Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Osteoporosis Clinical Trial

Official title: Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Status Completed

Clinical Trial Summary

The objective of this study is to determine if an intervention with a fracture manager to arrange bone densitometry after a hip fracture is more effective in diagnosing and treating osteoporosis when compared to "usual care". "Usual care" consists of no intervention to arrange bone mineral density (BMD) testing or therapy other than what normally occurs in the community. The investigators postulate that a fracture manager will be more effective in getting BMD done and in starting appropriate therapy.

Clinical Trial Description

All hip fracture patients in the Edmonton area will be screened for eligibility (mini-mental status >20, not on active osteoporosis pharmacologic therapy). All patients will have informed consent obtained. Patients will be randomized to 2 groups:

• Group 1: Active intervention. The fracture manager will arrange for bone densitometry (DEXA) to be done 3-6 months after the fracture. If the patient meets standard criteria for osteoporosis, therapy with a bisphosphonate (alendronate or risedronate) will be instituted by the study physicians.

• Group 2: Usual care. Patients will receive basic information about calcium and vitamin D and osteoporosis and told to follow up with their family doctor. At 6 months, patients will be contacted to determine if they have had a BMD done or started on active (drug) osteoporosis therapy. If not, the fracture manager will arrange the BMD and if appropriate therapy will be started by the study physicians.

All patients will be followed for 1 year. The primary endpoints are the number of patients who get a BMD and the number who are started on active osteoporosis therapy. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hip Fractures
• Osteoporosis

• NCT number: NCT00136058
• Study type: Interventional
• Source: University of Alberta
• Status: Completed
• Phase: Phase 3
• Start date: January 2002
• Completion date: April 2006