Clinical trial NCT01780012: Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis With Current Fragility Fracture
Keywords: osteoporosis
fragility fracture
secondary prevention
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 436
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Proportion of women in the two groups who performed BMD at 6 months
timeFrame: 6 months after inclusion
measure: Proportion of women in the two groups with an increased perception of fracture risk.
timeFrame: 6 months after inclusion
measure: 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.
timeFrame: 6 months after inclusion.
measure: Proportion of women who improved their knowledge about osteoporosis
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Pôle IMER, Hospices Civils de Lyon
Study officials:
References:
citation: 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.