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

NCT01780012 | Completed

• 1 other identifier: PREVOST
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis With Current Fragility Fracture

Keywords

osteoporosis; fragility fracture; secondary prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).

  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 Outcomes (4)

• Proportion of women in the two groups who performed BMD at 6 months

  6 months after inclusion

• Proportion of women in the two groups with an increased perception of fracture risk.

  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.

  6 months after inclusion.

• Proportion of women who improved their knowledge about osteoporosis

  6 months after inclusion

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Control women will receive usual post-fracture care without information

Interventions

Osteoporosis prevention program BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pôle IMER, Hospices Civils de Lyon

Lyon, 69424, France

Location

Related Publications (1)

• Merle B, Chapurlat R, Vignot E, Thomas T, Haesebaert J, Schott AM. Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial. Osteoporos Int. 2017 May;28(5):1549-1558. doi: 10.1007/s00198-017-3953-z. Epub 2017 Feb 28.

  PMID: 28246884 RESULT

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)