Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postmenopausal Osteoporosis	Drug: AMG 162 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals Osteoporosis

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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).

Enrollment:	332
Study Start Date:	August 2004
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	up to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Eligibility Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091793

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

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

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

Publications:

Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. Epub 2008 Apr 1.

Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. Epub 2009 Apr 2.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. Epub 2011 Feb 2.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00091793 History of Changes
Other Study ID Numbers:	20040132
Study First Received:	September 17, 2004
Results First Received:	December 22, 2009
Last Updated:	December 22, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Osteoporosis
Postmenopausal

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 21, 2013