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Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy

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ClinicalTrials.gov Identifier: NCT00919711
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : December 12, 2012
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE June 11, 2009
First Posted Date  ICMJE June 12, 2009
Results First Submitted Date  ICMJE November 15, 2012
Results First Posted Date  ICMJE December 12, 2012
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE September 1, 2009
Actual Primary Completion Date December 21, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
Percentage change from baseline in total hip bone mass density (BMD). [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2012)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
  • Percent change from baseline in serum type 1 C-terminal telopeptide (CTX). [ Time Frame: 1 month ]
  • Percent change from baseline in femoral neck BMD. [ Time Frame: 12 months ]
  • Percent change from baseline in lumbar spine BMD. [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Actonel®
    Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).
    Other Name: Risedronate
  • Drug: Denosumab
    Denosumab 60 mg, once every 6 months, Subcutaneous
Study Arms  ICMJE
  • Experimental: Denosumab 60 mg
    Intervention: Drug: Denosumab
  • Active Comparator: Risedronate 150 mg QM
    Intervention: Drug: Actonel®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2011)
870
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
800
Actual Study Completion Date  ICMJE March 5, 2012
Actual Primary Completion Date December 21, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Austria,   Canada,   Denmark,   France,   Germany,   Greece,   Ireland,   Italy,   Netherlands,   Portugal,   Spain,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00919711
Other Study ID Numbers  ICMJE 20080099
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP