Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis

Amgen

Status: Completed

Conditions: Postmenopausal Osteoporosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01668589

20110126

Details and patient eligibility

About

The main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.

Full description

The decision to treat patients with denosumab was made independent of and before their enrolment in the study. No study drug was administered as part of the study.

Enrollment: 1,501 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indicated for treatment of osteoporosis in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
• Enrolled into the study within 4 weeks of receiving their first injection of Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
• Appropriate written informed consent has been obtained (as required per local country regulations).

Exclusion criteria

• Patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug.
• Contraindicated for treatment with Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
• Participation in ongoing or previous denosumab clinical trials.
• Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent.