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

Not Applicable

Completed

• Conditions: Osteoporosis With Current Fragility Fracture
• Interventions: Behavioral: Osteoporosis prevention program

• Registration Number: NCT01780012
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-05
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 436

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Osteoporosis prevention program	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.

Primary Outcome Measures

Name	Time	Method
Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).	6 months after inclusion	At 6 months, women will be asked whether or not they received a BMD test prescription and/or an osteoporosis treatment prescription by their physician.

Secondary Outcome Measures

Name	Time	Method
Proportion of women in the two groups who changed their behaviour in order to prevent future fractures: regular practice of physical activity, dairy products consumption and calcium and vitamin D supplementation.	6 months after inclusion.	Women will answer the same questionnaire at inclusion and at 6 months to assess their behaviour towards fracture risk or prevention of osteoporosis: physical activity, dairy products consumption and calcium and vitamin D supplementation
Proportion of women in the two groups who performed BMD at 6 months	6 months after inclusion	At 6 months, women who received a BMD prescription will be asked whether or not they performed a BMD test; if they realized a BMD test, their result will be asked.
Proportion of women in the two groups with an increased perception of fracture risk.	6 months after inclusion	Women will answer the same questionnaire at inclusion and at 6 months to assess their fracture risk perception.
Proportion of women who improved their knowledge about osteoporosis	6 months after inclusion	Women will answer the same questionnaire at inclusion and at 6 months to assess their osteoporosis perception and knowledge (risk factors, severity,consequences, treatments)

Trial Locations

Locations (1)

Pôle IMER, Hospices Civils de Lyon; 🇫🇷 LYON cedex 03, France