N/A
Completed N=935
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
Osteoporosis, Age-Related
Source: ClinicalTrials.gov NCT02732210 ↗
Enrolled (actual)
935
Serious AEs
13.1%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants With Persistence With Prolia® at 12 Ponths — 87.8; 81.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Persistence With Prolia® at 12 Ponths |
87.8; 81.0 | — |
| PRIMARY Percentage of Participants With Persistence With Prolia® at 24 Months |
74.9; 50.0 | — |
| SECONDARY Time to Non-persistence |
10.69; 12.14 | — |
| SECONDARY Number of Prolia® Injections Received |
5.0; 4.0 | — |
| SECONDARY Percentage of Participants Satisfying Medication-taking Behavior at 12 Months |
82.2; 72.0 | — |
| SECONDARY Percentage of Participants Satisfying Medication-taking Behavior at 24 Months |
62.7; 36.4 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02732210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.