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Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060747
Acronym
OPTIPOST
Enrollment
480
Registered
2014-02-12
Start date
2013-07-01
Completion date
2016-12-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Management Care, Fracture

Brief summary

Harrington's metaphorical depiction captures the essence of the problem : Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears. The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as Fracture Liaison Service (United-Kingdom \[1-3\], Europe \[4,5\] and Australia \[6-8\]) Osteoporosis Coordinator Program (Canada \[9,10\]) or Care Manager Programs (USA \[11,12\]). The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures. Men and women are included aged over 45 years with fragility wrist and hip fractures. Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls. Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months

Interventions

BEHAVIORALCoordinator-based post fracture program

Sponsors

Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* Men and women over 45 years * Fragility wrist and hip fractures * Volunteer

Exclusion criteria

* Public route accident * Emergency illness associated * Short life expectancy * Not volunteer * Bedridden patient

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patient with a correct management care.6 monthsThis outcome is a composite outcome wich differ with each fracture type. It will be assess 6 months after patient inclusion. An adequate management care is defined for each fracture as below. * For wrist fracture: medical visit at J15, osteodensitometry, therapeutic decision if necessary (if not, reasons have to be precised in medical sheet). * For hip fracture: osteodensitometry if necessary, therapeutic (chronic care) decision if necessary (if not, reasons have to be precised in medical sheet).

Secondary

MeasureTime frame
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).6 months

Other

MeasureTime frame
Number of rehospitalisation for fracture.6 months
Number of falls over 6 months post-inclusion.6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026