A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00480766
First received: May 30, 2007
Last updated: December 2, 2013
Last verified: December 2013
  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 3

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 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 173
Study Start Date: July 2001
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00480766     History of Changes
Other Study ID Numbers: 0217-193, 2007_560
Study First Received: May 30, 2007
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Glucocorticoid

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014