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

NCT ID: NCT03642808

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2023-12-31

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.

Conditions

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Osteoporotic Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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rehabilitation program

* 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

Group Type EXPERIMENTAL

rehabilitation program

Intervention Type OTHER

Availibility of patients to complete a rehabilitation program during 8 weeks and to come back 4 times for a careful medical examination

Interventions

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rehabilitation program

Availibility of patients to complete a rehabilitation program during 8 weeks and to come back 4 times for a careful medical examination

Intervention Type OTHER

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Sainte-Marie Paris

UNKNOWN

Sponsor Role collaborator

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnès PORTIER, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

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Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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McLellan AR, Gallacher SJ, Fraser M, McQuillian C. The fracture liaison service: success of a program for the evaluation and management of patients with osteoporotic fracture. Osteoporos Int. 2003 Dec;14(12):1028-34. doi: 10.1007/s00198-003-1507-z. Epub 2003 Nov 5.

Reference Type RESULT
PMID: 14600804 (View on PubMed)

Briot K, Cortet B, Thomas T, Audran M, Blain H, Breuil V, Chapuis L, Chapurlat R, Fardellone P, Feron JM, Gauvain JB, Guggenbuhl P, Kolta S, Lespessailles E, Letombe B, Marcelli C, Orcel P, Seret P, Tremollieres F, Roux C. 2012 update of French guidelines for the pharmacological treatment of postmenopausal osteoporosis. Joint Bone Spine. 2012 May;79(3):304-13. doi: 10.1016/j.jbspin.2012.02.014. Epub 2012 Apr 19.

Reference Type RESULT
PMID: 22521109 (View on PubMed)

Campbell AJ, Borrie MJ, Spears GF. Risk factors for falls in a community-based prospective study of people 70 years and older. J Gerontol. 1989 Jul;44(4):M112-7. doi: 10.1093/geronj/44.4.m112.

Reference Type RESULT
PMID: 2738307 (View on PubMed)

Karlsson MK, Magnusson H, von Schewelov T, Rosengren BE. Prevention of falls in the elderly--a review. Osteoporos Int. 2013 Mar;24(3):747-62. doi: 10.1007/s00198-012-2256-7. Epub 2013 Jan 8.

Reference Type RESULT
PMID: 23296743 (View on PubMed)

Briot K. Fracture Liaison Services. Curr Opin Rheumatol. 2017 Jul;29(4):416-421. doi: 10.1097/BOR.0000000000000401.

Reference Type RESULT
PMID: 28426444 (View on PubMed)

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type RESULT
PMID: 1593914 (View on PubMed)

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

Reference Type RESULT
PMID: 5349366 (View on PubMed)

KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

Reference Type RESULT
PMID: 14044222 (View on PubMed)

Byles JE, Leigh L, Vo K, Forder P, Curryer C. Life space and mental health: a study of older community-dwelling persons in Australia. Aging Ment Health. 2015;19(2):98-106. doi: 10.1080/13607863.2014.917607. Epub 2014 Jun 6.

Reference Type RESULT
PMID: 24903196 (View on PubMed)

Ibrahim A, Singh DKA, Shahar S. 'Timed Up and Go' test: Age, gender and cognitive impairment stratified normative values of older adults. PLoS One. 2017 Oct 3;12(10):e0185641. doi: 10.1371/journal.pone.0185641. eCollection 2017.

Reference Type RESULT
PMID: 28972994 (View on PubMed)

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

Reference Type RESULT
PMID: 1202204 (View on PubMed)

Other Identifiers

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OPTICHUTE

Identifier Type: -

Identifier Source: org_study_id

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