Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152321
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2005-09-07
Brief Title:
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures STOP Study
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Background Osteoporosis leads to decreased bone mass skeletal fragility and fractures Fractures cause disability deformity and even death Osteoporosis affects 14 million Canadians 25 of women and 12 of men 50 years Current guidelines recommend aggressive secondary prevention in patients with osteoporosis and a fracture because risk of re-fracture is as high as 20 within a year and because treatment can reduce this risk by 40-50 Because bisphosphonates are safe and efficacious in preventing both vertebral and nonvertebral fractures they are the treatment of choice Patients with a wrist fracture are ideally suited to a strategy of case-finding and secondary prevention since this is a sentinel event in the natural history of osteoporosis wrist fractures are common and easily diagnosed always present to medical attention are usually related to low bone mass and wrist fractures tend to occur years before the more devastating fractures of the hip or vertebrae However these patients are under-diagnosed and under-treated Eight studies have reported that one year after a wrist fracture fewer than 10-20 of patients 50years of age have been tested or treated for osteoporosis A significant care gap between evidence-based best practice and usual care exists
Objective To improve the quality of care for patients with osteoporosis and wrist fractures
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
Specific Aims To determine whether the proposed intervention can
Aim 1- Increase use of effective osteoporosis treatment in patients with a fracture of the wrist
Aim 2- Increase rates of bone mineral density testing in these patients
Aim 3- Increase osteoporosis-related knowledge in these patients
Aim 4- Increase satisfaction with medical care in these patients
Study Design A prospective randomized controlled trial comparing the proposed intervention to usual care in Emergency Departments and Fracture Clinics Eligible patients will be 50 years and present with any wrist fracture and not be taking bisphosphonates Primary outcome is the proportion of patients starting bisphosphonate treatment within 6 months of fracture The main secondary outcomes are starting any effective osteoporosis treatment bisphosphonates calcitonin raloxifene or hormone replacement therapy and bone mineral density testing within 6 months There will be blinded ascertainment of all outcomes The intervention is expected to increase the primary outcome bisphosphonate treatment by at least 20 over usual care rates of 10 With an alpha005 beta090 and a 20 loss to followup the minimum required sample size is 220 patients
Objective To improve the quality of care for patients with osteoporosis and wrist fractures
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
Specific Aims To determine whether the proposed intervention can
Aim 1- Increase use of effective osteoporosis treatment in patients with a fracture of the wrist
Aim 2- Increase rates of bone mineral density testing in these patients
Aim 3- Increase osteoporosis-related knowledge in these patients
Aim 4- Increase satisfaction with medical care in these patients
Study Design A prospective randomized controlled trial comparing the proposed intervention to usual care in Emergency Departments and Fracture Clinics Eligible patients will be 50 years and present with any wrist fracture and not be taking bisphosphonates Primary outcome is the proportion of patients starting bisphosphonate treatment within 6 months of fracture The main secondary outcomes are starting any effective osteoporosis treatment bisphosphonates calcitonin raloxifene or hormone replacement therapy and bone mineral density testing within 6 months There will be blinded ascertainment of all outcomes The intervention is expected to increase the primary outcome bisphosphonate treatment by at least 20 over usual care rates of 10 With an alpha005 beta090 and a 20 loss to followup the minimum required sample size is 220 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR-MOP 62906 | None | None | None |