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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Actonel® Drug: Denosumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2009
Actual Primary Completion Date : December 21, 2011
Actual Study Completion Date : March 5, 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Denosumab 60 mg Drug: Denosumab
Denosumab 60 mg, once every 6 months, Subcutaneous
Active Comparator: Risedronate 150 mg QM 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919711


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00919711    
Other Study ID Numbers: 20080099
First Posted: June 12, 2009    Key Record Dates
Results First Posted: December 12, 2012
Last Update Posted: July 28, 2020
Last Verified: March 2020
Keywords provided by Amgen:
Menopausal Osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Risedronic Acid
 Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents