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A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330460
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : July 19, 2010
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
Amgen

Tracking Information
First Submitted Date  ICMJE April 6, 2006
First Posted Date  ICMJE May 26, 2006
Results First Submitted Date  ICMJE June 18, 2010
Results First Posted Date  ICMJE July 19, 2010
Last Update Posted Date January 24, 2011
Study Start Date  ICMJE May 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2010)
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2010)
  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Trochanter Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
Official Title  ICMJE A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty
Brief Summary The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Osteopenia
Intervention  ICMJE
  • Drug: Alendronate
    ALN; 70 mg; oral; once weekly
  • Drug: Denosumab
    60 mg; SC; every 6 months
Study Arms  ICMJE
  • Active Comparator: Alendronate
    Subjects in this arm will receive active ALN and placebo denosumab
    Intervention: Drug: Alendronate
  • Experimental: Denosumab
    Subjects in this arm will receive active denosumab and placbo ALN
    Intervention: Drug: Denosumab
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: February 7, 2008)
1189
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: - Patient is an ambulatory postmenopausal woman - Patient has BMD value that corresponds to a T-score of less than or equal to -2.0 (g/cm2) at the lumbar spine OR total hip within range specific to the study protocol. Exclusion Criteria: o Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

  • Evidence of any of the following per subject report, chart review or central laboratory result:

    1. Hyper- or hypothyroidism; however, subjects on stable thyroid hormone replacement therapy may be allowed per the following criteria:

      • If TSH level is normal, subject is eligible for the study.
      • If TSH level is below normal range, subject is not eligible for the study.
      • If TSH level is elevated (> 5.5 mIU/mL to 10.0 mIU/mL), serum T4 should be measured. If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study.
      • If TSH level is above 10.0 mIU/mL, subject is not eligible.
    2. Current hyper- or hypoparathyroidism
    3. Elevated transaminases

      • Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase [SGOT]) ³ 2.0 x upper limits of normal (ULN)
      • Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) ³ 2.0 x ULN
    4. Significantly impaired renal function as determined by serum creatinine ³ 2.0 mg/dL
    5. Current hypo- or hypercalcemia based on the central laboratory reference ranges
    6. Active gastric or duodenal ulcer; history of significant gastrointestinal bleed requiring hospitalization or transfusion, or dyspepsia or gastroesophageal reflux disease that is uncontrolled by medication
    7. Rheumatoid Arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
    8. Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
    9. Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
    10. Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
    11. Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption
  • Received any solid organ or bone marrow transplant
  • Vitamin D deficiency (25(OH) vitamin D level < 12 ng/mL). Vitamin D repletion will be permitted and subjects may be re-screened; see Section 7.
  • Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
  • Contraindicated or poorly tolerant of ALN therapy; contraindications for ALN therapy include:

    1. Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.
    2. Inability to stand or sit upright for at least 30 minutes.
    3. Hypersensitivity to ALN or other constituents of ALN tablets o Known sensitivity to mammalian cell derived drug products
  • Known intolerance to calcium supplements
  • Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate
  • Oral bisphosphonate treatment:

    • ³ 3 months cumulatively in the past 2 years, OR
    • ³ 1 month in the past year, OR
    • Any use during the 3-month period prior to randomization
  • PTH or PTH derivatives (eg, teriparatide) within the last year
  • Administration of any of the following treatments within 3 months of randomization:

    1. Any SERM (eg, raloxifene)
    2. Tibolone
    3. Anabolic steroids or testosterone
    4. Glucocorticosteroids (³ 5 mg prednisone equivalent per day for more than 10 days)
    5. Systemic (oral, transdermal, topical) hormone replacement therapy (local vaginal estrogen preparation will be allowed)
    6. Calcitonin
    7. Calcitriol or vitamin D derivatives
    8. Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin
    9. Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists
    10. Height, weight or girth which may preclude accurate DXA measurements
  • Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA measurements
  • Both hips not evaluable by DXA (eg, history of bilateral hip replacement or pins in both hips)
  • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
  • Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
  • Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 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 Argentina,   Australia,   Belgium,   Brazil,   Canada,   Denmark,   Germany,   Spain,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00330460
Other Study ID Numbers  ICMJE 20050141
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date January 2011

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