FRAG'OS - Estimation via the WHO index (FRAX®) of the risk of fracture by bone fragility in French women 
Head :
VIGNAL Franck, Sanofi Aventis
Last update : 01/01/2018 | Version : 1 | ID : 86
| General | |
| Identification | |
| Detailed name | Estimation via the WHO index (FRAX®) of the risk of fracture by bone fragility in French women |
| Sign or acronym | FRAG'OS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Internal medicine Rheumatology |
| Others (details) | bone fracture, osteoporosis |
| Keywords | internal medicine, FRAX index, fracture risk estimate |
| Scientific investigator(s) (Contact) | |
| Name of the director | VIGNAL |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi-aventis.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | sanofi-aventis |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Estimation via the WHO index (FRAX®) of the risk of fracture by bone fragility in French women aged 50 years and older, with osteoporosis |
| Inclusion criteria |
An antecedent of osteoporotic fracture, i.e. of a fracture occurring after the age of 45 years, without major trauma; A T-score at at least one of the two sites, lumbar or femoral, ≤ -2.5 SD ; Treated or not |
| 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) |
[1000-10 000[ individuals |
| Details of the number of individuals | 4249 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Health parameters studied |
Quality of life/health perception |
| Procedures | |
| Data collection method | internal medicine, osteoporosis, FRAX index, fracture risk estimate |
| 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) | SFR 2009 results poster. methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
