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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Osteoporosis With Current Fragility Fracture	Behavioral: Osteoporosis prevention program	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	436 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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.
Study Start Date :	March 2012
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	August 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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
4. 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)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Pôle IMER, Hospices Civils de Lyon
LYON cedex 03, France, 69424

Sponsors and Collaborators

Hospices Civils de Lyon

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT01780012 History of Changes
Other Study ID Numbers:	PREVOST
First Posted:	January 30, 2013
Last Update Posted:	August 3, 2017
Last Verified:	May 2016

Keywords provided by Hospices Civils de Lyon:

osteoporosis; fragility fracture; secondary prevention

Additional relevant MeSH terms:

Fractures, Bone; Osteoporosis; Osteoporotic Fractures; Wounds and Injuries	Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases