A Phase 1 interventional study of Romosozumab and Placebo in Postmenopausal and Osteopenia, sponsored by Amgen. Completed. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.
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Exclusion Criteria:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months.
Drug: Placebo
Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, or 3 mg/kg Q4W for 3 months.
Drug: Romosozumab
Administered by subcutaneous injection
Also known as: AMG 785, EVENITY™
Administered by subcutaneous injection
Number of Participants With Adverse Events
Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?'
Time frame: 169 days
Number of Participants Who Developed Antibodies to Romosozumab
All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing. Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline.
Time frame: Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169.
Time to Maximum Observed Concentration (Tmax) of Romosozumab
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Maximum Observed Concentration (Cmax) of Romosozumab
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab
Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts)
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab
Time frame: Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169.
Accumulation Ratio (AR) for Romosozumab
The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose.
Time frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Percent Change From Baseline in Bone Mineral Density of the Total Spine
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Total Hip
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Femoral Hip
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density of the Whole Body
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time frame: Baseline and days 29, 85, 127, and 169
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Percent Change From Baseline in Osteocalcin
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Time frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Percent Change From Baseline in Sclerostin
Time frame: Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169
Change From Baseline in Ionized Calcium
Time frame: Baseline and day 169 (or earlier for participants who discontinued before day 169)
This study was conducted at 4 centers in the United States (US) from 14 November 2007 to 2 December 2008.
| Milestone | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Started | 12 | 6 | 6 | 6 | 6 | 6 | 6 |
| Completed | 12 | 6 | 6 | 6 | 4 | 5 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?'
| Participants | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Any adverse event | 10 | 6 | 6 | 6 | 5 | 5 | 5 |
| Serious adverse events | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Treatment-related adverse events | 6 | 1 | 1 | 4 | 3 | 3 | 2 |
| Treatment-related serious adverse events | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to adverse events | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Death on study | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing. Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline.
| Participants | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Binding antibodies | 0 | 2 | 2 | 2 | 3 | 1 | 3 |
| Neutralizing antibodies | 0 | 1 | 1 | 0 | 0 | 0 | 1 |
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL.
| days | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|
| First dose | 3.0 (2.0 to 5.0) | 3.0 (3.0 to 5.0) | 4.5 (3.0 to 7.0) | 3.0 (3.0 to 5.0) | 3.0 (3.0 to 5.0) | 5.0 (3.0 to 5.0) |
