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Osteoporotic FracturesOPTICHUTENCT03642808

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

A study testing rehabilitation program in people with Osteoporotic Fractures, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), a reinforced medical care of osteoporosis ('Fracture Liaison service') was organized for osteoporotic fractured patients. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Osteoporotic Fractures
What is being tested?
rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteFrance
Study dates
27 Jul 2018to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

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

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.

Read the 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.

Being tested
rehabilitation program
Medical subject headings
Osteoporotic Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rehabilitation programOther

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

Study groups in NCT03642808
Study groupRoleWhat they receive
rehabilitation programExperimental* 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
Receives: Other: rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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):

    1. How many days did you participate in re-education sessions at the Hôpital Sainte-Marie Paris as part of the OPTICHUTE rehabilitation program?
    2. 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

    Measured: 2 months

  2. 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)

    1. 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

    Measured: 2 months

Secondary outcomes (3)

  1. Number of news falls

    Number of new falls within the year following the beginning of the program

    Measured: 1 year

  2. Number of new osteoporotic fractures

    Number of new osteoporotic fractures within the year following the beginning of the program

    Measured: 1 year

  3. Number of new hospitalizations

    Number of new hospitalizations within the year following the beginning of the program

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start27 Jul 2018
  3. Primary completion27 Nov 2019
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03642808
Sponsor's protocol ID
OPTICHUTE
Acronym
OPTICHUTE
Status last verified
Apr 2023
First submitted
8 Aug 2018
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 14600804

  • 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.

    PubMed 22521109

  • 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.

    PubMed 2738307

  • 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.

    PubMed 23296743

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

    PubMed 28426444

  • 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.

    PubMed 1593914

  • 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.

    PubMed 5349366

  • 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.

    PubMed 14044222

  • 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.

    PubMed 24903196

  • 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.

    PubMed 28972994

  • 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.

    PubMed 1202204

Questions about this trial

What is this clinical trial studying?

A study testing rehabilitation program in people with Osteoporotic Fractures, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance and satisfaction of patients with reinforced medical care (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642808, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.

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