N/A
Completed N=600
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
Osteoporosis, Postmenopausal
Source: ClinicalTrials.gov NCT01652690 ↗
Enrolled (actual)
600
Serious AEs
0.2%
Results posted
May 2016
Primary outcomePrimary: Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office — 295; 296 participants
Summary
The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office |
295; 296 | — |
| PRIMARY Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection |
300; 298; 282; 291; 275; 282 | — |
| PRIMARY Number of Participants Receiving All Prescriptions and Injections of Denosumab |
283; 293; 276; 283; 262; 276 | — |
| PRIMARY Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care |
0; 2; 0; 2 | — |
| PRIMARY Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection |
54; 84; 19; 21; 227; 195 | — |
| PRIMARY Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection |
70; 109; 8; 0; 205; 184 | — |
| PRIMARY Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection |
75; 104; 0; 0; 201; 179 | — |
| PRIMARY Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection |
69; 113; 4; 1; 189; 162 | — |
| PRIMARY Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection |
76; 93; 0; 6; 170; 144 | — |
| PRIMARY Number of Denosumab Post-baseline Injections Received by Each Participant |
17; 7; 7; 10; 14; 7 | — |
| PRIMARY Number of Participants Having Radiologic Bone Assessments |
297; 299; 253; 216 | — |
| PRIMARY Number of Participants Having Osteoporosis Related Laboratory Examinations |
230; 260; 148; 207; 162; 224 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab |
4; 12; 2; 5; 0; 0 | — |
| SECONDARY Number of Participants With Serious ADRs to Denosumab |
0; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Women with a clinical diagnosis of postmenopausal osteoporosis
- Decision has been made to treat with denosumab 60 mg once every 6 months
- Have received their first injection of denosumab within 8 weeks prior to enrolling in this study.
- Appropriate written informed consent has been obtained (as required per local country regulations)
Exclusion Criteria
- Participating in ongoing or have participated in previous denosumab clinical trials
- Participation in other clinical or device trials in the last 6 months
- Contra-indicated for treatment with Prolia® according to the approved applicable local product label.
- 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 (NCT01652690). 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.