- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00919711
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
July 14, 2020 updated by: Amgen
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned From Weekly or Daily Alendronate Therapy
A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
870
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
53 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Ambulatory, post menopausal women aged 55 years or older at screening. Have received their first prescription of daily or weekly alendronate therapy, for the treatment for post menopausal osteoporosis at least 1 month prior to screening. Use of raloxifene, calcitonin or hormone replacement therapy (HRT) prior to alendronate treatment will be allowed. Prior and/or current use of vitamin D and calcium will be allowed.
- Has stopped oral alendronate therapy (is denoted as non-persistent) before the screening visit or, is still taking oral alendronate therapy but does not take on a regular basis (this will be assessed by the completion of a compliance questionnaire at screening).
- Provide signed informed consent before any study-specific procedures are conducted.
Exclusion Criteria:
- Any prior or current use of medications prescribed for osteoporosis treatment other than oral daily alendronate, calcium and vitamin D. Prior use of raloxifen, calcitonin or HRT before alendronate therapy was started will be allowed.
- Hypersensitivity to Actonel® or any ingredient of Actonel® tablets.
- Contraindicated or poorly tolerant of alendronate therapy.
- Active gastric or duodenal ulcer.
- Known sensitivity to mammalian cell derived products.
- Known intolerance to calcium supplements.
- Malignancy within the last 5 years (except for cervical or basal cell carcinoma).
- Vitamin D deficiency (serum 25-OH vitamin D less than 20ng/mL (equivalent to 49.9 nanomoles per Liter) at screening.
- Current hypo- or hypercalcemia based on the central laboratory reference ranges.
- Uncontrolled hyper- or hypothyroidism (stable on antithyroid therapy or post-ablation is allowed, if the laboratory results from screening show that thyroid stimulating hormone (TSH) is within the normal range).
- Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Paget's disease of bone that may interfere with the interpretation of the findings.
- Height, weight or girth which may preclude accurate dual x-ray absorptiometry (DXA measurements).
- Fewer than 2 lumbar vertebrae (L1-L4) able to be evaluated by DXA.
- Known to have tested positive for human immunodeficiency virus.
- Previous participation in clinical trials with denosumab within the last 12 months (regardless of treatment).
- Any laboratory abnormality, physical or psychiatric disorder (including substance abuse in last 12 months) which, in the opinion of the investigator, will prevent the subject from giving written informed consent or completing the study or interfere with the interpretation of the study results.
- Currently enrolled in or within 30 days of ending another investigational device or drug trial(s).
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Denosumab 60 mg
|
Denosumab 60 mg, once every 6 months, Subcutaneous
|
Active Comparator: Risedronate 150 mg QM
|
Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Hip BMD Percent Change From Baseline at Month 12
Time Frame: Baseline to month 12
|
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry
|
Baseline to month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum CTX Percent Change From Baseline at Month 1
Time Frame: Baseline to month 1
|
Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1
|
Baseline to month 1
|
Femoral Neck BMD Percent Change From Baseline at Month 12
Time Frame: Baseline to month 12
|
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry
|
Baseline to month 12
|
Lumbar Spine BMD Percent Change From Baseline at Month 12
Time Frame: Baseline to month 12
|
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry
|
Baseline to month 12
|
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
- Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, Hawkins F, Micaelo M, Minisola S, Papaioannou N, Stone M, Ferreira I, Siddhanti S, Wagman RB, Brown JP. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone. 2014 Jan;58:48-54. doi: 10.1016/j.bone.2013.10.006. Epub 2013 Oct 17.
- 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.
Helpful Links
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 (Actual)
September 1, 2009
Primary Completion (Actual)
December 21, 2011
Study Completion (Actual)
March 5, 2012
Study Registration Dates
First Submitted
June 11, 2009
First Submitted That Met QC Criteria
June 11, 2009
First Posted (Estimate)
June 12, 2009
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 14, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Risedronic Acid
- Denosumab
Other Study ID Numbers
- 20080099
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.
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