Trial record 7 of 8 for:
Open Studies | "Osteoporotic Fractures"
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)
This study is currently recruiting participants.
Verified January 2013 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
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
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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:
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
|
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
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:
|
Fractures, Bone Osteoporosis Osteoporotic Fractures Wounds and Injuries |
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013