MK0822 Clinical Study in Patients With Involutional Osteoporosis (0822-022)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00620113
First received: January 29, 2008
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to examine the effects of a new experimental medication in patient with involutional osteoporosis


Condition Intervention Phase
Osteoporosis Postmenopausal
Drug: odanacatib
Dietary Supplement: cholecalciferol
Dietary Supplement: calcium carbonate
Drug: Comparator: Placebo (unspecified)
Phase 2

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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK0822 in the Treatment of Involutional Osteoporosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in lumber spine bone mineral density (BMD) in patients taking MK0822 (Odanacatib) compared to placebo. [ Time Frame: Over 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in total hip, femoral neck, trochanter bone mineral density (BMD) in patients taking MK0822 (Odanacatib) compared to placebo. [ Time Frame: Over 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
odanacatib 10 mg; cholecalciferol; calcium
Drug: odanacatib
Odanacatib 10 mg; 25 mg; 50 mg once weekly for 52 weeks.
Dietary Supplement: cholecalciferol
cholecalciferol 5600 IU once weekly for 52 weeks.
Dietary Supplement: calcium carbonate
calcium carbonate 500 mg daily for 52 weeks.
Experimental: 2
odanacatib 25 mg; cholecalciferol; calcium
Drug: odanacatib
Odanacatib 10 mg; 25 mg; 50 mg once weekly for 52 weeks.
Dietary Supplement: cholecalciferol
cholecalciferol 5600 IU once weekly for 52 weeks.
Dietary Supplement: calcium carbonate
calcium carbonate 500 mg daily for 52 weeks.
Experimental: 3
odanacatiab 50 mg; cholecalciferol; calcium
Drug: odanacatib
Odanacatib 10 mg; 25 mg; 50 mg once weekly for 52 weeks.
Dietary Supplement: cholecalciferol
cholecalciferol 5600 IU once weekly for 52 weeks.
Dietary Supplement: calcium carbonate
calcium carbonate 500 mg daily for 52 weeks.
Placebo Comparator: 4
placebo; cholecalciferol; calcium
Dietary Supplement: cholecalciferol
cholecalciferol 5600 IU once weekly for 52 weeks.
Dietary Supplement: calcium carbonate
calcium carbonate 500 mg daily for 52 weeks.
Drug: Comparator: Placebo (unspecified)
Odanacatib Placebo once weekly for 52 weeks.

  Eligibility

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

Inclusion Criteria:

  • Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
  • Patient who has low bone mineral density
  • Patient has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip
  • Patient is ambulatory (can walk)

Exclusion Criteria:

  • Patient has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia
  • Patient has received osteoporosis medications or other medications that affect bone
  • Patient is already participating in another drug study
  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: NCT00620113

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00620113     History of Changes
Other Study ID Numbers: 0822-022, MK0822-022, 2007_034
Study First Received: January 29, 2008
Last Updated: December 16, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Cholecalciferol
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 19, 2014