| Last dose | 3.0 (3.0 to 5.0) | 3.0 (1.0 to 4.0) | 3.5 (3.0 to 5.0) | 5.0 (2.0 to 7.0) | 3.0 (3.0 to 5.0) | 3.0 (3.0 to 5.0) |
| μg/mL | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|
| First dose | 6.80 ± 1.86 | 15.7 ± 4.6 | 14.8 ± 6.0 | 24.5 ± 6.8 | 8.06 ± 1.57 | 27.7 ± 4.2 |
| Last dose | 14.2 ± 4.3 | 16.7 ± 3.3 | 27.8 ± 8.4 | 29.5 ± 8.7 | 13.4 ± 4.4 | 37.1 ± 8.1 |
Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts)
| μg*day/mL | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|
| First dose | 65.5 ± 15.6 | 202 ± 48 | 152 ± 63 | 340 ± 73 | 71.3 ± 11.8 | 434 ± 81 |
| Last dose | 141 ± 41 | 231 ± 58 | 321 ± 97 | 462 ± 97 | 136 ± 42 | 555 ± 181 |
| days | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|
| Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | 7.02 ± 3.52 | 6.51 ± 1.37 | 9.32 ± 1.88 | 6.84 ± 1.79 | 6.77 ± 1.92 | 6.07 ± 1.50 |
The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose.
| ratio | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|
| Accumulation Ratio (AR) for Romosozumab | 2.15 ± 0.45 | 1.17 ± 0.26 | 2.35 ± 0.90 | 1.35 ± 0.19 | 1.90 ± 0.49 | 1.26 ± 0.23 |
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab.
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 29 | -0.046 ± 0.778 | 2.161 ± 0.177 | 0.541 ± 1.296 | -0.495 ± 0.930 | -0.257 ± 0.623 | 2.662 ± 0.804 | -0.660 ± 1.240 |
| Day 85 | -0.843 ± 0.829 | 3.579 ± 1.942 | 3.881 ± 1.437 | 3.853 ± 0.543 | 3.146 ± 2.027 | 3.135 ± 1.085 | 4.157 ± 0.714 |
| Day 127 | 0.177 ± 0.907 | 4.313 ± 3.057 | 7.219 ± 1.243 | 6.350 ± 0.732 | 5.566 ± 2.142 | 4.462 ± 1.787 | 5.599 ± 0.756 |
| Day 169 | -0.559 ± 1.013 | 4.769 ± 1.916 | 4.835 ± 1.116 | 5.250 ± 1.630 | 4.980 ± 2.111 | 5.187 ± 0.825 | 6.560 ± 1.293 |
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 29 | -0.552 ± 0.347 | 0.528 ± 0.617 | -0.768 ± 0.334 | 0.112 ± 0.940 | -0.318 ± 1.182 | 1.244 ± 1.368 | -0.902 ± 0.408 |
| Day 85 | -0.613 ± 0.529 | 1.066 ± 0.938 | 0.639 ± 0.608 | 2.116 ± 0.477 | 2.088 ± 0.550 | 1.134 ± 0.797 | 0.731 ± 0.621 |
| Day 127 | -0.793 ± 0.623 | 0.702 ± 1.180 | 0.621 ± 0.940 | 2.855 ± 0.778 | 3.996 ± 1.109 | 2.111 ± 0.486 | 1.455 ± 0.669 |
| Day 169 | -0.511 ± 0.380 | 1.423 ± 1.047 | 0.894 ± 1.013 | 3.176 ± 1.105 | 2.094 ± 0.751 | 1.007 ± 0.422 | 0.370 ± 0.629 |
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 29 | -0.394 ± 0.573 | 0.300 ± 0.813 | -2.172 ± 1.331 | -0.811 ± 1.596 | -0.473 ± 1.987 | 0.471 ± 1.919 | -0.597 ± 0.839 |
| Day 85 | -1.175 ± 1.042 | 1.360 ± 1.031 | 0.578 ± 1.285 | -0.123 ± 1.001 | 0.270 ± 1.176 | 1.301 ± 0.681 | 1.956 ± 1.493 |
| Day 127 | -2.301 ± 0.745 | 1.284 ± 1.255 | -1.005 ± 2.609 | 1.471 ± 1.228 | 1.332 ± 2.488 | 1.861 ± 1.208 | 0.091 ± 1.110 |
| Day 169 | -0.447 ± 0.673 | 0.801 ± 1.208 | -0.672 ± 1.783 | 0.510 ± 1.103 | 2.197 ± 1.674 | 1.665 ± 1.582 | 0.116 ± 2.003 |
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 29 | 1.676 ± 0.897 | -0.220 ± 0.998 | -0.900 ± 0.733 | -2.052 ± 1.295 | -2.968 ± 0.930 | -0.435 ± 1.078 | -1.185 ± 1.101 |
| Day 85 | 0.609 ± 0.943 | -0.082 ± 1.012 | -2.740 ± 0.770 | 0.803 ± 1.411 | -4.125 ± 0.421 | -2.504 ± 1.777 | -0.993 ± 1.478 |
| Day 127 | 0.835 ± 0.988 | 0.680 ± 1.345 | -1.037 ± 0.668 | 0.633 ± 1.450 | -4.739 ± 0.642 | -1.756 ± 1.158 | -2.263 ± 1.227 |
| Day 169 | -0.191 ± 0.753 | 0.522 ± 1.835 | 0.240 ± 1.068 | -0.028 ± 1.943 | -3.647 ± 0.924 | -1.836 ± 1.145 | -1.449 ± 1.106 |
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 29 | 0.135 ± 0.529 | -0.552 ± 1.134 | -0.014 ± 0.591 | -0.020 ± 0.944 | -0.438 ± 1.054 | 0.757 ± 0.698 | 0.021 ± 0.479 |
