 | 203.2 percent change | Standard Error 27.2 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 99 | 178.5 percent change | Standard Error 93.3 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 3 | 146.1 percent change | Standard Error 46 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 309 | 33.8 percent change | Standard Error 11.9 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 253 | 70.8 percent change | Standard Error 31.5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 5 | 262.1 percent change | Standard Error 61.9 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 29 | 215.2 percent change | Standard Error 79.4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 2 | 129.0 percent change | Standard Error 25.2 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Day 85 | 170.5 percent change | Standard Error 40.8 |
Secondary
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Time frame: Baseline and day 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only).
Population: Treated participants with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 22 | -1 percent change | Standard Error 5 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 141 | -7 percent change | Standard Error 9 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 113 | -5 percent change | Standard Error 6 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 3 | 19 percent change | Standard Error 5 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 57 | 0 percent change | Standard Error 8 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 85 | 8 percent change | Standard Error 7 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 99 | 1 percent change | Standard Error 6 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 4 | 7 percent change | Standard Error 6 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 197 | -3 percent change | Standard Error 5 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 253 | -13 percent change | Standard Error 10 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 11 | 3 percent change | Standard Error 8 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 29 | -1 percent change | Standard Error 5 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 8 | 16 percent change | Standard Error 7 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 169 | -15 percent change | Standard Error 6 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 225 | -7 percent change | Standard Error 11 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 6 | 9 percent change | Standard Error 7 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 15 | 4 percent change | Standard Error 3 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 71 | -5 percent change | Standard Error 7 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 2 | 12 percent change | Standard Error 11 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 43 | -1 percent change | Standard Error 5 |
| Placebo | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 5 | 23 percent change | Standard Error 10 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 15 | -51 percent change | Standard Error 4 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 43 | -33 percent change | Standard Error 6 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 22 | -41 percent change | Standard Error 4 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 29 | -39 percent change | Standard Error 5 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 2 | 6 percent change | Standard Error 4 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 11 | -36 percent change | Standard Error 5 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 113 | 3 percent change | Standard Error 4 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 3 | -6 percent change | Standard Error 7 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 85 | 4 percent change | Standard Error 8 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 4 | -18 percent change | Standard Error 9 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 5 | -12 percent change | Standard Error 12 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 99 | 4 percent change | Standard Error 6 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 71 | -23 percent change | Standard Error 6 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 6 | -1 percent change | Standard Error 18 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 57 | -14 percent change | Standard Error 3 |
| Denosumab 0.03 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 8 | -12 percent change | Standard Error 13 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 11 | -67 percent change | Standard Error 5 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 5 | -44 percent change | Standard Error 5 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 8 | -55 percent change | Standard Error 7 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 29 | -68 percent change | Standard Error 3 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 113 | -30 percent change | Standard Error 15 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 225 | 42.0 percent change | — |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 22 | -71 percent change | Standard Error 6 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 6 | -53 percent change | Standard Error 8 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 99 | -37 percent change | Standard Error 15 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 57 | -59 percent change | Standard Error 6 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 43 | -67 percent change | Standard Error 4 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 85 | -48 percent change | Standard Error 12 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 169 | 6 percent change | Standard Error 14 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 4 | -37 percent change | Standard Error 16 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 15 | -68 percent change | Standard Error 4 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 3 | -30 percent change | Standard Error 5 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 71 | -48 percent change | Standard Error 10 |
| Denosumab 0.1 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 2 | -25 percent change | Standard Error 8 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 6 | -62 percent change | Standard Error 7 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 99 | -64 percent change | Standard Error 5 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 141 | -51 percent change | Standard Error 5 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 225 | -30 percent change | Standard Error 4 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 2 | -22 percent change | Standard Error 11 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 3 | -40 percent change | Standard Error 11 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 4 | -48 percent change | Standard Error 11 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 5 | -51 percent change | Standard Error 8 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 11 | -65 percent change | Standard Error 7 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 8 | -64 percent change | Standard Error 5 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 15 | -71 percent change | Standard Error 5 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 22 | -70 percent change | Standard Error 7 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 29 | -67 percent change | Standard Error 6 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 43 | -68 percent change | Standard Error 7 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 57 | -64 percent change | Standard Error 8 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 71 | -65 percent change | Standard Error 6 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 85 | -58 percent change | Standard Error 9 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 113 | -53 percent change | Standard Error 10 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 169 | -41 percent change | Standard Error 11 |
| Denosumab 0.3 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 281 | -13 percent change | Standard Error 8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 5 | -53 percent change | Standard Error 8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 43 | -69 percent change | Standard Error 8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 8 | -57 percent change | Standard Error 7 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 6 | -59 percent change | Standard Error 6 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 11 | -69 percent change | Standard Error 6 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 57 | -56 percent change | Standard Error 10 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 253 | -25 percent change | Standard Error 14 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 71 | -68 percent change | Standard Error 5 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 4 | -55 percent change | Standard Error 6 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 3 | -51 percent change | Standard Error 8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 85 | -68 percent change | Standard Error 4 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 99 | -72 percent change | Standard Error 4 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 2 | -40 percent change | Standard Error 7 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 225 | -20 percent change | Standard Error 17 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 113 | -77 percent change | Standard Error 3 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 141 | -62 percent change | Standard Error 5 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 309 | -19 percent change | Standard Error 13 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 169 | -48 percent change | Standard Error 9 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 197 | -47 percent change | Standard Error 8 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 22 | -70 percent change | Standard Error 5 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 29 | -64 percent change | Standard Error 7 |
| Denosumab 1.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 15 | -71 percent change | Standard Error 5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 99 | -77 percent change | Standard Error 10 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 2 | -64 percent change | Standard Error 4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 43 | -81 percent change | Standard Error 4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 11 | -79 percent change | Standard Error 3 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 6 | -72 percent change | Standard Error 4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 29 | -77 percent change | Standard Error 4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 309 | -23 percent change | Standard Error 12 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 22 | -82 percent change | Standard Error 3 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 57 | -79 percent change | Standard Error 6 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 5 | -66 percent change | Standard Error 6 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 225 | -70 percent change | Standard Error 4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 4 | -62 percent change | Standard Error 5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 113 | -84 percent change | Standard Error 2 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 141 | -81 percent change | Standard Error 3 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 71 | -82 percent change | Standard Error 3 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 15 | -77 percent change | Standard Error 5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 3 | -60 percent change | Standard Error 3 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 197 | -79 percent change | Standard Error 4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 253 | -62 percent change | Standard Error 5 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 8 | -64 percent change | Standard Error 10 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 85 | -83 percent change | Standard Error 4 |
| Denosumab 3.0 mg/kg | Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr) | Day 169 | -78 percent change | Standard Error 5 |
Secondary
Time to Maximum Observed Concentration (Tmax) of Denosumab
Time frame: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts
Population: All participants who received denosumab
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Maximum Observed Concentration (Tmax) of Denosumab | 7.0 days |
| Denosumab 0.03 mg/kg | Time to Maximum Observed Concentration (Tmax) of Denosumab | 12.0 days |
| Denosumab 0.1 mg/kg | Time to Maximum Observed Concentration (Tmax) of Denosumab | 14.0 days |
| Denosumab 0.3 mg/kg | Time to Maximum Observed Concentration (Tmax) of Denosumab | 14.0 days |
| Denosumab 1.0 mg/kg | Time to Maximum Observed Concentration (Tmax) of Denosumab | 14.0 days |