Clinical trial NCT03642808: Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study
Official title: Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study Based on a Rheumatology-rehabilitation Collaboration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporotic Fractures
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Hôpital Sainte-Marie Paris
First posted: 2018-08-22
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance and satisfaction of patients with reinforced medical care
timeFrame: 2 months
measure: Satisfaction of health professionals with reinforced medical care: questionnaire.
timeFrame: 2 months
Secondary outcomes:
measure: Number of news falls
timeFrame: 1 year
measure: Number of new osteoporotic fractures
timeFrame: 1 year
measure: Number of new hospitalizations
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Agnès PORTIER, MD
role: PRINCIPAL_INVESTIGATOR
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