POSTEPI - Management of osteoporosis and associated quality of life in post menopausal women 
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 01/01/2018 | Version : 1 | ID : 159
| 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 |
| 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 |
