- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537846
Osteoporosis Awareness Survey of Women in Champagne Ardenne (MPCosteoporose)
Osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. In the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. It is therefore important to sensitize women to this pathology at the beginning of menopause.
Osteoporosis is a public health issue with more than 3 million women in France suffering from almost ¼ of the population over 50 years old. Paradoxically, the number of bone densitometry and prescribed osteoporosis drugs are decreasing. There is an under-screening and a disinterest of the pathology on the part of the medical world and the patients.
The investigators hypothesize that women lack knowledge about osteoporosis. This study will identify these gaps, and put in place appropriate strategies to improve this knowledge.
For this purpose, a descriptive cross-sectional observational study will carry out, through the fulfillment of self-administered questionnaire for women over 30 years old. The main objective is to assess the knowledge of women, about osteoporosis and its consequences. The judgment criterion is based on a percentage of correct answers per question. The interests of the study are to identify gaps in knowledge, to optimize the investigator's therapeutic education, to fight patient wait-and-see and false beliefs, and finally to improve adherence and longer-term adherence.
Study Overview
Status
Conditions
Detailed Description
This is a descriptive cross-sectional observational study, recruiting women over 30 years old, by the diffusion of the questionnaire in the general practices of Champagne-Ardenne, and the rheumatology department of CHU de Reims.
The main objective of the study is to assess the knowledge of women over 30 on osteoporosis and its consequences. The judgment criterion is a calculation of the percentage of correct answers per question. The investigation plan is based on a self-administered questionnaire survey .The statistical analysis plan is based on a descriptive analysis with sorting flat and sorted; The questionnaires will be disseminated from March 2018 to May 2018, with the valuation of results on June 1, 2018.
This questionnaire includes:
- 6 questions relating to the patient : risk of osteoporosis and specific management.
- 17 questions about osteoporosis knowledge
- 8 questions about information resources received on osteoporosis ( media, general practitioner …) The questionnaire will be accompanied by a cover letter and a consent form. The filling of the questionnaire should last between 5 and 7 minutes. The patient will then give back the questionnaire directly to the person who has offered him to fill it out (general practitioner, rheumatologist, nurse).
The questionnaires will be placed in waiting rooms of doctors, dentists, and paramedics of the Marne, the Ardennes, and the Aube.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Reims, France, 51092
- CHU Reims
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
inclusion criteria :
- gender : women
- age over thirty years old
exclusion criteria :
- Cognitive state incompatible with the collection of information
- women doctors
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Osteoporosis and women
Patient women over thirty years old
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Descriptive analysis with sorting flat and crossed sorting and calculation percentage
Time Frame: Day 0
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Day 0
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO18048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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