Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis

Amgen

Status: Completed

Conditions: Osteoporosis, Age-Related

Study type: Observational

Funder types: Industry

Identifiers

NCT02732210

20101218

Details and patient eligibility

About

The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.

Full description

The study was a multi-center, single-arm, prospective, non-interventional observational study in postmenopausal women with osteoporosis who had been treated with Prolia® for osteoporosis in routine clinical practice.

Enrollment: 935 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Enrollment within 4 weeks following administration of the first Prolia® (denosumab 60 mg) injection
• Received Prolia® subcutaneously for treatment of osteoporosis consistent with local (US/Canada) product label
• Subject or subject's legally acceptable representative has provided informed consent. Exclusion Criteria:
• Participation in ongoing or previous denosumab clinical trials
• Currently enrolled in another investigational device or drug study, or less than 6 months since ending another investigational device or drug study(s), or receiving other investigational agent(s)
• Contra-indicated for treatment with Prolia® according to the approved applicable local product label (US/Canada)
• 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.