Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285168
Status:
TERMINATED
Last Update Posted:
2012-07-20
First Post:
2006-01-30
Brief Title:
A Randomized Controlled Trial of a Bone Density Decision Aide
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
A Randomized Controlled Trial of a Bone Density Decision Aide in the Pharmacological Management of Osteoporosis
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is being conducted to determine if a modified bone mineral density BMD test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy It is hypothesized that this supplementary information provided in addition to the conventional BMD report will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis
Detailed Description:
This observational research study is being conducted to determine if a modified bone mineral density BMD test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy It is hypothesized that this supplementary information provided in addition to the conventional BMD report will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis Physicians who only receive the conventional BMD reports without the supplemental information will be the control group
To compare the rates of pharmacological interventions for osteoporosis in post-menopausal women family primary care physicians are randomized to receive eitheri a conventional BMD report absolute bone density T-score result Z-score result qualitative statement indicating the BMD results classification of risk for fracture from osteoporosis according to the World Health Organization WHO criteria versus ii a conventional BMD report plus a supplemental information sheet all the information contained in the conventional BMD report plus five-year estimated risks for future fractures calculated from the physician-supplied clinical risk factors and - for those who have osteoporosis according to the WHO criteria - the number needed to treat in person years to prevent one fracture
To compare the rates of pharmacological interventions for osteoporosis in post-menopausal women family primary care physicians are randomized to receive eitheri a conventional BMD report absolute bone density T-score result Z-score result qualitative statement indicating the BMD results classification of risk for fracture from osteoporosis according to the World Health Organization WHO criteria versus ii a conventional BMD report plus a supplemental information sheet all the information contained in the conventional BMD report plus five-year estimated risks for future fractures calculated from the physician-supplied clinical risk factors and - for those who have osteoporosis according to the WHO criteria - the number needed to treat in person years to prevent one fracture
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