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

Osteoporosis With Current Fragility Fracture Clinical Trial

— PREVOST  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780012
• Other study ID #: PREVOST
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: August 2, 2017
• Start date: March 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporosis With Current Fragility Fracture
• Osteoporotic Fractures

Intervention

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

Locations

Country	Name	City	State
France	Pôle IMER, Hospices Civils de Lyon	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of women in the two groups who performed BMD at 6 months	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
Secondary	Proportion of women in the two groups with an increased perception of fracture risk.	Women will answer the same questionnaire at inclusion and at 6 months to assess their fracture risk perception.	6 months after inclusion
Secondary	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.	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.
Secondary	Proportion of women who improved their knowledge about osteoporosis	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