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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00919711
First received: June 11, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Actonel®
Drug: Denosumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Total Hip BMD Percent Change From Baseline at Month 12 [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry


Secondary Outcome Measures:
  • Serum CTX Percent Change From Baseline at Month 1 [ Time Frame: Baseline to month 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry


Enrollment: 870
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919711

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

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00919711     History of Changes
Other Study ID Numbers: 20080099
Study First Received: June 11, 2009
Results First Received: November 15, 2012
Last Updated: July 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia:Barwon Health Human research Ethics Committee
Australia:Melbourne Health Office for Research
Australia:Redcliffe Caboolture Human Research Ethics Committee
Australia:Sir Charles Gairdner Group Human Research Ethics Committee
Australia:St Vincent's Hospital Human Research Ethics Committee
Australia:Tasmanian Health and Medical Human Research Ethics Committee
Canada: Health Canada
Canada: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Central EC, called Comite de Protection des Personnes
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Greece: National Ethics Committee
Greece: National Organization for Medicines
Italy: Local Ethics Committees
Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO)
Netherlands:Medisch Ethische Commissie academisch ziekenhuis Maastricht/Universiteit Maastricht
Portugal: Central EC, CEIC - Comissao de Etica para a Investigacao Clinica
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Australia: Bellberry Human Research Ethics Committee
United Kingdom: Main Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Menopausal Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014