Phase 3
Completed N=7,180
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT01575834 ↗Enrolled (actual)
7,180
Serious AEs
14.8%
Results posted
Nov 2018
Primary outcomePrimary: Percentage of Participants With New Vertebral Fracture Through Month 12 — 1.8; 0.5 percentage of participants — p=< 0.001
◆ Published Evidence
Highly cited
167citations · ~24 / year
Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment.
Summary
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
Linked Publications (5)
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Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment.
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Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension.
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Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial.
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Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study.
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Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With New Vertebral Fracture Through Month 12 |
1.8; 0.5 | < 0.001 sig |
| PRIMARY Percentage of Participants With New Vertebral Fracture Through Month 24 |
2.5; 0.6 | < 0.001 sig |
| SECONDARY Percentage of Participants With a Clinical Fracture Through Month 12 |
2.5; 1.6 | 0.008 sig |
| SECONDARY Percentage of Participants With a Nonvertebral Fracture Through Month 12 |
2.1; 1.6 | 0.096 |
| SECONDARY Percentage of Participants With a Nonvertebral Fracture Through Month 24 |
3.6; 2.7 | 0.057 |
| SECONDARY Percentage of Participants With a Clinical Fracture Through Month 24 |
4.1; 2.8 | 0.096 |
| SECONDARY Percentage of Participants With a Major Nonvertebral Fracture Through Month 12 |
1.5; 1.0 | 0.096 |
| SECONDARY Percentage of Participants With a Major Nonvertebral Fracture Through Month 24 |
2.8; 1.9 | 0.096 |
| SECONDARY Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12 |
1.8; 0.5 | 0.096 |
| SECONDARY Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24 |
2.5; 0.7 | 0.096 |
| SECONDARY Percentage of Participants With a Hip Fracture Through Month 12 |
0.4; 0.2 | 0.18 |
| SECONDARY Percentage of Participants With a Hip Fracture Through Month 24 |
0.6; 0.3 | 0.12 |
| SECONDARY Percentage of Participants With a Major Osteoporotic Fracture Through Month 12 |
1.8; 1.1 | 0.012 sig |
| SECONDARY Percentage of Participants With a Major Osteoporotic Fracture Through Month 24 |
3.1; 1.9 | 0.002 sig |
| SECONDARY Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12 |
0.3; 0.03 | 0.011 sig |
| SECONDARY Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24 |
0.5; 0.03 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12 |
0.4; 13.1 | < 0.001 sig |
| SECONDARY Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24 |
5.5; 16.6 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12 |
0.3; 6.0 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24 |
3.2; 8.5 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12 |
0.3; 5.5 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24 |
2.3; 7.3 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)
Exclusion Criteria
- BMD T-score of ≤ -3.50 at the total hip or femoral neck
- History of hip fracture
- Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
- Use of agents affecting bone metabolism
- History of metabolic or bone disease (except osteoporosis)
- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
Data sourced from ClinicalTrials.gov (NCT01575834) 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.