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

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00091793

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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: Osteoporosis

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

The primary efficacy endpoint is the percent change from baseline in the lumbar spine BMD at 24 months of treatment. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary efficacy endpoints include the following: Percent change from baseline in BMD of the total hip, femoral neck, trochanter, distal 1/3 radius, and total body at 24 months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Percent change from baseline in trabecular, cortical, and total volumetric BMD of the distal radius as measured by QCT at 24 months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Safety endpoints include the following: Adverse event incidence by system organ class and preferred term during the first month 24 and over the entire 48 month [ Time Frame: 48 Months ] [ Designated as safety issue: Yes ]
Safety laboratory analytes (serum chemistry, hematology) at each visit and shifts between baseline and the worst on-study value [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
Subject incidence of anti-denosumab antibody appearance (Negative/Positive) during the first 24 months [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Changes in vital signs [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Changes from baseline at each visit and shifts between baseline and the most extreme on-study QTc interval and other intervals as deemed appropriate, and incidence of clinically significant abnormal ECG results [ Time Frame: 48 months ] [ Designated as safety issue: No ]

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
AMG 162: Experimental 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: Placebo Comparator 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 [BMD] 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

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.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040132
Study First Received:	September 17, 2004
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00091793 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Osteoporosis
Postmenopausal

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 05, 2009