MK0822 Clinical Study in Patients With Involutional Osteoporosis - 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 in patient with involutional osteoporosis

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

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 in the Treatment of Involutional Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Supplements Diets 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 ]

Estimated Enrollment:	280
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental odanacatib 10 mg; cholecalciferol; calcium	Drug: odanacatib Odanacatib 10 mg; 25 mg; 50 mg once weekly for 52 weeks. Dietary Supplement: Comparator: cholecalciferol cholecalciferol 5600 IU once weekly for 52 weeks. Dietary Supplement: Comparator: calcium carbonate calcium carbonate 500 mg daily for 52 weeks.
2: Experimental odanacatib 25 mg; cholecalciferol; calcium	Drug: odanacatib Odanacatib 10 mg; 25 mg; 50 mg once weekly for 52 weeks. Dietary Supplement: Comparator: cholecalciferol cholecalciferol 5600 IU once weekly for 52 weeks. Dietary Supplement: Comparator: calcium carbonate calcium carbonate 500 mg daily for 52 weeks.
3: Experimental odanacatiab 50 mg; cholecalciferol; calcium	Drug: odanacatib Odanacatib 10 mg; 25 mg; 50 mg once weekly for 52 weeks. Dietary Supplement: Comparator: cholecalciferol cholecalciferol 5600 IU once weekly for 52 weeks. Dietary Supplement: Comparator: calcium carbonate calcium carbonate 500 mg daily for 52 weeks.
4: Placebo Comparator placebo; cholecalciferol; calcium	Dietary Supplement: Comparator: cholecalciferol cholecalciferol 5600 IU once weekly for 52 weeks. Dietary Supplement: Comparator: 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:

Female Patients Over 18 Years Old
Confirmed SLE Diagnosis According To ACR
Signed ICF

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:	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:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00620113 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Cholecalciferol
Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Trace Elements
Calcium Carbonate
Bone Diseases
Signs and Symptoms

Calcium, Dietary
Musculoskeletal Diseases
Vitamin D3
Vitamins
Osteoporosis, Postmenopausal
Antacids
Calciferol
Micronutrients

Additional relevant MeSH terms:

Cholecalciferol
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Calcium Carbonate

Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Vitamins
Osteoporosis, Postmenopausal
Antacids
Micronutrients

ClinicalTrials.gov processed this record on September 04, 2009