Study of Transitioning From Alendronate to Denosumab
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/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
- 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
Outcome Measures for this Clinical Trial
Primary Measures
- Percent Change From Baseline in Total Hip Bone Mineral Density
- Time Frame: Baseline, 12 months
Safety Issue?: No
- Time Frame: Baseline, 12 months
Secondary Measures
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density
- Time Frame: Baseline, 12 months
Safety Issue?: No
- Time Frame: Baseline, 12 months
- Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
- Time Frame: Baseline, 3 months
Safety Issue?: No
- Time Frame: Baseline, 3 months
Criteria for Participation in this Clinical Trial
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 Bone Mineral Density (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 Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
- Administration of any bisphosphonate other than alendronate (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
Clinical Trial Investigator Information
Lead Investigator: Amgen Industry
Overall Clinical Trial Officials and Contacts
MD Study Director Amgen
Related Publications
Citations Reporting Results
Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;25(1):72-81.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00377819
