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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480766
• Other study ID #: 0217-193
• Secondary ID: 2007_560
• Status: Completed
• Phase: Phase 3
• Start date: July 2001
• Est. completion date: August 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• MK0217/Duration of Treatment : 12 Months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months