Randomized Trial of Osteoporosis Intervention Strategies... | NCT00175175

Studies
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

NCT00175175

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Sep 15, 2006Estimated

Enrollment

220

Phase

Not Applicable

Conditions

Osteoporosis
Hip Fracture

Interventions

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

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2006

Last Update Posted Date

Sep 15, 2006Estimated

Name	Class
Alberta Heritage Foundation for Medical Research	OTHER
Royal Alexandra Hospital	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220

Name	Type	Description	Arm Group Labels	Other Names
Allied health professional-run osteoporosis service ("case-management")	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sumit R Majumdar, MD, MPH	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospitals		Edmonton	Alberta	T6G 2B7	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19177538	Derived	Morrish DW, Beaupre LA, Bell NR, Cinats JG, Hanley DA, Harley CH, Juby AG, Lier DA, Maksymowych WP, Majumdar SR. Facilitated bone mineral density testing versus hospital-based case management to improve osteoporosis treatment for hip fracture patients: additional results from a randomized trial. Arthritis Rheum. 2009 Feb 15;61(2):209-15. doi: 10.1002/art.24097.
19139320

ID	Term
D010024	Osteoporosis
D006620	Hip Fractures

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
D010347	Patient Care Planning
D003191	Comprehensive Health Care
D010346	Patient Care Management
D006298	Health Services Administration