A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00293813
First received: February 17, 2006
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Alendronate
Drug: Denosumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cortical Thickness measured by XtremeCT.


Secondary Outcome Measures:
  • Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cortical Thickness measured by XtremeCT.


Enrollment: 247
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 3
Placebo for denosumab and placebo for alendronate
Drug: Placebo
Placebo for alendronate and placebo for denosumab
Experimental: 1
denosumab and placebo for alendronate
Drug: Denosumab
denosumab 60 mg SC q 6 mos
Active Comparator: 2
Placebo for denosumab and alendronate
Drug: Alendronate
Alendronate 70 mg PO QW

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
  • Must have low bone mineral density and meet specific eligibility criteria.

Key Exclusion Criteria:

-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.

  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: NCT00293813

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

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00293813     History of Changes
Other Study ID Numbers: 20050179
Study First Received: February 17, 2006
Results First Received: December 22, 2009
Last Updated: July 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: CCPPRB Central Ethics Committee
United States: Food and Drug Administration
United States: Western Institutional Review Board
Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)
Argentina: Ministry of Health
Canada: Health Canada

Keywords provided by Amgen:
Post Menopausal
Osteoporosis
MicroCT
Amgen
denosumab
Extreme CT
XCT
Fosamax
Alendronate

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

ClinicalTrials.gov processed this record on August 28, 2014