Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study

Study Overview
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Brief Summary
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Within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), a reinforced medical care of osteoporosis ('Fracture Liaison service') was organized for osteoporotic fractured patients. The evaluation of benefits of this program through a randomized study showed an improvement in diagnostic tests performed (bone densitometry) and antiosteoporotic treatment initiated (OPTIPOST study, being published in BMJ). However, of 323 patients included, 91 presented a new fracture within 12 months. Among them, 40/126 patients (31.7%) were in the reinforced medical care arm. This result clearly demonstrates the need for a specific medical care program for patients with osteoporotic fracture falling regularly.

Detailed Description
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Only few studies for secondary prevention of falls have been conducted in France yet. This can be partly explained by the complexity of reeducation programs to implement and by organization issues. Moreover, to our knowledge, no study has demonstrated the benefit of such programs on secondary prevention of osteoporotic fractures, even though falls prevention is needed. Our objective is to demonstrate with a pilot study the feasibility of a falls secondary prevention program, based on a rheumatology (GHPSJ) and reeducation wards (Hôpital Sainte-Marie Paris : HSMP) collaboration. Considering the innovative nature of both this program and this collaboration, a feasibility study is preferable before conducting a larger multicentric study, evaluating locomoter benefits of this program in comparison with usual primary care.

Official Title
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Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study Based on a Rheumatology-rehabilitation Collaboration

Conditions
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Osteoporotic Fractures

Intervention / Treatment
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* Other: rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women (age ≥ 60 years) Francophone Hospitalized patient or who is consulted in rheumatology or indicated for bone densitometry in Groupe Hospitalier Paris Saint-Joseph, who are suffered a low-energy osteoporotic fracture in the last 12 months Patient with an acceptable handicap level definied by a Timed Up & Go test (TUG) <14 seconds Autonomous patient with instrumental activities of daily living score (4 items) = 0/4 and Activities of Daily Living score (6 items) ≥5.5/6 Patient with medical insurance Exclusion Criteria: History of locomor specialized care for the falls prevention Cognitive impairment/diagnosed dementia or chronic neurological disorder, which doesn't permit the undertanding or a follow-up to a rehabilitation program Fall due to a neurovascular disease or acute cardiovascular Significant comorbidities which don't permit a locomotor rehabilitation care Refusal to participate in the study Refusal to follow the entire rehabilitation program Geographic remoteness which doesn't permit the movement to the rehabilitation center Contreindicated balneotherapy: incontinence, skin disease or cardiovascular disease Patient under guardianship or curatorship Patient deprived of liberty

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rehabilitation program<br>Duration of 8 weeks for a cycle of rehabilitation at the rate of two half-days per week Two interventions per half-day: 30 minutes of education and 1h30 of rehabilitation: physiotherapist, psychomotricity, adapted physical activity | Other: rehabilitation program<br>* Availibility of patients to complete a rehabilitation program during 8 weeks and to come back 4 times for a careful medical examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance and satisfaction of patients with reinforced medical care | compliance and satisfaction of patients with reinforced medical care: compliance questionnaire. Evaluation made for the end of the program of reeducation : EVALUATION OF PATIENT ATTENDANCE (2 questions): How many days did you participate in re-education sessions at the Hôpital Sainte-Marie Paris as part of the OPTICHUTE rehabilitation program? Have you attended all the proposed rehabilitation sessions? (yes/no) EVALUATION OF PATIENT SATISFACTION: possible answer: degree of satisfaction (very satisfied/overall Satisfied/overall dissatisfied/ very dissatisfied) A: concerning the initial medical examination and the organization of your appointments : 2 questions B: concerning the progress of the reeducation sessions: 5 questions C: concerning the rehabilitation program more generally: 5 questions D: overall assessment - free comment | 2 months | 
| Satisfaction of health professionals with reinforced medical care: questionnaire. | Satisfaction of health professionals with reinforced medical care: satisfaction questionnaire. Evaluation made for the end of the program of reeducation Sections A and B and D: Hôpital Sainte-Marie Paris staff, Sections C and D: Groupe Hospitalier Paris Saint Joseph staff 12 questions for the sections A-B-C-D with possible answer: degree of satisfaction (very satisfied/rather satisfied/ rather unhappy/ very dissatisfied) A. Regarding the rehabilitation program B. Regarding patients C. Regarding the inclusion visit D: Concerning the link between the rheumatology department of the Groupe Hospitalier Paris Saint Joseph and the hospital day of Rehabilitation of the Hôpital Sainte-Marie Paris E: Overall assessment: ree comment | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of news falls | Number of new falls within the year following the beginning of the program | 1 year | 
| Number of new osteoporotic fractures | Number of new osteoporotic fractures within the year following the beginning of the program | 1 year | 
| Number of new hospitalizations | Number of new hospitalizations within the year following the beginning of the program | 1 year |