EXFOS - A European prospective observational study to evaluate fracture outcomes, back pain, health-related quality of life, and compliance in patients with osteoporosis during and after treatment with Forsteo®
Head :
Médecin pharmacoépidémiologiste , Eli Lilly France
Last update : 07/22/2015 | Version : 2 | ID : 79
| General | |
| Identification | |
| Detailed name | A European prospective observational study to evaluate fracture outcomes, back pain, health-related quality of life, and compliance in patients with osteoporosis during and after treatment with Forsteo® |
| Sign or acronym | EXFOS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°910339 |
| General Aspects | |
| Medical area |
Rheumatology |
| Keywords | Osteoporotic patients, teriparatide, duration of treatment, conditions of use |
| Scientific investigator(s) (Contact) | |
| Name of the director | Médecin pharmacoépidémiologiste |
| Fr_mail_pharmacoepi@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) |
Longitudinal study (except cohorts) |
| 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. | France: recruitment by rheumatologists in the course of routine care. Random selection of rheumatologists using professional listing. |
| Database objective | |
| Main objective |
Primary objective: determine the incidence of clinical vertebral fractures and non-vertebral fragility fractures in patients treated with teriparatide for about 18 months and a post-treatment follow-up period of at least 18 months.
Secondary objectives: observance, treatment switching and cessation, clinical evolution, occurrence of back pain, direct costs linked to fractures. |
| Inclusion criteria | Osteoporotic patients initiating treatment with teriparatide according to the practitioner's opinion in routine care |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | Croatia, Denmark, France, Greece, Italy, Norway, Slovenia and Sweden |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 1607 |
| 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 |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | Study data collection form |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 36 months maximum |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-EXFOS |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Report and publication |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
