Trials / Completed
CompletedNCT01652690
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Denosumab | This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study. |
Timeline
- Start date
- 2012-06-26
- Primary completion
- 2015-05-15
- Completion
- 2015-05-15
- First posted
- 2012-07-30
- Last updated
- 2019-03-06
- Results posted
- 2016-05-26
Locations
29 sites across 2 countries: Czechia, Slovakia
Source: ClinicalTrials.gov record NCT01652690. Inclusion in this directory is not an endorsement.