BMD Efficacy and Safety of Odanacatib in Postmenopausal Women (0822-031) - Full Text View

Sponsor:	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: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Osteoporosis Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Areal Bone Mass Density at the lumbar spine compared to placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Areal Bone Mass Density at the lumbar spine compared to placebo [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Areal Bone Mass Density at the total hip, femoral neck, hip trochanter and distal forearm (one-third distal and ultra distal sites) compared to placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Areal Bone Mass Density at the total hip, femoral neck, hip trochanter and distal forearm (one-third distal and ultra distal sites) compared to placebo [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	October 2008
Study Completion Date:	March 2011
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK0822	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.
Placebo Comparator: 2 Placebo	Drug: 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 AND is a candidate for osteoporosis therapy
Patient has been treated with oral bisphosphonates, 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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00729183 History of Changes
Other Study ID Numbers:	2008_539, MK0822-031
Study First Received:	August 4, 2008
Last Updated:	April 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012