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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice

Conditions
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Osteoporosis, Age-Related

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Persistence With Prolia® at 12 Ponths | 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. | 12 months | 
| Percentage of Participants With Persistence With Prolia® at 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). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Non-persistence | For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days). | 24 months | 
| Number of Prolia® Injections Received | The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received. | 24 months | 
| Percentage of Participants Satisfying Medication-taking Behavior at 12 Months | Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks. | 12 months | 
| Percentage of Participants Satisfying Medication-taking Behavior at 24 Months | Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks. | 24 months |