Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
Status: | Completed |
---|---|
Conditions: | Osteoporosis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/22/2019 |
Start Date: | July 6, 2011 |
End Date: | April 14, 2014 |
Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice
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.
subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.
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.
in postmenopausal women with osteoporosis who had been treated with Prolia® for osteoporosis
in routine clinical practice.
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.
We found this trial at
61
sites
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