Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

Amgen

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Biological: Denosumab

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01652690

20110132

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Women with a clinical diagnosis of postmenopausal osteoporosis
• Decision has been made to treat with denosumab 60 mg once every 6 months
• Have received their first injection of denosumab within 8 weeks prior to enrolling in this study.
• Appropriate written informed consent has been obtained (as required per local country regulations)

Exclusion Criteria

• Participating in ongoing or have participated in previous denosumab clinical trials
• Participation in other clinical or device trials in the last 6 months
• Contra-indicated for treatment with Prolia® according to the approved applicable local product label.
• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent

Trial design

600 participants in 1 patient group

Denosumab

Description:

Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.

Treatment:

Biological: Denosumab