| Day 85 | 0.329 ± 0.604 | -0.063 ± 1.269 | -0.754 ± 0.533 | 0.448 ± 0.549 | -3.621 ± 1.424 | -0.306 ± 0.510 | 0.160 ± 0.296 |
| Day 127 | 0.236 ± 0.563 | -1.134 ± 1.388 | 0.493 ± 0.792 | -0.739 ± 0.595 | -3.326 ± 1.895 | -0.914 ± 0.338 | -1.019 ± 0.647 |
| Day 169 | 0.417 ± 0.768 | -1.102 ± 1.834 | -0.928 ± 0.717 | -0.234 ± 1.126 | -2.632 ± 1.466 | -0.378 ± 0.818 | -0.211 ± 0.619 |
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 29 | -0.391 ± 0.347 | 0.493 ± 0.580 | -1.122 ± 0.885 | -0.532 ± 0.188 | 0.521 ± 0.567 | -0.058 ± 0.387 | -0.611 ± 0.344 |
| Day 85 | 0.103 ± 0.391 | 0.259 ± 0.642 | -0.324 ± 0.827 | 1.359 ± 0.276 | -0.151 ± 0.614 | 0.459 ± 0.271 | 0.243 ± 0.447 |
| Day 127 | 0.000 ± 0.371 | -1.068 ± 0.357 | -0.486 ± 0.938 | 1.442 ± 0.862 | 0.513 ± 0.600 | 1.919 ± 0.839 | 0.012 ± 0.562 |
| Day 169 | -0.352 ± 0.320 | 0.180 ± 1.143 | -0.294 ± 0.597 | 1.284 ± 0.637 | 0.801 ± 0.523 | 1.285 ± 0.264 | 0.218 ± 0.819 |
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 2 | -4.55 ± 3.83 | 5.90 ± 4.97 | 4.37 ± 3.98 | 1.18 ± 4.35 | -0.71 ± 3.94 | 8.46 ± 6.50 | -0.64 ± 13.43 |
| Day 4 | 0.81 ± 3.92 | 14.72 ± 5.61 | 16.32 ± 6.77 | 7.99 ± 10.60 | 9.53 ± 9.47 | 15.32 ± 7.40 | 10.72 ± 15.27 |
| Day 6 | -5.99 ± 4.33 | 46.69 ± 7.59 | 32.85 ± 7.41 | 23.19 ± 10.40 | 32.18 ± 4.75 | 27.78 ± 7.72 | 33.83 ± 19.09 |
| Day 8 | -1.65 ± 5.47 | 45.25 ± 8.02 | 37.14 ± 11.60 | 42.17 ± 3.90 | 69.31 ± 5.50 | 47.44 ± 12.82 | 70.63 ± 24.65 |
| Day 15 | -0.87 ± 6.06 | 58.03 ± 11.52 | 66.12 ± 14.63 | 76.66 ± 21.28 | 103.66 ± 7.37 | 58.81 ± 12.45 | 123.92 ± 39.13 |
| Day 22 | 0.20 ± 5.41 | 82.97 ± 21.49 | 53.76 ± 19.99 | 107.88 ± 19.52 | 117.63 ± 9.76 | 96.08 ± 13.47 | 142.64 ± 34.70 |
| Day 29 | -0.36 ± 5.54 | 81.45 ± 20.35 | 26.35 ± 10.41 | 118.17 ± 17.03 | 74.50 ± 16.33 | 88.21 ± 11.96 | 115.09 ± 26.83 |
| Day 36 | 5.42 ± 5.56 | 78.03 ± 21.98 | 59.50 ± 21.56 | 140.47 ± 17.70 | 103.87 ± 22.54 | 105.96 ± 14.87 | 147.40 ± 32.52 |
| Day 43 | 2.97 ± 5.73 | 69.94 ± 20.47 | 62.16 ± 23.95 | 93.15 ± 20.34 | 129.43 ± 21.06 | 98.49 ± 17.18 | 139.62 ± 31.52 |
| Day 50 | -12.20 ± 5.65 | 73.72 ± 23.57 | — | 128.64 ± 16.55 | — | 86.45 ± 14.88 | — |
| Day 57 | 1.74 ± 5.20 | 51.66 ± 20.71 | 3.28 ± 10.72 | 95.15 ± 21.45 | 77.00 ± 20.31 | 76.98 ± 12.12 | 74.16 ± 19.64 |
| Day 58 | 12.47 ± 6.76 | — | -7.77 ± 9.58 | — | 54.04 ± 16.51 | — | 82.95 ± 20.45 |
| Day 60 | 3.74 ± 5.80 | — | 0.47 ± 5.66 | — | 61.32 ± 17.08 | — | 85.82 ± 19.44 |
| Day 62 | 5.62 ± 2.62 | — | 11.85 ± 9.79 | — | 64.38 ± 8.62 | — | 94.88 ± 12.29 |
| Day 64 | 12.70 ± 12.29 | 49.88 ± 14.11 | 10.92 ± 11.34 | 65.34 ± 19.45 | 89.15 ± 12.34 | 68.67 ± 11.96 | 113.79 ± 18.18 |
| Day 71 | 0.11 ± 2.87 | 51.25 ± 15.27 | 20.01 ± 13.17 | 88.47 ± 15.08 | 64.99 ± 21.83 | 60.58 ± 14.65 | 113.62 ± 19.09 |
| Day 72 | -2.97 ± 4.13 | 32.99 ± 14.43 | — | 71.55 ± 7.88 | — | 63.76 ± 15.42 | — |
| Day 74 | -11.52 ± 6.52 | 49.16 ± 15.59 | — | 89.11 ± 15.49 | — | 71.99 ± 11.10 | — |
| Day 76 | -5.50 ± 6.48 | 45.95 ± 18.18 | — | 100.22 ± 18.29 | — | 78.57 ± 13.74 | — |
| Day 78 | 2.61 ± 5.24 | 51.59 ± 18.64 | 1.29 ± 11.31 | 77.58 ± 19.98 | 49.94 ± 17.55 | 75.17 ± 23.08 | 65.32 ± 13.57 |
| Day 85 | -2.40 ± 3.78 | 35.64 ± 11.54 | -3.90 ± 10.10 | 79.77 ± 20.53 | 24.94 ± 9.30 | 54.06 ± 11.05 | 44.44 ± 22.42 |
| Day 99 | -1.01 ± 4.04 | 3.21 ± 8.94 | -16.47 ± 8.68 | 31.38 ± 18.42 | -5.07 ± 13.01 | 14.97 ± 8.53 | 12.17 ± 16.53 |
| Day 113 | 3.39 ± 5.36 | 5.15 ± 8.34 | -14.06 ± 8.68 | -4.43 ± 9.13 | -9.38 ± 12.06 | -0.83 ± 9.20 | -7.13 ± 11.60 |
