Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

December 22, 2010 updated by: Amgen

A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Eligibility Criteria

- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Drug: AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Placebo Comparator: Placebo
Placebo given day 1, month 6, month 12 and month 18
Drug: Placebo
Placebo given at day 1, month 6, month 12 and month 18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 Months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 Months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
24 Months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 Months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
24 Months
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
24 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
24 months
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
24 months
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 months
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
24 months
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 months
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
24 months
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: 24 months
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 17, 2004

First Submitted That Met QC Criteria

September 20, 2004

First Posted (Estimate)

September 21, 2004

Study Record Updates

Last Update Posted (Estimate)

December 31, 2010

Last Update Submitted That Met QC Criteria

December 22, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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