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

December 13, 2025 updated by: Hospices Civils de Lyon

Secondary Prevention of Osteoporosis in Women Over 50 Years Old After Low Intensity Fracture of the Upper Limb: Evaluation of an Intervention Focused on the Patient.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69424
        • Pôle IMER, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Behavioral: Osteoporosis prevention program
Women will receive an oral information and advices on osteoporosis, a written leaflet on osteoporosis (risk factors, diagnosis, prevention and treatments), a letter and a leaflet on osteoporosis management to give to their family physician and phone call reminders (D15, D30, D45) to advise them to consult their family physician and, if they have a BMD prescription, to perform their BMD
No Intervention: Control
Control women will receive usual post-fracture care without information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).
Time Frame: 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.
6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women in the two groups who performed BMD at 6 months
Time Frame: 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.
6 months after inclusion
Proportion of women in the two groups with an increased perception of fracture risk.
Time Frame: 6 months after inclusion
Women will answer the same questionnaire at inclusion and at 6 months to assess their fracture risk perception.
6 months after inclusion
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.
Time Frame: 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
6 months after inclusion.
Proportion of women who improved their knowledge about osteoporosis
Time Frame: 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)
6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimated)

January 30, 2013

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVOST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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