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Osteoporosis Awareness Survey of Women in Champagne Ardenne (MPCosteoporose)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537846
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief Summary:

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.


Condition or disease
Osteoporosis

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 Design
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Study Type : Observational
Actual Enrollment : 274 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Osteoporosis Awareness Survey of Women in Champagne Ardenne
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Groups and Cohorts
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Group/Cohort
Osteoporosis and women
Patient women over thirty years old


Outcome Measures
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Primary Outcome Measures :
  1. Descriptive analysis with sorting flat and crossed sorting and calculation percentage [ Time Frame: Day 0 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   gender identity
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women
Criteria

inclusion criteria :

  • gender : women
  • age over thirty years old

exclusion criteria :

  • Cognitive state incompatible with the collection of information
  • women doctors
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537846


Locations
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France
Chu Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03537846    
Other Study ID Numbers: PO18048
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases