A Randomized Controlled Trial of a Bone Density Decision... | NCT00285168

Studies
A Randomized Controlled Trial of a Bone Density Decision Aide

NCT00285168

Sponsor

University of Manitoba

Status

Terminated

Last Update Posted

Jul 20, 2012Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Osteoporosis

Interventions

Bone Density Decision Aide

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inadequate recruitment

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 30, 2006

First Submission Date that Met QC Criteria

Jan 30, 2006

First Posted Date

Feb 1, 2006Estimated

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

Jul 18, 2012

Last Update Posted Date

Jul 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

William D. Leslie, Professor of Medicine and Radiology, University of ManitobaPrincipal Investigator

Lead Sponsor

University of ManitobaOTHER

Collaborators

Not provided

Description Module

Brief Summary

This research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis.

Detailed Description

This observational research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis. Physicians who only receive the conventional BMD reports without the supplemental information will be the control group.

To compare the rates of pharmacological interventions for osteoporosis in post-menopausal women, family / primary care physicians are randomized to receive either:(i) a conventional BMD report (absolute bone density, T-score result, Z-score result, qualitative statement indicating the BMD results classification of risk for fracture from osteoporosis according to the World Health Organization (WHO) criteria) versus (ii) a conventional BMD report plus a supplemental information sheet (all the information contained in the conventional BMD report plus five-year estimated risks for future fractures calculated from the physician-supplied clinical risk factors and - for those who have osteoporosis according to the WHO criteria - the number needed to treat (in person years) to prevent one fracture.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 - Control		Usual Bone Density Report
2 - Intervention		Bone Density Report with Absolute 10-year Fracture Risk Decision Aide	Behavioral: Bone Density Decision Aide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone Density Decision Aide	Behavioral	Absolute 10-year Fracture Risk Report	2 - Intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

physicians involved in referring patients for DXA bone density testing

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients of physicians involved in referring patients for DXA bone density testing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William D Leslie, MD FRCPC	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Boniface General Hospital		Winnipeg	Manitoba	R2H 2A6	Canada

Label	URL
Province of Manitoba BMD Program	View source

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D050723	Fractures, Bone

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