Osteoporosis Musculoskeletal Diseases Osteoporosis, unspecified
Conditions
Interventions
Observational study to get information about therapy of osteoporosis with Protelos®
under daily routine practice by orthopedic surgeons and general practitioners.
The treatment decision must be made prior to study initiation. Treating physicians will confirm the diag
Sponsors
Servier Deutschland GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men with osteoporosis at increased risk of fractures 2. Postmenopausal women with osteoporosis at increased risk of fractures
Exclusion criteria
Exclusion criteria: 1. Does not meet inclusion criteria 2. In addition, doctors involved in the trial should follow the Summary of Product Characteristics (SmPC) for Protelos®, which includes the following contraindications: 2.1 Hypersensitivity to the active substance or to any of the excipients. 2.2 Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism. 2.3 Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effects of Protelos® on the osteoporosis-related pain 2. Effects of Protelos® on quality of life assessed by EQ-5D 3. Effects of Protelos® on analgesics prescription 4. Information about how Protelos® SmPC and patient information are followed via standardised documentation 5. Analysis of general tolerability of Protelos® under routine conditions via standardised adverse reactions documentation and standardised documentation of therapy discontinuation 6. Analysis of unknown adverse drug reactions via standardised documentation | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Germany
Outcome results
None listed