This trial is active, not recruiting.

Condition osteoporosis, management care, fracture
Treatment coordinator-based post fracture program
Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborator Assistance Publique - Hôpitaux de Paris
Start date October 2013
End date February 2016
Trial size 329 participants
Trial identifier NCT02060747, OPTIPOST


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
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).
coordinator-based post fracture program
(No Intervention)

Primary Outcomes

Percentage of patient with a correct management care.
time frame: 6 months

Secondary Outcomes

Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).
time frame: 6 months

Eligibility Criteria

Male or female participants from 45 years up to 95 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Groupe Hospitalier Paris Saint Joseph.