Phase 3
N=7,808
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00089791 ↗Enrolled (actual)
7,808
Serious AEs
25.5%
Results posted
Jan 2014
Primary outcome: Primary: Number of Participants With New Vertebral Fractures — 264; 86 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo (Drug); Denosumab (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With New Vertebral Fractures |
264; 86 | <0.0001 sig |
| SECONDARY Number of Participants With Nonvertebral Fractures |
293; 238 | 0.0106 sig |
| SECONDARY Number of Participants With a Hip Fracture |
43; 26 | 0.0362 sig |
Summary
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
Eligibility Criteria
Inclusion Criteria
- Women who are 60 to 90 years of age may be eligible to participate
- Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5
Exclusion Criteria
- BMD T-Score at the hip or the spine of less than -4.0
- Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry
Data sourced from ClinicalTrials.gov (NCT00089791). 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.