The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.

Osteoporosis Clinical Trial

Official title:

A Six Month Double-Blind, Placebo-Controlled Trial Followed by Six Month Open-Label Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00346190
• Other study ID #: CA-16
• Status: Recruiting
• Phase: Phase 3
• First received: June 27, 2006
• Last updated: April 11, 2007
• Start date: January 2003
• Est. completion date: April 2007

Study information

• Verified date: January 2006
• Source: McGill University Health Center
• Contact: Richard Kremer, MD PhD
• Phone: 514-934-1934
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To determine whether administration of Alendronate early is more effective than late in the prevention of osteoporosis following a hip fracture

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

Male and Female aged > 55 Low trauma hip fracture up to 90 days Be willing to submit to periodic bone mineral density radiographic studies of the spine & 24 hr urine collection Written informed consent

Exclusion Criteria:

• Disorders known to affect bone metabolism Not taking bisphosphonates within last 6 months Drugs known to interfere with calcium metabolism within the lats 6 months prior to hip fracture serum calcium> 2.65 mmol/L Treatment with any investigational drug within the last 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hip Fractures
• Osteoporosis

Intervention

Drug:
• Alendronate

Locations

Country	Name	City	State
Canada	Mcgill University Health center	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Merck Frosst Canada Ltd.

Country where clinical trial is conducted

Canada,