A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00480766

Purpose

A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss.

Condition	Intervention	Phase
Osteoporosis	Drug: MK0217/Duration of Treatment : 12 Months	Phase III

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Alendronate sodium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of Oral Alendronate Sodium Once Weekly for the Prevention and Treatment of Glucocorticoid-Induced Bone Loss

Further study details as provided by Merck:

Primary Outcome Measures:

Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo

Secondary Outcome Measures:

Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months

Estimated Enrollment:	150
Study Start Date:	July 2001

Eligibility

Criteria

Inclusion Criteria:

Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture

Exclusion Criteria:

Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease, hypertension, upper gastrointestinal disease, cancer, being treated with hormone replacement therapy, or life expectancy of less than 3 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480766

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2007_560
Study First Received:	May 30, 2007
Last Updated:	May 30, 2007
ClinicalTrials.gov Identifier:	NCT00480766
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Glucocorticoid

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 13, 2009