Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00091793

First received: September 17, 2004

Last updated: December 22, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2004

Last Updated Date

December 22, 2010

Start Date ^ICMJE

August 2004

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00091793 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Postmenopausal Osteoporosis

Intervention ^ICMJE

Drug: AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Drug: Placebo
Placebo given at day 1, month 6, month 12 and month 18

Study Arm (s)

Experimental: AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18

Intervention: Drug: AMG 162
Placebo Comparator: Placebo
Placebo given day 1, month 6, month 12 and month 18

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

332

Completion Date

March 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Eligibility Criteria

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

Gender

Female

Ages

up to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00091793

Other Study ID Numbers ^ICMJE

20040132

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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