Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)

Civil Hospices of Lyon

Status: Completed

Conditions: Osteoporosis With Current Fragility Fracture

Treatments: Behavioral: Osteoporosis prevention program

Study type: Interventional

Funder types: Other

Identifiers

NCT01780012

PREVOST

Details and patient eligibility

About

Osteoporosis is a disease characterized by reduced bone mass and increased skeletal fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture is a powerful predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007). Osteoporotic fractures are associated with an increased morbidity and mortality but also high financial costs. However, less than 20% of patients presenting a low trauma fracture receive an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The hypothesis of a lack of information and an under assessment of consequences by both patients and physicians has been raised to explain this gap between recommended care and usual practices.

The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.

This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.

Enrollment: 436 patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged over 50 years
• with a fragility fracture of wrist or humerus that occurred in the past 6 months
• treated in an emergency department or orthopedic department
• who signed the consent form

Exclusion criteria

• no signed consent
• previous history of femoral neck fracture
• poly-trauma or accident
• patients under osteoporosis treatment
• patients who performed a BMD test in the past 6 months
• patients with severe renal impairment, hyperthyroidism, bone primary or secondary malignancy.
• legal disability
• difficulty in understanding French
• psychiatric disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

Intervention

Experimental group

Description:

Osteoporosis prevention program: Women will receive oral and written information and advices on osteoporosis, a letter and a leaflet on osteoporosis management to give to their family physician, and phone call reminders.

Treatment:

Behavioral: Osteoporosis prevention program

Control

No Intervention group

Description:

Control women will receive usual post-fracture care without information