Strategies Targeting Osteoporosis to Prevent recurrent Fractures

ISRCTN	ISRCTN88402931
DOI	https://doi.org/10.1186/ISRCTN88402931
ClinicalTrials.gov (NCT)	NCT00152321
Protocol serial number	CIHR-MOP #62906
Sponsor	University of Alberta, Research Services Office (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-62906), Alberta Heritage Foundation for Medical Research (AHFMR) (Canada) - in the form of salary support for investigator(s)

Submission date: 27/08/2005
Registration date: 09/09/2005
Last edited: 28/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sumit Majumdar
Scientific

2E3.07 WMC
University of Alberta Hospital
8440-112th Street
Edmonton, Alberta
T6G 2B7
Canada

Phone	+1 780 407 1399
Email	me2.majumdar@ualberta.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	STOP-Fracture Study
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The proportion of patients starting bisphosphonate treatment within 6 months of fracture
Key secondary outcome measure(s)	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
Completion date	30/05/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	220
Key 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
Key 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
Date of first enrolment	01/09/2003
Date of final enrolment	30/05/2006

Locations

Countries of recruitment

Canada

Study participating centre

2E3.07 WMC

Edmonton, Alberta
T6G 2B7
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/02/2008		Yes	No