Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture. (OPTIPOST)
|ClinicalTrials.gov Identifier: NCT02060747|
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 23, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis, Management Care, Fracture||Behavioral: Coordinator-based post fracture program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Actual Study Start Date :||July 1, 2013|
|Actual Primary Completion Date :||October 7, 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Coordinator-based post fracture program
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
|No Intervention: standard care|
- Percentage of patient with a correct management care. [ Time Frame: 6 months ]
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).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060747
|Groupe hospitalier Paris Saint-Joseph|
|Paris, France, 75014|