Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.

Not Applicable

Completed

• Conditions: Osteoporosis, Management Care, Fracture
• Interventions: Behavioral: Coordinator-based post fracture program

• Registration Number: NCT02060747
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Primary Completion: 2016-10-07
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Men and women over 45 years
• Fragility wrist and hip fractures
• Volunteer

Exclusion Criteria

• Public route accident
• Emergency illness associated
• Short life expectancy
• Not volunteer
• Bedridden patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coordinator-based post fracture program	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).

Primary Outcome Measures

Name	Time	Method
Percentage of patient with a correct management care.	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).

Secondary Outcome Measures

Name	Time	Method
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).	6 months

Trial Locations

Locations (1)

Groupe hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France