Phase 3
N=4,093
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Postmenopausal Women With Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01631214 ↗Enrolled (actual)
4,093
Serious AEs
22.1%
Results posted
Dec 2018
Primary outcome: Primary: Percentage of Participants With New Vertebral Fractures Through Month 24 — 8.0; 4.1 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Romosozumab (Biological); Alendronate (Drug); Placebo to Romosozumab (Drug); Placebo to Alendronate (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Feb 2017
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 |
Summary
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
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). 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.