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

Primary Purpose

Osteoporosis With Current Fragility Fracture

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteoporosis prevention program
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis With Current Fragility Fracture focused on measuring osteoporosis, fragility fracture, secondary prevention

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pôle IMER, Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Control women will receive usual post-fracture care without information

Outcomes

Primary Outcome Measures

Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).
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
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.
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.
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
Women will answer the same questionnaire at inclusion and at 6 months to assess their osteoporosis perception and knowledge (risk factors, severity,consequences, treatments)

Full Information

First Posted
January 28, 2013
Last Updated
August 2, 2017
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01780012
Brief Title
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb
Acronym
PREVOST
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis With Current Fragility Fracture
Keywords
osteoporosis, fragility fracture, secondary prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control women will receive usual post-fracture care without information
Intervention Type
Behavioral
Intervention Name(s)
Osteoporosis prevention program
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).
Description
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
Secondary Outcome Measure Information:
Title
Proportion of women in the two groups who performed BMD at 6 months
Description
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
Title
Proportion of women in the two groups with an increased perception of fracture risk.
Description
Women will answer the same questionnaire at inclusion and at 6 months to assess their fracture risk perception.
Time Frame
6 months after inclusion
Title
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.
Description
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.
Title
Proportion of women who improved their knowledge about osteoporosis
Description
Women will answer the same questionnaire at inclusion and at 6 months to assess their osteoporosis perception and knowledge (risk factors, severity,consequences, treatments)
Time Frame
6 months after inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Pôle IMER, Hospices Civils de Lyon
City
LYON cedex 03
ZIP/Postal Code
69424
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28246884
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.
Results Reference
derived

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

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