MK0822 (Odanacatib) Late Phase II Dose-Finding Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00620113

Purpose

The purpose of this study is to examine the effects of a new experimental medication MK0822 (Odanacatib) in patients with involutional osteoporosis.

Condition	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: Odanacatib Drug: Comparator: Placebo (unspecified) Dietary Supplement: cholecalciferol Dietary Supplement: calcium carbonate	Phase II

MedlinePlus related topics: Calcium Dietary Supplements Osteoporosis

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate Cholecalciferol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK0822 (Odanacatib) in The Treatment of Involutional Osteoporosis

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 ]

Estimated Enrollment:	280
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.
2: 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.
3: Experimental 3: odanacatib 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.
4: Placebo Comparator 4: placebo; cholecalciferol; calcium.	Drug: Comparator: Placebo (unspecified) Odanacatib Placebo 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.

Eligibility

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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_034, MK0822-022
Study First Received:	January 29, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00620113
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Calcium, Dietary
Cholecalciferol
Signs and Symptoms
Vitamin D
Musculoskeletal Diseases
Ergocalciferols

Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Calcium Carbonate
Bone Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Antacids
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009