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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03537846
Other study ID # PO18048
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2018
Est. completion date April 30, 2018

Study information

Verified date July 2018
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years and older
Eligibility inclusion criteria :

- gender : women

- age over thirty years old

exclusion criteria :

- Cognitive state incompatible with the collection of information

- women doctors

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chu Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Descriptive analysis with sorting flat and crossed sorting and calculation percentage Day 0
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