| Day 127 | 5.21 ± 6.81 | -3.26 ± 6.94 | -8.76 ± 9.73 | -9.51 ± 10.10 | -0.76 ± 17.80 | -7.63 ± 7.01 | -5.88 ± 9.47 |
| Day 141 | 4.35 ± 4.72 | -5.75 ± 5.62 | -19.84 ± 7.87 | 2.88 ± 10.84 | 22.42 ± 16.17 | -12.85 ± 12.79 | -9.24 ± 8.87 |
| Day 155 | 5.71 ± 4.91 | -5.45 ± 6.57 | -19.92 ± 9.17 | -0.73 ± 8.70 | 5.49 ± 22.07 | 1.76 ± 10.00 | -6.88 ± 9.24 |
| Day 169 | 7.58 ± 7.52 | 4.79 ± 7.31 | -16.91 ± 7.34 | 1.42 ± 6.81 | 11.67 ± 11.51 | 5.78 ± 9.42 | -7.07 ± 10.52 |
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 2 | -0.19 ± 2.81 | 6.61 ± 2.18 | -7.02 ± 4.56 | 4.95 ± 4.34 | -4.09 ± 6.71 | 9.53 ± 3.94 | -4.69 ± 5.12 |
| Day 4 | -3.07 ± 2.54 | 1.17 ± 6.38 | -13.51 ± 1.88 | -21.97 ± 5.50 | 6.66 ± 6.63 | 9.13 ± 17.95 | -9.27 ± 2.61 |
| Day 6 | -4.74 ± 2.91 | -5.55 ± 6.37 | -14.09 ± 5.65 | -0.71 ± 6.79 | 11.34 ± 6.43 | 16.14 ± 13.24 | -2.00 ± 3.09 |
| Day 8 | -3.68 ± 3.16 | -7.13 ± 3.83 | -4.14 ± 6.29 | 22.82 ± 5.24 | 41.85 ± 29.46 | 17.92 ± 8.35 | -2.77 ± 4.06 |
| Day 15 | -0.15 ± 2.34 | 23.55 ± 10.75 | 21.18 ± 6.94 | 33.18 ± 9.05 | 70.19 ± 15.1 | 45.22 ± 13.53 | 24.73 ± 5.35 |
| Day 22 | -4.19 ± 2.06 | 29.99 ± 8.26 | 34.90 ± 16.55 | 57.55 ± 11.24 | 84.14 ± 12.09 | 61.18 ± 19.45 | 64.18 ± 10.17 |
| Day 29 | 0.02 ± 2.67 | 49.44 ± 16.03 | 39.52 ± 11.33 | 81.71 ± 19.20 | 90.08 ± 7.79 | 55.58 ± 10.40 | 79.45 ± 17.12 |
| Day 36 | 3.54 ± 2.61 | 48.91 ± 10.93 | 35.29 ± 9.36 | 76.70 ± 12.51 | 87.21 ± 16.45 | 35.55 ± 12.53 | 68.03 ± 8.81 |
| Day 43 | 1.20 ± 2.85 | 45.46 ± 12.44 | 30.75 ± 14.39 | 77.15 ± 14.86 | 90.14 ± 17.06 | 57.62 ± 13.39 | 82.02 ± 14.92 |
| Day 50 | 0.92 ± 5.00 | 48.63 ± 13.20 | — | 89.23 ± 18.31 | — | 52.53 ± 19.49 | — |
| Day 57 | 4.07 ± 2.05 | 49.28 ± 10.45 | -0.80 ± 15.19 | 70.82 ± 16.48 | 74.73 ± 8.81 | 69.16 ± 19.15 | 81.16 ± 16.26 |
| Day 58 | 7.56 ± 5.24 | — | 8.12 ± 11.58 | — | 75.01 ± 14.15 | — | 75.70 ± 20.03 |
| Day 60 | 0.77 ± 5.59 | — | 3.28 ± 11.15 | — | 61.68 ± 9.37 | — | 57.90 ± 19.58 |
| Day 62 | 14.12 ± 3.88 | — | 2.04 ± 9.84 | — | 67.70 ± 12.26 | — | 47.72 ± 17.80 |
| Day 64 | 6.99 ± 4.49 | 27.01 ± 9.96 | 0.57 ± 10.33 | 60.91 ± 11.91 | 70.63 ± 10.99 | 50.40 ± 22.63 | 68.64 ± 16.90 |
| Day 71 | 1.87 ± 3.02 | 39.49 ± 12.97 | 27.96 ± 11.89 | 81.01 ± 20.69 | 77.51 ± 7.93 | 51.69 ± 16.41 | 79.70 ± 19.98 |
| Day 72 | 5.04 ± 5.29 | 32.17 ± 9.97 | — | 95.28 ± 20.14 | — | 63.00 ± 13.12 | — |
| Day 74 | -5.91 ± 2.36 | 31.72 ± 10.55 | — | 60.58 ± 13.97 | — | 52.83 ± 12.14 | — |
| Day 76 | -4.13 ± 7.92 | 36.41 ± 9.63 | — | 49.94 ± 3.93 | — | 60.11 ± 16.94 | — |
| Day 78 | -3.86 ± 3.35 | 29.10 ± 8.42 | 12.60 ± 11.10 | 74.99 ± 13.37 | 85.53 ± 15.09 | 56.10 ± 19.30 | 89.23 ± 23.86 |
| Day 85 | -4.37 ± 3.11 | 41.36 ± 11.92 | 19.11 ± 9.44 | 63.71 ± 11.99 | 77.23 ± 16.82 | 48.66 ± 12.49 | 81.93 ± 31.34 |
| Day 99 | -4.97 ± 3.94 | 21.81 ± 7.95 | -9.45 ± 6.47 | 49.49 ± 16.14 | 31.98 ± 6.31 | 33.70 ± 18.41 | 30.28 ± 26.45 |
| Day 113 | 2.57 ± 4.85 | 4.81 ± 8.41 | -11.70 ± 6.94 | 31.46 ± 10.14 | 20.24 ± 15.41 | 12.25 ± 12.11 | 6.17 ± 10.83 |
| Day 127 | -0.34 ± 4.46 | 2.79 ± 13.64 | -13.58 ± 4.48 | 24.45 ± 15.36 | 152.92 ± 144.30 | 5.06 ± 14.88 | -3.88 ± 11.30 |
| Day 141 | -3.80 ± 3.25 | -2.99 ± 8.22 | -25.33 ± 10.05 | 21.63 ± 8.86 | 17.25 ± 9.58 | 8.58 ± 9.20 | -4.33 ± 7.28 |
| Day 155 | -3.51 ± 4.78 | -6.23 ± 7.52 | -21.04 ± 7.35 | 7.69 ± 8.01 | 6.85 ± 14.51 | -7.10 ± 10.56 | -11.15 ± 14.79 |
| Day 169 | 1.25 ± 5.30 | -7.12 ± 7.84 | -20.27 ± 8.66 | 16.81 ± 12.43 | 24.60 ± 12.75 | 2.19 ± 10.84 | -13.66 ± 10.56 |
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 2 | -0.07 ± 2.80 | -4.51 ± 3.09 | -8.52 ± 3.73 | 10.25 ± 3.50 | 2.22 ± 4.04 | 5.82 ± 2.73 | -0.80 ± 4.20 |
