Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Osteoporosis Clinical Trial

Official title:

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175175
• Other study ID #: AHFMR #200100791
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: September 13, 2006
• Start date: March 2002

Study information

• Verified date: September 2006
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.

We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.

Description:

Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.

We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• hip fracture patient > 50 years of age

• able to give consent (or proxy consent available)

• lives within health region

• no contraindications to bisphosphonate therapy

Exclusion Criteria:

• refuses to participate or consent

• dementia or delirium without a proxy consent available

• nursing home or longterm care

• pathologic fracture

• chronic glucocorticoid use

• already receiving prescription osteoporosis treatment (calcium and vitamin D do not preclude inclusion)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Osteoporosis

Intervention

Behavioral:
• Allied health professional-run osteoporosis service ("case-management")

Locations

Country	Name	City	State
Canada	University of Alberta Hospitals	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research, Royal Alexandra Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
Secondary	Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
Secondary	Proportion in receipt of a BMD test at 6 months and 12 months
Secondary	Proportion still adherent to osteoporosis treatments at 6 months and 12 months
Secondary	Proportion of patients with recurrent fractures at 6 months and 12 months
Secondary	Cost effectiveness analyses