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 is ongoing, but not recruiting participants.

First Received: February 17, 2006 Last Updated: February 20, 2008 History of Changes

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00293813

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: Denosumab Drug: Alendronate	Phase II

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Fosamax Denosumab

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:

Percent change in the distal radius measurements as determined by Xtreme CT from baseline to 12 months. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change at 6 and 12 months in various measures of bone parameters. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	247
Study Start Date:	May 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental denosumab and placebo for alendronate	Drug: Denosumab denosumab 60 mg SC q 6 mos
2: Active Comparator Placebo for denosumab and alendronate	Drug: Alendronate Alendronate 70 mg PO QW

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293813

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050179
Study First Received:	February 17, 2006
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00293813 History of Changes
Health Authority:	Argentina: Ministry of Health; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; 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)

Keywords provided by Amgen:

Post Menopausal
Osteoporosis
MicroCT
Amgen
denosumab

Extreme CT
XCT
Fosamax
Alendronate

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Menopause

Additional relevant MeSH terms:

Musculoskeletal Diseases
Alendronate
Physiological Effects of Drugs
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009