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Study of Transitioning From Alendronate to Denosumab

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00377819
First received: September 14, 2006
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: alendronate
Drug: Denosumab (AMG 162)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent Change From Baseline in Total Hip Bone Mineral Density [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.


Secondary Outcome Measures:
  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.

  • Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I) [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.


Enrollment: 504
Study Start Date: September 2006
Study Completion Date: July 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: denosumab Drug: Denosumab (AMG 162)
60 mg SC q 6 mos
Active Comparator: alendronate Drug: alendronate
70 mg oral QW

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal females 55 yrs or older
  • Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
  • Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4

Exclusion Criteria:

  • Vitamin D deficiency
  • Administration of intravenous bisphosphonate, or
  • fluoride (except for dental treatment) or
  • strontium ranelate
  • Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
  • Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening
  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: NCT00377819

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00377819     History of Changes
Other Study ID Numbers: 20050234
Study First Received: September 14, 2006
Results First Received: July 1, 2010
Last Updated: June 30, 2011
Health Authority: Canada: Health Canada
Estonia: State Agency of Medicines
France: Ministry of Health
Italy: Ministry of Health
Poland: Drug Institut
Portugal: National Institute of Pharmacy and Medicines
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
RANKL
RANK
denosumab
AMG 162
osteoporosis
bone turnover
bone mineral density
clinical trial
postmenopausal osteoporosis
alendronate
total hip bone mineral density

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014