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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18299546
Publication citations
-
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.