PRESAGE - Observationnal study on Postmenopausal woman 
Head :
Hébuterne Xavier, Eli Lilly France
Last update : 01/01/2018 | Version : 1 | ID : 68
| General | |
| Identification | |
| Detailed name | Observationnal study on Postmenopausal woman |
| Sign or acronym | PRESAGE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°907026 |
| General Aspects | |
| Medical area |
Rheumatology |
| Others (details) | osteoporosis |
| Keywords | Postmenopausal women, mineral bone density, osteoporosis |
| Scientific investigator(s) (Contact) | |
| Name of the director | Hébuterne |
| Surname | Xavier |
| PHARMACOEPI_FRMAIL@LILLY.COM | |
| Unit | Eli Lilly France |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Eli Lilly and Company |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Eli Lilly |
| 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. | Recruitment of patients in private-practicing or hospital BMD centers directed by rheumatologists in the normal practice of care. |
| Database objective | |
| Main objective |
Primary objective: estimate the percentage of osteoporotic patients among postmenopausal patients with a mineral bone density measurement for diagnosis purposes and who can benefit from therapeutic recommendations according to French recommendations. Secondary objectives: factors associated with osteoporosis, characteristics and care for patients |
| Inclusion criteria |
Postmenopausal woman, - Patient not treated for osteoporosis for at least one year (HRT, raloxifene, bisphosphonate, teriparatide, strontium ranelate), - Patient coming for a bone densitometry for diagnosis purposes, - Patient able to benefit from a therapeutic recommendation for the treatment of osteoporosis (osteopenic or osteoporotic patient with risk factors of fractures). |
| 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 | National |
| 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) |
[500-1000[ individuals |
| Details of the number of individuals | 646 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Paraclinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Paraclinical data (detail) | Bone densitometry |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Data collection notebook |
| 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) | Report, poster and publication |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