| Day 4 | 2.16 ± 3.11 | -2.74 ± 4.96 | -4.52 ± 7.52 | 13.74 ± 3.39 | 1.15 ± 6.14 | 8.29 ± 6.28 | 6.68 ± 3.66 |
| Day 6 | 2.26 ± 3.85 | 11.82 ± 7.95 | 7.76 ± 3.93 | 14.17 ± 2.52 | 12.59 ± 4.56 | 3.64 ± 6.40 | 6.93 ± 1.29 |
| Day 8 | -3.30 ± 5.72 | 20.02 ± 10.24 | 9.69 ± 4.75 | 21.51 ± 6.34 | 21.87 ± 9.57 | 24.20 ± 14.92 | 20.98 ± 2.05 |
| Day 15 | -3.26 ± 3.45 | 31.67 ± 14.36 | 31.96 ± 6.28 | 33.68 ± 8.61 | 51.97 ± 5.28 | 15.58 ± 4.69 | 46.38 ± 8.63 |
| Day 22 | 1.23 ± 3.14 | 39.83 ± 11.04 | 37.30 ± 4.15 | 58.45 ± 14.40 | 57.66 ± 9.91 | 27.74 ± 7.34 | 61.39 ± 14.64 |
| Day 29 | -2.04 ± 2.94 | 56.09 ± 19.29 | 36.50 ± 8.85 | 65.10 ± 14.72 | 61.66 ± 13.21 | 36.74 ± 10.53 | 35.63 ± 13.78 |
| Day 36 | 0.04 ± 3.62 | 54.87 ± 14.40 | 28.89 ± 7.65 | 72.39 ± 12.18 | 63.55 ± 10.27 | 43.48 ± 7.98 | 34.27 ± 7.92 |
| Day 43 | -1.93 ± 5.02 | 49.26 ± 14.03 | 39.33 ± 10.46 | 68.54 ± 12.84 | 66.74 ± 10.38 | 27.55 ± 8.68 | 52.27 ± 13.48 |
| Day 50 | -5.81 ± 4.23 | 45.38 ± 15.81 | — | 68.67 ± 11.00 | — | 34.97 ± 10.37 | — |
| Day 57 | -2.15 ± 5.99 | 41.39 ± 11.28 | 38.07 ± 11.16 | 65.28 ± 9.34 | 47.38 ± 6.06 | 38.47 ± 12.18 | 44.53 ± 11.57 |
| Day 58 | -2.79 ± 8.79 | — | 29.12 ± 12.18 | — | 39.33 ± 5.29 | — | 44.24 ± 13.63 |
| Day 60 | -7.26 ± 5.69 | — | 18.64 ± 9.41 | — | 38.07 ± 7.47 | — | 36.75 ± 11.16 |
| Day 62 | -8.41 ± 5.03 | — | 24.58 ± 10.61 | — | 38.52 ± 7.59 | — | 31.71 ± 10.53 |
| Day 64 | -8.42 ± 5.15 | 34.60 ± 12.41 | 19.54 ± 5.71 | 77.50 ± 10.29 | 38.38 ± 7.43 | 27.78 ± 13.26 | 45.24 ± 9.78 |
| Day 71 | -8.14 ± 4.26 | 34.29 ± 11.32 | 16.29 ± 6.39 | 52.77 ± 7.72 | 44.72 ± 9.30 | 25.46 ± 15.12 | 47.47 ± 9.99 |
| Day 72 | -7.83 ± 3.96 | 32.18 ± 12.27 | — | 50.19 ± 10.57 | — | 19.60 ± 10.46 | — |
| Day 74 | -11.97 ± 7.31 | 20.46 ± 15.03 | — | 57.85 ± 10.91 | — | 15.07 ± 13.92 | — |
| Day 76 | -9.30 ± 5.16 | 40.67 ± 12.44 | — | 51.82 ± 9.53 | — | 17.91 ± 12.86 | — |
| Day 78 | -3.54 ± 4.26 | 33.07 ± 12.20 | 19.74 ± 6.38 | 64.46 ± 11.16 | 43.30 ± 14.16 | 13.37 ± 7.30 | 47.07 ± 12.38 |
| Day 85 | -1.70 ± 3.61 | 26.01 ± 12.18 | 7.70 ± 5.59 | 69.90 ± 21.35 | 38.27 ± 4.20 | 18.68 ± 9.63 | 42.53 ± 14.53 |
| Day 99 | -3.35 ± 4.67 | 23.36 ± 10.68 | -1.91 ± 3.22 | 24.89 ± 14.52 | 5.10 ± 1.62 | 17.55 ± 17.51 | 13.75 ± 6.54 |
| Day 113 | 7.31 ± 6.57 | 10.26 ± 9.51 | -3.15 ± 3.85 | 14.75 ± 5.08 | -5.26 ± 10.20 | -6.58 ± 3.92 | 14.50 ± 5.38 |
| Day 127 | 0.52 ± 5.26 | -2.73 ± 7.12 | -2.30 ± 4.12 | 9.62 ± 6.27 | 1.13 ± 6.36 | -6.54 ± 7.54 | 5.26 ± 5.75 |
| Day 141 | 2.55 ± 5.44 | -1.68 ± 6.67 | -5.98 ± 5.03 | 2.90 ± 7.10 | 3.75 ± 3.96 | -4.71 ± 4.43 | 9.34 ± 3.25 |
| Day 155 | 5.25 ± 5.28 | -0.82 ± 6.82 | -4.10 ± 4.67 | 6.15 ± 4.92 | 5.12 ± 6.77 | -4.11 ± 3.38 | 6.78 ± 8.32 |
| Day 169 | 3.90 ± 5.22 | -1.37 ± 6.27 | -5.72 ± 5.75 | 2.33 ± 4.19 | 16.26 ± 7.56 | -4.76 ± 5.36 | -0.42 ± 6.39 |
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 2 | -7.31 ± 4.30 | 12.29 ± 9.15 | -11.32 ± 4.22 | 8.05 ± 9.96 | -7.07 ± 7.36 | -10.15 ± 10.74 | -6.57 ± 3.50 |
| Day 4 | -5.51 ± 5.87 | 1.10 ± 12.49 | -19.03 ± 9.12 | -26.84 ± 4.63 | -25.85 ± 7.05 | -22.01 ± 3.66 | -34.13 ± 3.28 |
| Day 6 | -12.60 ± 5.74 | -8.29 ± 12.56 | -26.11 ± 10.32 | -28.04 ± 7.70 | -36.98 ± 5.38 | -28.83 ± 6.44 | -35.78 ± 3.37 |
| Day 8 | -17.79 ± 5.06 | -14.65 ± 11.02 | -31.59 ± 10.22 | -28.92 ± 3.05 | -35.93 ± 3.90 | -42.09 ± 4.09 | -43.93 ± 3.44 |
| Day 15 | -18.86 ± 5.92 | -14.39 ± 9.41 | -35.11 ± 8.69 | -35.27 ± 4.30 | -33.00 ± 7.65 | -39.34 ± 2.85 | -48.74 ± 5.56 |
