ADEOS - Adherence evaluation of osteoporosis treatment ARCHIVE

Head :
Leclerc-Zwirn Christel, Laboratoire GSK

Last update : 01/01/2018 | Version : 1 | ID : 151

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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 Adherence evaluation of osteoporosis treatment
Sign or acronym ADEOS
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 770334
General Aspects
Medical area Rheumatology
Others (details) Osteoporosis
Keywords adhesion, tool, osteoporosis, observance, persistence
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
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. The source population (potentially eligible patients) is represented by the patients wherein a treatment for osteoporosis from among those defined in the inclusion criteria is prescribed during a spontaneous consultation of a general practitioner who has accepted to participate in the study. Participating doctors will systematically and consecutively include up to 3 patients who meet all of the eligibility criteria.
Database objective
Main objective Finalize and validate a self-administered instrument developed to evaluate adhesion to the treatment
of postmenopausal osteoporosis
Inclusion criteria Woman;
Over the age of 50 years;
Patient to whom has been prescribed one of the following osteoporosis treatments in the six months prior to the inclusion starting date:
bisphosphonates, selective estrogen receptor modulators (SERM), or strontium ranelate;
Patient fluent in French and who has the cognitive and functional ability required to complete
the self-questionnaires included in the study on their own;
Informed patient who has given their oral consent to participate in this study
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) 2008
Date of last collection (YYYY or MM/YYYY) 2008
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 350
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 Others
Other (detail) adherence, compliance, persistence
Procedures
Data collection method Two types of data will be collected during the study. Data concerning the subjective considerations of the patients will be collected via self-questionnaires. Medical data will be collected through computerized medical collection (""questions on the screen"") completed by the doctor.
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: Breuil et al. Osteoporosis International. 2011
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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