An interventional study of Coordinator-based post fracture program in Osteoporosis, Management Care, Fracture, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 45 Years to 95 Years. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Supportive care
Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears".
The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as "Fracture Liaison Service" (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) "Osteoporosis Coordinator Program" (Canada [9,10]) or "Care Manager Programs" (USA [11,12]).
The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures.
Men and women are included aged over 45 years with fragility wrist and hip fractures.
Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls.
Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months
1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.
This study's enrollment of 480 is above the median of 95 across 1,152 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 344 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
The intervention arm deals with the intervention of a nurse trained in the management of osteoporosis fractures assisted by a clinical research technician who will manage the logistics and reglementary aspects of the study (patient enrollment, quality and study proceedings).
Behavioral: Coordinator-based post fracture program
Percentage of patient with a correct management care.
This outcome is a composite outcome wich differ with each fracture type. It will be assess 6 months after patient inclusion. An adequate management care is defined for each fracture as below. * For wrist fracture: medical visit at J15, osteodensitometry, therapeutic decision if necessary (if not, reasons have to be precised in medical sheet). * For hip fracture: osteodensitometry if necessary, therapeutic (chronic care) decision if necessary (if not, reasons have to be precised in medical sheet).
Time frame: 6 months
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).
Time frame: 6 months
Number of rehospitalisation for fracture.
Time frame: 6 months
Number of falls over 6 months post-inclusion.
Time frame: 6 months
Plan to share: Undecided
Ran from Jul 2013 to primary completion in Oct 2016, 39 months.
Of 228 non-industry interventional studies with no phase under Osteoporosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's 39 months is above that.
Counting every sponsor, half of 246 studies reached it within 22 months; a quarter within 9 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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