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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:
ClinicalTrials.gov Identifier:
NCT00293813
First Posted: February 20, 2006
Last Update Posted: July 25, 2014
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.
Information provided by (Responsible Party):
Amgen
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

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): NCT00293813


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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00293813     History of Changes
Other Study ID Numbers: 20050179
First Submitted: February 17, 2006
First Posted: February 20, 2006
Results First Submitted: December 22, 2009
Results First Posted: January 27, 2010
Last Update Posted: July 25, 2014
Last Verified: July 2014

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
Metabolic Diseases
Denosumab
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs