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

Organon and Co0 sites173 target enrollmentJuly 2001

ConditionsOsteoporosis

DrugsMK0217/Duration of Treatment : 12 Months

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Osteoporosis
Sponsor: Organon and Co
Enrollment: 173
Primary Endpoint: 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
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2001

End Date

August 2003

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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