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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00729183
First received: August 4, 2008
Last updated: May 14, 2012
Last verified: May 2012
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

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 July 22, 2014