BMD Efficacy and Safety of Odanacatib in Postmenopausal Women - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00729183

Purpose

This study will evaluate the safety and treatment effect of 50 mg MK0822 with Vitamin D vs placebo with Vitamin D in postmenopausal women with low bone density.

Condition	Intervention	Phase
Osteoporosis	Drug: Odanacatib Drug: Comparator: Placebo	Phase III

MedlinePlus related topics: Osteoporosis

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized, Placebo-Controlled Study to Evaluate the Effect of Odanacatib (MK0822) on Bone Mineral Density (BMD) and Overall Safety, and to Estimate the Effect of Odanacatib (MK0822) on Bone Micro-Architecture in Postmenopausal Women Treated With Vitamin D

Further study details as provided by Merck:

Primary Outcome Measures:

To assess the safety and tolerability of MK0822 50 mg as compared with placebo [ Time Frame: 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the percent change from baseline in areal BMD at the lumbar spine (assessed by DXA) [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0822 (odanacatib)	Drug: Odanacatib Odanacatib 50 mg tablets once weekly, Vitamin D3 tablets 5600 IU once weekly and Calcium supplements 1200 mg daily. Treatment period of 24 months.
2: Placebo Comparator Placebo	Drug: Comparator: Placebo Placebo tablets once weekly, Vitamin D3 tablets 5600 IU once weekly and Calcium Supplements 1200 mg once daily. Treatment period of 24 months.

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal for 3 years, t-score <=-1.5 but >-3.5, hips contain no hardware from orthopedic procedures, ambulatory

Exclusion Criteria:

Patient has had a previous hip fracture
Patient has had >1 prior clinical vertebral fracture
Patient has been treated with oral bisphosponates, strontium, PTH or other agents with an effect on bone
Patient has had metabolic bone disorder other than osteoporosis
Patient has renal stones, Parkinson's disease, MS or active parathyroid disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729183

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information	Recruiting
Walnut Creek, California, United States, 94598
Call for Information	Recruiting
San Francisco, California, United States, 94107
Call for Information	Recruiting
Greenbrae, California, United States, 94904
Australia
Merck Sharp & Dohme (Australia) Pty Ltd.	Recruiting
South Granville, Australia, NSW 2142
Contact: David Woolner 64-9-523-6075
Canada, Quebec
Merck Frosst Canada Ltd.	Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Michel Cimon 514-428-2605
Denmark
Merck Sharp & Dohme	Recruiting
Glostrup, Denmark, 2600
Contact: Christina Wengel 45-43-28-77-90
France
Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
Paris Cedex 8, France, 75114
Contact: Jean-Marie Goehrs 33-1-4754-89-90

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_539, MK0822-031
Study First Received:	August 4, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00729183
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Cholecalciferol
Vitamin D
Musculoskeletal Diseases

Ergocalciferols
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 13, 2009