N/A
N=1,501
Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01668589 ↗Enrolled (actual)
1,501
Serious AEs
0.2%
Results posted
Sep 2016
Primary outcome: Primary: Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months — 92.2; 89.3; 94.3; 95.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months |
92.2; 89.3; 94.3; 95.7; 75.1; 79.7 | — |
| PRIMARY Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months |
87.6; 85.0; 89.6; 89.0; 62.9; 66.0 | — |
| PRIMARY Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months |
94.5; 93.2; 95.8; 96.2; 87.4; 87.9 | — |
| SECONDARY Time to Non-persistence With Denosumab Injection |
12.23; 6.03; 12.00; 12.20 | — |
| SECONDARY Percentage of Participants Who Received Denosumab Injections Within the Specified Window |
5.9; 9.7; 2.7; 3.7; 7.8; 3.7 | — |
| SECONDARY Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months |
4.4; 4.1; 6.6; 4.1 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months |
3.4; 3.7; 6.0; 3.1 | — |
| SECONDARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months |
6.5; 8.2; 8.4; 7.8 | — |
Summary
The main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.
Eligibility Criteria
Inclusion Criteria
- Indicated for treatment of osteoporosis in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
- Enrolled into the study within 4 weeks of receiving their first injection of Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
- Appropriate written informed consent has been obtained (as required per local country regulations).
Exclusion Criteria
- Patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug.
- Contraindicated for treatment with Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
- Participation in ongoing or previous denosumab clinical trials.
- Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent.
Data sourced from ClinicalTrials.gov (NCT01668589). 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.