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ISRCTN
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ISRCTN88402931
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ClinicalTrials.gov identifier
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NCT00152321
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Public title
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Strategies Targeting Osteoporosis to Prevent recurrent Fractures
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Scientific title
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Acronym
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STOP-Fracture Study
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Serial number at source
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CIHR-MOP #62906
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Study hypothesis
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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).
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Lay summary
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Ethics approval
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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).
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Fragility fracture patients with osteoporosis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2003
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Anticipated end date
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30/05/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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220
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Interventions
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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.
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Primary outcome measure(s)
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The proportion of patients starting bisphosphonate treatment within 6 months of fracture
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-62906)
2. Alberta Heritage Foundation for Medical Research (AHFMR) (Canada) - in the form of salary support for investigator(s)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18299546
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Contact name
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Dr
Sumit
Majumdar
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Address
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2E3.07 WMC
University of Alberta Hospital
8440-112th Street
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City/town
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Edmonton, Alberta
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Zip/Postcode
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T6G 2B7
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Country
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Canada
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Tel
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+1 780 407 1399
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Email
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me2.majumdar@ualberta.ca
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Sponsor
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University of Alberta, Research Services Office (Canada)
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Address
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222 Campus Tower
8625 - 112 Street NW
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City/town
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Edmonton
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Zip/Postcode
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AB T6G
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Country
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Canada
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Tel
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+1 780 492 5787
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Fax
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+1 780 492 0949
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Email
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loreesa.tenove@ualberta.ca
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Date applied
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27/08/2005
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Last edited
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28/10/2008
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Date ISRCTN assigned
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09/09/2005
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