Official Title: “A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density”

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Study Type: Interventional

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

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: alendronate
  • 70 mg oral QW
• Drug: Denosumab (AMG 162)
  • 60 mg SC q 6 mos

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: denosumab
• Active Comparator: alendronate

Primary Measures

• Change in total hip BMD over one year.
  • Time Frame: One year
    Safety Issue?: No

Secondary Measures

• Change in BMD at the spine, forearm and other hip locations. Change in bone turnover markers including CTX, BSAP P1NP and uNTX. Effect on serum calcium. Analysis of adverse events. Effect on bone histology and histomorphometry in a subset of patients.
  • Time Frame: One Year
    Safety Issue?: No

• Inclusion Criteria: Postmenopausal females 55 yrs or older; Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study; Lumbar spine or total hip
• BMD corresponding to T-score ≤ -2 and ≥ -4 -
• Exclusion Criteria: Vitamin D deficiency. Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Administration of PTH or PTH derivatives (eg; teriparatide) within the last year. Administration of any bisphosphonate other than ALN within
• 1 year of screening.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00377819

Study ID Number: 20050234

ClinicalTrials.gov Identifier: NCT00377819

Health Authority: Canada: Health Canada

AmgenTrials clinical trials website