ITMO public health
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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