| Day 22 | -12.98 ± 6.18 | -4.88 ± 9.99 | -29.97 ± 12.42 | -37.34 ± 3.50 | -22.85 ± 7.88 | -36.63 ± 6.67 | -39.21 ± 4.70 |
| Day 29 | -10.94 ± 6.87 | 0.31 ± 6.08 | -21.11 ± 8.86 | -25.43 ± 6.08 | -21.54 ± 10.95 | -32.76 ± 4.85 | -34.53 ± 8.14 |
| Day 36 | -20.96 ± 7.87 | 4.50 ± 11.96 | -21.42 ± 12.02 | -38.33 ± 2.21 | -29.20 ± 15.71 | -36.51 ± 9.31 | -50.32 ± 4.78 |
| Day 43 | -14.14 ± 7.40 | 3.91 ± 9.40 | -13.79 ± 15.06 | -34.04 ± 3.35 | -20.49 ± 12.73 | -28.54 ± 6.07 | -44.64 ± 7.31 |
| Day 50 | -12.62 ± 7.98 | -4.78 ± 11.11 | — | -26.11 ± 5.90 | — | -22.42 ± 15.96 | — |
| Day 57 | -17.59 ± 6.11 | 14.35 ± 10.32 | -4.53 ± 17.99 | -23.74 ± 6.45 | -13.47 ± 15.73 | -25.25 ± 12.27 | -31.52 ± 7.89 |
| Day 58 | -20.27 ± 7.58 | — | -9.15 ± 9.82 | — | -9.63 ± 15.05 | — | -28.19 ± 8.64 |
| Day 60 | -14.95 ± 10.06 | — | -8.80 ± 13.64 | — | -22.34 ± 16.06 | — | -28.04 ± 11.68 |
| Day 62 | -14.01 ± 10.87 | — | -25.09 ± 10.87 | — | -21.83 ± 18.62 | — | -41.37 ± 8.69 |
| Day 64 | -10.22 ± 7.59 | 6.59 ± 16.03 | -20.16 ± 8.81 | -20.09 ± 4.55 | -18.72 ± 14.04 | -20.03 ± 12.81 | -34.86 ± 10.25 |
| Day 71 | -15.23 ± 5.58 | 26.63 ± 14.92 | -14.42 ± 11.82 | -18.24 ± 7.26 | -14.03 ± 13.60 | -11.02 ± 18.12 | -38.38 ± 4.37 |
| Day 72 | -19.21 ± 6.72 | 11.70 ± 13.66 | — | -17.32 ± 7.84 | — | -8.98 ± 16.64 | — |
| Day 74 | -6.15 ± 8.32 | 7.40 ± 11.86 | — | -16.32 ± 6.94 | — | -9.80 ± 14.64 | — |
| Day 76 | -19.35 ± 5.70 | 11.70 ± 9.88 | — | -17.14 ± 9.24 | — | -17.12 ± 13.70 | — |
| Day 78 | -18.50 ± 6.03 | 9.18 ± 11.45 | -14.82 ± 10.85 | -17.99 ± 10.44 | 11.88 ± 21.63 | -5.24 ± 18.22 | -21.66 ± 11.50 |
| Day 85 | -12.69 ± 5.84 | 14.95 ± 13.45 | 8.97 ± 10.90 | -13.06 ± 9.08 | 13.77 ± 22.18 | -16.89 ± 16.84 | -17.17 ± 10.09 |
| Day 99 | -20.31 ± 5.21 | 7.45 ± 8.41 | -15.79 ± 9.03 | -7.79 ± 8.64 | -5.14 ± 17.67 | -13.22 ± 17.06 | -8.18 ± 10.80 |
| Day 113 | -15.61 ± 6.74 | 4.66 ± 11.35 | -18.77 ± 12.28 | 0.18 ± 13.58 | -7.88 ± 13.06 | -10.06 ± 10.22 | -8.20 ± 12.19 |
| Day 127 | -19.03 ± 5.79 | -5.63 ± 13.21 | -12.96 ± 12.78 | 0.46 ± 10.01 | -4.92 ± 18.73 | 1.68 ± 14.91 | -16.92 ± 13.00 |
| Day 141 | -21.10 ± 6.53 | 4.86 ± 10.74 | -12.11 ± 14.71 | 1.99 ± 9.89 | 13.34 ± 14.80 | -22.48 ± 5.32 | -21.35 ± 9.69 |
| Day 155 | -21.03 ± 5.72 | -0.02 ± 8.21 | -3.37 ± 12.01 | 7.94 ± 6.33 | 1.27 ± 14.71 | -14.43 ± 12.92 | -15.00 ± 14.96 |
| Day 169 | -16.59 ± 6.74 | -1.13 ± 8.37 | -9.38 ± 12.56 | -0.92 ± 15.29 | -0.27 ± 10.41 | -15.61 ± 11.74 | -10.10 ± 9.54 |
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 2 | -5.72 ± 4.12 | -13.34 ± 6.82 | -2.09 ± 12.69 | 7.94 ± 4.48 | -1.06 ± 5.09 | 8.68 ± 5.69 | -5.04 ± 8.62 |
| Day 4 | -18.14 ± 2.42 | 0.35 ± 13.61 | 18.59 ± 17.92 | 2.94 ± 19.63 | 1.34 ± 10.38 | -5.59 ± 31.57 | -3.14 ± 14.09 |
| Day 6 | -22.64 ± 5.59 | -2.67 ± 8.79 | 23.15 ± 15.52 | 8.42 ± 17.70 | 43.89 ± 18.45 | 20.35 ± 21.69 | -4.22 ± 11.74 |
| Day 8 | -22.84 ± 5.19 | -0.20 ± 6.59 | 16.68 ± 13.79 | -7.82 ± 8.93 | 12.58 ± 13.18 | -2.24 ± 9.43 | 9.33 ± 24.92 |
| Day 15 | -8.84 ± 5.93 | 7.31 ± 12.26 | 18.72 ± 12.98 | -10.00 ± 7.92 | 67.27 ± 35.74 | -1.40 ± 14.42 | 12.46 ± 27.05 |
| Day 22 | -9.12 ± 4.45 | 63.58 ± 41.80 | 28.93 ± 15.69 | 0.65 ± 17.49 | 69.17 ± 22.48 | 24.27 ± 21.16 | 48.13 ± 37.16 |
| Day 29 | -7.45 ± 6.70 | 26.13 ± 14.71 | 41.90 ± 10.87 | 34.10 ± 25.51 | 41.45 ± 17.60 | 23.91 ± 21.12 | 3.68 ± 19.02 |
| Day 36 | -14.24 ± 4.63 | 25.21 ± 11.90 | 57.32 ± 15.99 | 22.33 ± 25.29 | 54.47 ± 18.24 | 37.99 ± 26.79 | 10.94 ± 14.70 |
| Day 43 | -14.84 ± 5.36 | 28.17 ± 11.49 | 47.38 ± 19.72 | 23.77 ± 26.38 | 73.55 ± 22.75 | 39.90 ± 17.90 | 37.55 ± 31.09 |
