Phase 2
N=247
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00293813 ↗Enrolled (actual)
247
Serious AEs
4.9%
Results posted
Jan 2010
Primary outcome: Primary: Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 — 2.4; 3.4; -.8 Percent Change from Baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alendronate (Drug); Denosumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 |
2.4; 3.4; -.8 | — |
| SECONDARY Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 |
4.9; 5.8; 1.4 | — |
Summary
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
Eligibility Criteria
Key Inclusion Criteria
- Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
- Must have low bone mineral density and meet specific eligibility criteria.
Key Exclusion Criteria
-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
Data sourced from ClinicalTrials.gov (NCT00293813). 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.