Condition category
Musculoskeletal Diseases
Date applied
27/08/2005
Date assigned
09/09/2005
Last edited
28/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sumit Majumdar

ORCID ID

Contact details

2E3.07 WMC
University of Alberta Hospital
8440-112th Street
Edmonton
Alberta
T6G 2B7
Canada
+1 780 407 1399
me2.majumdar@ualberta.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00152321

Protocol/serial number

CIHR-MOP #62906

Study information

Scientific title

Acronym

STOP-Fracture Study

Study hypothesis

An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines).

Ethics approval

University of Alberta Health Research Ethics Board, first approved 1st December 2003, updated annually on anniversary date, most recent 1st December 2006 (ref: HREB#4478).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Fragility fracture patients with osteoporosis

Intervention

Multifaceted intervention that consists of the following: patient specific reminders; single page treatment guidelines generated and endorsed by local opinion leaders; patient education and counseling.
Control group is 'usual care', defined as provision of generic osteoporosis-related educational leaflets at time of fracture.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The proportion of patients starting bisphosphonate treatment within 6 months of fracture

Secondary outcome measures

1. Starting any effective osteoporosis treatment (bisphosphonates, calcitonin, raloxifene, or hormone therapy)
2. Bone mineral density testing
3. Self reported diagnosis of osteoporosis and other knowledge
4. Satisfaction with care
5. Health related quality of life

Overall trial start date

01/09/2003

Overall trial end date

30/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients 50 years of age or older, either sex, with a wrist fracture who present to the Emergency Departments or Fracture Clinics at our two study sites will be eligible for study enrollment.
Specifically:
1. Age 50 years or greater
2. Any distal forearm fracture

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Unable to give simple informed consent
2. Unwilling to participate in the study
3. Unable to understand, read, or converse in English
4. Place of residence outside Capital Health
5. Already receiving osteoporosis treatment with a bisphosphonate
6. Previously documented allergy or intolerance to a bisphosphonate
7. Currently enrolled in the pilot study or other osteoporosis study

Recruitment start date

01/09/2003

Recruitment end date

30/05/2006

Locations

Countries of recruitment

Canada

Trial participating centre

2E3.07 WMC
Edmonton, Alberta
T6G 2B7
Canada

Sponsor information

Organisation

University of Alberta, Research Services Office (Canada)

Sponsor details

222 Campus Tower
8625 - 112 Street NW
Edmonton
AB T6G
Canada
+1 780 492 5787
loreesa.tenove@ualberta.ca

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-62906)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alberta Heritage Foundation for Medical Research (AHFMR) (Canada) - in the form of salary support for investigator(s)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18299546

Publication citations

  1. Results

    Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH, Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial., CMAJ, 2008, 178, 5, 569-575, doi: 10.1503/cmaj.070981.

Additional files

Editorial Notes