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