Official Title: “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”

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Denosumab
  • denosumab 60 mg SC q 6 mos
• Drug: Alendronate
  • Alendronate 70 mg PO QW

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • denosumab and placebo for alendronate
• Active Comparator: 2
  • Placebo for denosumab and alendronate

Primary Measures

• Percent change in the distal radius measurements as determined by Xtreme CT from baseline to 12 months.
  • Time Frame: One year
    Safety Issue?: No

Secondary Measures

• Percent change at 6 and 12 months in various measures of bone parameters.
  • Time Frame: One year
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Amgen

Overall Clinical Trial Officials and Contacts

MD Study Director Amgen  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00293813

Study ID Number: 20050179

ClinicalTrials.gov Identifier: NCT00293813

Health Authority: Argentina: Ministry of Health

AmgenTrials clinical trials website