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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00729183
First received: August 4, 2008
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  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 3

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:

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 ]

Enrollment: 214
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 by Merck

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

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00729183     History of Changes
Other Study ID Numbers: MK-0822-031, 2005_023
Study First Received: August 4, 2008
Last Updated: May 14, 2012
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 May 19, 2013