Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 935
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Persistence With Prolia® at 24 Months
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Percentage of Participants With Persistence With Prolia® at 24 Months
Time Frame: 24 months
A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).
Percentage of Participants With Persistence With Prolia® at 12 Ponths
Time Frame: 12 months
A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.
Secondary Outcomes
- Percentage of Participants Satisfying Medication-taking Behavior at 24 Months(24 months)
- Percentage of Participants Satisfying Medication-taking Behavior at 12 Months(12 months)
- Time to Non-persistence(24 months)
- Number of Prolia® Injections Received(24 months)