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

Verified by: Amgen, March 2011
First Received: February 17, 2006 | Last Updated: March 31, 2011 | Phase: Phase 2 | Start Date: May 2006
Overall Status: Completed | Estimated Enrollment: 247
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This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: Alendronate
    • Alendronate 70 mg PO QW
  • Drug: Denosumab
    • denosumab 60 mg SC q 6 mos
  • Drug: Placebo
    • Placebo for alendronate and placebo for denosumab

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: 3
    • Placebo for denosumab and placebo for alendronate
  • Experimental: 1
    • denosumab and placebo for alendronate
  • Active Comparator: 2
    • Placebo for denosumab and alendronate

Outcome Measures for this Clinical Trial

Primary Measures

  • Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
    • Time Frame: 12 months
      Safety Issue?: No

Secondary Measures

  • Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
    • Time Frame: 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Amgen Industry

Overall Clinical Trial Officials and Contacts

MD Study Director Amgen  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

Study ID Number: 20050179

ClinicalTrials.gov Identifier: NCT00293813

Health Authority: France: Afssaps - French Health Products Safety Agency

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

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