Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

September 13, 2006

Start Date ^ICMJE

March 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00175175 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
Proportion in receipt of a BMD test at 6 months and 12 months
Proportion still adherent to osteoporosis treatments at 6 months and 12 months
Proportion of patients with recurrent fractures at 6 months and 12 months
Cost effectiveness analyses

Original Secondary Outcome Measures ^ICMJE

1. Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
2. Proportion in receipt of a BMD test at 6 months and 12 months
3. Proportion still adherent to osteoporosis treatments at 6 months and 12 months
4. Proportion of patients with recurrent fractures at 6 months and 12 months
5. Cost effectiveness analyses

Descriptive Information

Brief Title ^ICMJE

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Official Title ^ICMJE

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoporosis
Hip Fracture

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

220

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00175175

Responsible Party

Study ID Numbers ^ICMJE

AHFMR #200100791

Study Sponsor ^ICMJE

University of Alberta

Collaborators ^ICMJE

Alberta Heritage Foundation for Medical Research
Royal Alexandra Hospital

Investigators ^ICMJE

Principal Investigator:

Sumit R Majumdar, MD, MPH

University of Alberta

Information Provided By

University of Alberta

Verification Date

September 2006

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