| Day 50 | -7.02 ± 9.81 | 30.25 ± 19.47 | — | 34.06 ± 31.75 | — | 41.77 ± 27.38 | — |
| Day 57 | -13.17 ± 6.57 | 66.13 ± 35.48 | 31.59 ± 25.03 | 26.12 ± 20.92 | 26.23 ± 13.73 | 26.14 ± 26.62 | 23.55 ± 28.82 |
| Day 58 | -10.21 ± 7.73 | — | 34.80 ± 16.82 | — | 57.65 ± 25.32 | — | 24.71 ± 15.33 |
| Day 60 | -8.41 ± 9.17 | — | 52.00 ± 20.18 | — | 72.18 ± 16.59 | — | 56.06 ± 31.40 |
| Day 62 | -2.33 ± 10.30 | — | 48.83 ± 20.01 | — | 47.94 ± 18.36 | — | 37.93 ± 22.34 |
| Day 64 | -6.40 ± 8.29 | 19.81 ± 11.29 | 62.54 ± 17.33 | 30.11 ± 13.35 | 62.07 ± 18.54 | 49.59 ± 26.25 | 64.46 ± 31.92 |
| Day 71 | -10.38 ± 3.86 | 21.65 ± 17.69 | 40.97 ± 15.06 | 7.80 ± 17.50 | 68.44 ± 26.27 | 11.07 ± 24.13 | 15.84 ± 12.81 |
| Day 72 | -19.26 ± 8.34 | 32.07 ± 19.22 | — | 41.99 ± 35.57 | — | 30.65 ± 17.43 | — |
| Day 74 | -9.74 ± 6.73 | 32.25 ± 25.26 | — | 21.37 ± 17.25 | — | 71.86 ± 39.62 | — |
| Day 76 | -8.27 ± 6.56 | 32.24 ± 14.18 | — | 2.58 ± 14.33 | — | 20.58 ± 20.98 | — |
| Day 78 | -16.60 ± 5.70 | 21.00 ± 14.55 | 44.03 ± 11.32 | 31.00 ± 22.68 | 56.98 ± 25.29 | 28.62 ± 13.12 | 22.73 ± 27.28 |
| Day 85 | -3.49 ± 5.98 | 16.48 ± 11.90 | 47.95 ± 9.94 | -3.99 ± 13.52 | 24.90 ± 19.86 | 33.55 ± 22.61 | 29.25 ± 25.49 |
| Day 99 | -20.78 ± 5.77 | 20.49 ± 13.44 | 14.08 ± 7.81 | 5.91 ± 26.94 | 12.34 ± 11.46 | 3.12 ± 12.69 | 2.69 ± 19.10 |
| Day 113 | -7.05 ± 7.87 | 0.16 ± 12.53 | 13.91 ± 11.95 | -5.87 ± 11.21 | -10.83 ± 19.52 | 13.19 ± 18.27 | 16.73 ± 18.23 |
| Day 127 | -12.50 ± 5.08 | -16.74 ± 7.08 | 3.14 ± 14.76 | -11.32 ± 7.81 | -7.07 ± 6.79 | -2.02 ± 17.24 | 6.96 ± 13.62 |
| Day 141 | -16.41 ± 3.26 | -5.85 ± 9.79 | -8.33 ± 8.30 | -19.91 ± 6.71 | -4.19 ± 6.92 | -16.85 ± 13.53 | 10.80 ± 18.12 |
| Day 155 | -15.06 ± 4.78 | 1.27 ± 8.24 | 10.09 ± 11.69 | -15.78 ± 7.72 | 17.62 ± 9.94 | -3.50 ± 10.45 | 8.76 ± 16.71 |
| Day 169 | -9.95 ± 7.25 | -18.84 ± 7.75 | -10.08 ± 13.08 | -19.71 ± 9.00 | 30.72 ± 20.07 | -3.01 ± 10.49 | 15.09 ± 21.69 |
| percent change | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Day 15 | -5.6 ± 4.7 | 3135.6 ± 665.6 | 5630.4 ± 478.9 | 6087.5 ± 651.1 | 7532.4 ± 627.8 | 2809.3 ± 241.8 | 6816.0 ± 775.1 |
| Day 29 | -3.6 ± 5.4 | 4068.2 ± 923.8 | 2335.8 ± 283.2 | 7713.1 ± 997.9 | 4993.3 ± 890.2 | 3904.4 ± 399.2 | 4573.0 ± 614.4 |
| Day 43 | 4.4 ± 8.5 | 4669.2 ± 1119.6 | 6229.6 ± 475.2 | 9023.8 ± 1003.7 | 8471.0 ± 506.6 | 4613.9 ± 486.2 | 6486.0 ± 621.2 |
| Day 57 | 0.4 ± 7.2 | 5143.9 ± 1145.2 | 3024.9 ± 290.7 | 8450.2 ± 545.0 | 6137.5 ± 1319.7 | 4450.8 ± 471.5 | 4739.5 ± 660.2 |
| Day 71 | -1.9 ± 5.7 | 4949.6 ± 1133.1 | 6905.1 ± 875.7 | 10130.3 ± 1041.3 | 9114.5 ± 812.4 | 5405.1 ± 667.6 | 7735.8 ± 949.8 |
| Day 85 | -2.2 ± 5.8 | 4886.5 ± 1085.4 | 3004.2 ± 538.5 | 10566.4 ± 1667.4 | 5403.5 ± 1285.7 | 5254.5 ± 588.9 | 4873.7 ± 520.7 |
| Day 99 | -3.5 ± 6.9 | 2496.0 ± 806.8 | 952.8 ± 362.7 | 6748.3 ± 1165.3 | 2124.2 ± 736.4 | 1960.4 ± 461.1 | 2183.7 ± 520.7 |
| Day 113 | -7.3 ± 6.5 | 883.2 ± 397.5 | 399.4 ± 175.9 | 3556.2 ± 627.9 | 473.3 ± 129.2 | 395.4 ± 57.0 | 804.9 ± 257.7 |
| Day 127 | 0.2 ± 5.8 | 364.9 ± 185.9 | 161.5 ± 67.9 | 1410.2 ± 273.0 | 202.6 ± 58.2 | 242.5 ± 150.0 | 311.3 ± 117.9 |
| Day 141 | 2.1 ± 7.5 | 203.9 ± 110.6 | 84.6 ± 47.3 | 524.3 ± 109.9 | 178.2 ± 101.5 | 74.2 ± 25.5 | 128.2 ± 61.5 |
| Day 155 | 2.6 ± 9.0 | 118.8 ± 78.9 | 57.4 ± 35.5 | 298.6 ± 67.4 | 41.0 ± 21.8 | 88.6 ± 43.3 | 48.3 ± 36.6 |
| Day 169 | 1.9 ± 9.1 | 76.1 ± 37.7 | 40.3 ± 27.8 | 177.3 ± 37.8 | 845.3 ± 528.9 | 713.7 ± 688.9 | 16.8 ± 20.9 |
| mg/dL | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Ionized Calcium | 0.05 ± 0.17 | 0.12 ± 0.10 | 0.06 ± 0.21 | -0.07 ± 0.18 | -0.05 ± 0.04 | -0.14 ± 0.18 | -0.06 ± 0.14 |
