POSTEPI - Management of osteoporosis and associated quality of life in post menopausal women ARCHIVE

Head :
Leclerc-Zwirn Christel, Laboratoire GSK

Last update : 01/01/2018 | Version : 1 | ID : 159

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Management of osteoporosis and associated quality of life in post menopausal women
Sign or acronym POSTEPI
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation --
General Aspects
Medical area General practice
Rheumatology
Health determinants Iatrogenic
Others (details) Osteoporosis
Keywords observation, fracture, observance
Scientific investigator(s) (Contact)
Name of the director Leclerc-Zwirn
Surname Christel
Phone +33 (0)1 39 17 86 96
Email christel.C.leclerc-zwirn@gsk.com
Unit Laboratoire GSK
Collaborations
Funding
Funding status Private
Details GSK laboratory
Governance of the database
Sponsor(s) or organisation(s) responsible LABORATOIRE GSK
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Not-repeated cross-sectional studies (except case control studies)
Database recruitment is carried out by an intermediary A selection of health care professionals
A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. The list of general practitioners, rheumatologists and gynecologists who can participate in the study was established via a random drawing stratified by regions in order to ensure national representativeness of the doctors. A selection process in several waves was set up in order to obtain the required number of doctors. Throughout the entire study, the doctor completed, for all of the patients seen in consultation and having the criteria for participating in the registry, a medical questionnaire
Database objective
Main objective In the framework of the new screening and reimbursement conditions for osteoporosis medications, describe the profile of postmenopausal women with osteoporosis and treated for less than 6 months
Inclusion criteria Postmenopausal women diagnosed with osteoporosis less than 6 months ago via low BMD (Femoral total T score and/or spinal average <-2.5) or on a fracture not linked to a major trauma or to a cancer and treated for less than 6 months
Population type
Age Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2007
Date of last collection (YYYY or MM/YYYY) 2008
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 1306
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Presence of a biobank No
Health parameters studied Quality of life/health perception
Others
Other (detail) observance (MMAS)
Procedures
Data collection method Registry, medical questionnaire and patient self-questionnaire
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Publications: Cortet et al. Musculoskeletal Disorder. 2011 / Huas et al. Women's Health. 2010
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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