MK0822 Clinical Study in Patients With Involutional Osteoporosis - Full Text View

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:

MedlinePlus related topics: Bone Density Calcium Minerals Osteoporosis

Drug Information available for: Cholecalciferol Calcium Gluconate Calcium carbonate

U.S. FDA Resources

Further study details as provided by Merck:

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:	January 2008
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620113

Sponsors and Collaborators

Merck

Investigators

Study Director:

medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00620113 History of Changes
Other Study ID Numbers:	2007_034, MK0822-022
Study First Received:	January 29, 2008
Last Updated:	November 5, 2009
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 June 17, 2013