Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03642808
Other study ID # OPTICHUTE
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 27, 2018
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 17
Est. completion date December 31, 2023
Est. primary completion date November 27, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (2)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph Hôpital Sainte-Marie Paris

Country where clinical trial is conducted

France, 

References & Publications (11)

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 — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 availabl — View Citation

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. — View Citation

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 2 — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Number of news falls Number of new falls within the year following the beginning of the program 1 year
Secondary Number of new osteoporotic fractures Number of new osteoporotic fractures within the year following the beginning of the program 1 year
Secondary Number of new hospitalizations Number of new hospitalizations within the year following the beginning of the program 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06367582 - SPINE BONE CEMENTS OUTCOMES
Completed NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Not yet recruiting NCT05738785 - Risk of Osteoporotic Fracture in Home Care Patients in Turkey
Recruiting NCT05489952 - Iron Supplementation for Geriatric Hip Fractures Phase 4
Not yet recruiting NCT06455085 - RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE N/A
Enrolling by invitation NCT05018637 - Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture Phase 2
Completed NCT02972424 - PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial Phase 2
Recruiting NCT02247011 - A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women N/A
Completed NCT04911946 - Training of Orthopedic Residents in OP Treatment
Completed NCT02753283 - Preventing Osteoporosis Using Denosumab Phase 4
Recruiting NCT02148848 - Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty Phase 4
Terminated NCT01532076 - Effectiveness of Adipose Tissue Derived Mesenchymal Stem Cells as Osteogenic Component in Composite Grafts Phase 2
Completed NCT00594295 - Follow-up of Bone Quality in Long-Term Bone Marrow Transplant Survivors N/A
Not yet recruiting NCT05866029 - Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture N/A
Enrolling by invitation NCT03994094 - Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures
Recruiting NCT05388227 - Pole Walking Intervention in Retirement Communities
Recruiting NCT05424536 - Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical Measurement
Not yet recruiting NCT05943600 - An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective
Recruiting NCT05848167 - Senile Osteoporotic Fractures Cohort Study(SOFCS)