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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

May 30, 2007
December 2, 2013
July 2001
August 2003   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00480766 on ClinicalTrials.gov Archive Site
Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months
Same as current
Not Provided
Not Provided
 
A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
Drug: MK0217/Duration of Treatment : 12 Months
Not Provided
Stoch SA, Saag KG, Greenwald M, Sebba AI, Cohen S, Verbruggen N, Giezek H, West J, Schnitzer TJ. Once-Weekly Oral Alendronate 70 mg in Patients with Glucocorticoid-Induced Bone Loss: A 12-Month Randomized, Placebo-Controlled Clinical Trial. J Rheumatol. 2009 Jun 1; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
August 2003
August 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00480766
0217-193, 2007_560
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP