Strategies Targeting Osteoporosis to Prevent recurrent Fractures
| ISRCTN | ISRCTN88402931 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88402931 |
| ClinicalTrials.gov number | NCT00152321 |
| Secondary identifying numbers | CIHR-MOP #62906 |
- 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
Scientific
2E3.07 WMC
University of Alberta Hospital
8440-112th Street
Edmonton, Alberta
T6G 2B7
Canada
| Phone | +1 780 407 1399 |
|---|---|
| me2.majumdar@ualberta.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | 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 study start date | 01/09/2003 |
| Completion date | 30/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
T6G 2B7
Canada
Sponsor information
University of Alberta, Research Services Office (Canada)
University/education
University/education
222 Campus Tower
8625 - 112 Street NW
Edmonton
AB T6G
Canada
| Phone | +1 780 492 5787 |
|---|---|
| loreesa.tenove@ualberta.ca | |
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-62906)
No information available
Alberta Heritage Foundation for Medical Research (AHFMR) (Canada) - in the form of salary support for investigator(s)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
