Phase 3
Completed N=4,093
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT01631214 ↗
Enrolled (actual)
4,093
Serious AEs
22.1%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With New Vertebral Fractures Through Month 24 — 8.0; 4.1 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
1,472citations · ~164 / year
Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.
Summary
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
Linked Publications (5)
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Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.
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Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial.
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T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial.
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Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials.
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Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With New Vertebral Fractures Through Month 24 |
8.0; 4.1 | <0.001 sig |
| PRIMARY Percentage of Participants With a Clinical Fracture at the Primary Analysis |
13.0; 9.7 | <0.001 sig |
| SECONDARY Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis |
10.6; 8.7 | 0.040 sig |
| SECONDARY Percentage of Participants With Any Fracture at the Primary Analysis |
19.1; 13.0 | <0.001 sig |
| SECONDARY Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24 |
9.2; 4.8 | <0.001 sig |
| SECONDARY Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis |
9.6; 7.1 | 0.004 sig |
| SECONDARY Percentage of Participants With a Hip Fracture at the Primary Analysis |
3.2; 2.0 | 0.015 sig |
| SECONDARY Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24 |
2.5; 1.3 | 0.008 sig |
| SECONDARY Percentage of Participants With a Clinical Fracture Through Month 24 |
9.6; 7.1 | 0.005 sig |
| SECONDARY Percentage of Participants With a Nonvertebral Fracture Through Month 24 |
7.8; 6.3 | 0.074 |
| SECONDARY Percentage of Participants With a Hip Fracture Through Month 24 |
2.1; 1.5 | 0.17 |
| SECONDARY Percentage of Participants With a Clinical Vertebral Fracture Through Month 24 |
2.1; 0.9 | <0.001 sig |
| SECONDARY Percentage of Participants With a Clinical Fracture Through Month 12 |
5.4; 3.9 | 0.027 sig |
| SECONDARY Percentage of Participants With New Vertebral Fractures Through Month 12 |
5.0; 3.2 | 0.008 sig |
| SECONDARY Percentage of Participants With Any Fracture Through Month 12 |
9.2; 6.5 | 0.002 sig |
| SECONDARY Percentage of Participants With a Nonvertebral Fracture Through Month 12 |
4.6; 3.4 | 0.057 |
| SECONDARY Percentage of Participants With a Hip Fracture Through Month 12 |
1.1; 0.7 | 0.19 |
| SECONDARY Percentage of Participants With a Major Osteoporotic Fracture Through Month 12 |
4.2; 3.0 | 0.053 |
| SECONDARY Percentage of Participants With a Clinical Vertebral Fracture Through Month 12 |
0.9; 0.5 | 0.14 |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24 |
7.2; 15.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24 |
3.5; 7.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24 |
2.3; 6.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12 |
5.0; 13.7 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12 |
2.8; 6.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12 |
1.7; 4.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36 |
7.8; 15.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36 |
3.5; 7.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36 |
2.4; 6.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:
- BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
- at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR
- at least 2 mild (SQ1) vertebral fractures OR
- BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
- at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
- a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.
Exclusion Criteria
- History of metabolic or bone disease (except osteoporosis)
- Use of agents affecting bone metabolism
- Vitamin D insufficiency
- History of solid organ or bone marrow transplants
- Hyper- or hypocalcemia
- Hyper- or hypothyroidism
- Hyper- or hypoparathyroidism
- Possible signs of intolerance to alendronate
Data sourced from ClinicalTrials.gov (NCT01631214) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.