Study of Transitioning From Alendronate to Denosumab
June 30, 2011 updated by: Amgen
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
504
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
51 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: denosumab
|
60 mg SC q 6 mos
|
|
Active Comparator: alendronate
|
70 mg oral QW
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Change From Baseline in Total Hip Bone Mineral Density
Time Frame: Baseline, 12 months
|
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
|
Baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density
Time Frame: Baseline, 12 months
|
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
|
Baseline, 12 months
|
|
Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
Time Frame: Baseline, 3 months
|
Percent Change From Baseline to Month 3 in Serum CTX-I.
Percent change calculated using [(3 month value - baseline value) / baseline value]*100.
|
Baseline, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149.
- Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.
- 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. doi: 10.1359/jbmr.090716.
- Gold DT, Horne R, Coon CD, Price MA, Borenstein J, Varon SF, Satram-Hoang S, Macarios D. Development, reliability, and validity of a new Preference and Satisfaction Questionnaire. Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 14, 2006
First Submitted That Met QC Criteria
September 14, 2006
First Posted (Estimate)
September 18, 2006
Study Record Updates
Last Update Posted (Estimate)
July 11, 2011
Last Update Submitted That Met QC Criteria
June 30, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20050234
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.