Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

• ClinicalTrials.gov Identifier: NCT00091793
• Recruitment Status: Completed
• First Posted: September 21, 2004
• Results First Posted: January 26, 2010
• Last Update Posted: December 31, 2010
• Sponsor: Amgen
• Information provided by: Amgen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postmenopausal Osteoporosis	Drug: AMG 162; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 332 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
• Study Start Date: August 2004
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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).
7. 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).
8. 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).

Eligibility Criteria

• Ages Eligible for Study: up to 90 Years (Child, Adult, Older Adult)
• Sexes 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

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

Notice regarding posted summaries of trial results 

Publications of Results:

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. doi: 10.1210/jc.2007-2814. 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. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.

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. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.

• Responsible Party: Global Development Leader, Amgen Inc.
• ClinicalTrials.gov Identifier: NCT00091793
• Other Study ID Numbers: 20040132
• First Posted: September 21, 2004
• Results First Posted: January 26, 2010
• Last Update Posted: December 31, 2010
• Last Verified: December 2010

Keywords provided by Amgen:

Osteoporosis; Postmenopausal

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Denosumab; Bone Density Conservation Agents; Physiological Effects of Drugs