Trial of Osteoporosis Intervention Strategies in Hip Frac... | NCT00136058

Studies
Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

NCT00136058

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Dec 16, 2011Estimated

Enrollment

250

Phase

Phase 3

Conditions

Osteoporosis

Interventions

bone densitometry (DEXA)
alendronate or risedronate

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

ID	Type	Description	Link
AHFMR 200100791-2

Status Module

Record Verification Date

Dec 2011

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

Jan 2002

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 26, 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

Dec 15, 2011

Last Update Posted Date

Dec 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of AlbertaOTHER

Collaborators

Name	Class
Alberta Heritage Foundation for Medical Research	OTHER

Description Module

Brief 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.

Detailed 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.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of patients who get a BMD and the number who are started on active osteoporosis therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 50 or over; males or females.
Reside in the community or have access to bone densitometry
Hip fracture
Patient can consent or proxy consent available
No contraindications to bisphosphonates

Exclusion Criteria:

Patient refuses consent process
Already receiving active drug therapy for osteoporosis other than calcium and vitamin D
Dementia or delirium
Pathological fracture
Chronic corticosteroid therapy

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
Donald W Morrish, MD, PhD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta	T6G2S2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D006620	Hip Fractures

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015502	Absorptiometry, Photon
D019386	Alendronate
D000068296	Risedronic Acid

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
bone densitometry (DEXA)	Procedure
alendronate or risedronate	Drug