Pôle IMER, Hospices Civils de Lyon
Lyon, 69424, France
NCT Number: NCT01780012
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.
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Notify Me50 year–85 year
Female
Interventional
Not applicable
Lyon, 69424, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Time frame: 6 months after inclusion
Women will answer the same questionnaire at inclusion and at 6 months to assess their fracture risk perception.
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
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)
Hospices Civils de Lyon
Other
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.
Acronym: PREVOST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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