Phase 3
N=7,180
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01575834 ↗Enrolled (actual)
7,180
Serious AEs
14.8%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Participants With New Vertebral Fracture Through Month 12 — 1.8; 0.5 percentage of participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Romosozumab (Drug); Placebo (Drug); Denosumab (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Dec 2015
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 |
Summary
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
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). 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.