Collected over 169 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/12 (0%) | 10/12 (83.3%) |
| Romosozumab 1 mg/kg Q2W in Women | — | 0/6 (0%) | 6/6 (100%) |
| Romosozumab 2 mg/kg Q4W in Women | — | 0/6 (0%) | 6/6 (100%) |
| Romosozumab 2 mg/kg Q2W in Women | — | 0/6 (0%) | 6/6 (100%) |
| Romosozumab 3 mg/kg Q4W in Women | — | 1/6 (16.7%) | 5/6 (83.3%) |
| Romosozumab 1 mg/kg Q2W in Men | — | 0/6 (0%) | 5/6 (83.3%) |
| Romosozumab 3 mg/kg Q4W in Men | — | 1/6 (16.7%) | 5/6 (83.3%) |
| Event | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| HAEMORRHAGIC ANAEMIABlood and lymphatic system disorders | 0/12 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| CORONARY ARTERY DISEASECardiac disorders | 0/12 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 1/6 |
| HAEMATOCHEZIAGastrointestinal disorders | 0/12 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| Event | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men |
|---|---|---|---|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 1/12 | 3/6 | 2/6 | 1/6 | 0/6 | 2/6 | 0/6 |
| BACK PAINMusculoskeletal and connective tissue disorders | 2/12 | 3/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| HEADACHENervous system disorders | 4/12 | 1/6 | 1/6 | 1/6 | 2/6 | 3/6 | 2/6 |
| INFLUENZA LIKE ILLNESSGeneral disorders | 0/12 | 2/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| INJECTION SITE PAINGeneral disorders | 0/12 | 0/6 | 0/6 | 2/6 | 0/6 | 1/6 | 0/6 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 2/12 | 0/6 | 0/6 | 2/6 | 1/6 | 1/6 | 1/6 |
| PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders | 2/12 | 0/6 | 0/6 | 2/6 | 1/6 | 0/6 | 1/6 |
| DYSURIARenal and urinary disorders | 0/12 | 2/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| VISION BLURREDEye disorders | 3/12 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| ANAEMIABlood and lymphatic system disorders | 1/12 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
All treated participants
| Age, Continuous(years) | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 59.1 ± 5.6 | 56.8 ± 7.8 | 57.3 ± 6.6 | 62.5 ± 8.0 | 54.3 ± 7.8 | 61.2 ± 9.0 | 59.3 ± 12.7 | 58.7 ± 8.0 |
| Age, Customized(Participants) | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men | Total |
|---|---|---|---|---|---|---|---|---|
| 18 to 64 years | 11 | 4 | 5 | 4 | 5 | 3 | 4 | 36 |
| 65 to 74 years | 1 | 2 | 1 | 1 | 1 | 3 | 1 | 10 |
| ≥ 75 years | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 2 |
| Sex: Female, Male(Participants) | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 8 | 6 | 6 | 6 | 6 | 0 | 0 | 32 |
| Male | 4 | 0 | 0 | 0 | 0 | 6 | 6 | 16 |
| Race/Ethnicity, Customized(Participants) | Placebo | Romosozumab 1 mg/kg Q2W in Women | Romosozumab 2 mg/kg Q4W in Women | Romosozumab 2 mg/kg Q2W in Women | Romosozumab 3 mg/kg Q4W in Women | Romosozumab 1 mg/kg Q2W in Men | Romosozumab 3 mg/kg Q4W in Men | Total |
|---|---|---|---|---|---|---|---|---|
| White | 8 | 4 | 5 | 3 | 3 | 3 | 3 | 29 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Hispanic or Latino | 3 | 2 | 1 | 3 | 3 | 3 | 2 | 17 |
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
No study locations are listed for this record.
Ran from Nov 2007 to primary completion in Dec 2008, 12 months.
Results were first posted in Jul 2019, 10 years 7 months after primary completion.
Of 11 phase 1 interventional studies under Bone Diseases, Metabolic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Romosozumab