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

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2013 by Institut National de la Santé Et de la Recherche Médicale, France

Sponsor:

Information provided by (Responsible Party):

Institut National de la Santé Et de la Recherche Médicale, France

ClinicalTrials.gov Identifier:

NCT01780012

First received: January 28, 2013

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Purpose

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 powerfull predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (Center JR, 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 recommanded 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	Intervention
Osteoporosis With Current Fragility Fracture	Behavioral: Osteoporosis prevention program


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

Proportion of women in the two groups who performed BMD at 6 months [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: No ]
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.
Proportion of women in the two groups with an increased perception of fracture risk. [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: No ]
Women will answer the same questionnaire at inclusion and at 6 months to assess their fracture risk perception.
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. ] [ Designated as safety issue: No ]
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
Proportion of women who improved their knowledge about osteoporosis [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: No ]
Women will answer the same questionnaire at inclusion and at 6 months to assess their osteoporosis perception and knowledge (risk factors, severity,consequences, treatments)


Estimated Enrollment:	446
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility


Ages Eligible for Study:	50 Years to 85 Years
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780012

Contacts


Contact: Anne-Marie SCHOTT, Professor	00 33 4 72115371	anne-marie.schott-pethelaz@chu-lyon.fr
Contact: Roland CHAPURLAT, Professor	00 33 4 72116759	roland.chapurlat@inserm.fr

Locations


France
Pôle IMER, Hospices Civils de Lyon	Recruiting
LYON cedex 03, France, 69424
Principal Investigator: Anne-Marie SCHOTT, Professor

Sponsors and Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

More Information

No publications provided


Responsible Party:	Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:	NCT01780012 History of Changes
Other Study ID Numbers:	PREVOST
Study First Received:	January 28, 2013
Last Updated:	January 29, 2013
Health Authority:	France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: The Commission nationale de l’informatique et des libertés

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:


osteoporosis fragility fracture secondary prevention

Additional relevant MeSH terms:


Osteoporosis Bone Diseases Bone Diseases, Metabolic Musculoskeletal Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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