Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Biological: Denosumab

• Registration Number: NCT01652690
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-26
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-30
• Primary Completion: 2015-05-15
• Study Completion: 2015-05-15
• Results First Submitted: 2016-04-20
• Results First Submitted QC: 2016-04-20
• Results First Posted: 2016-05-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab	Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.

Primary Outcome Measures

Name	Time	Method
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection	Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection	Month 24	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection	Month 6	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection	Month 12	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection	Month 18	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
Number of Denosumab Post-baseline Injections Received by Each Participant	24 months
Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office	24 months	Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care	24 months
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection	Baseline (day 1)	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
Number of Participants Having Radiologic Bone Assessments	Pre-baseline (before first denosumab injection) and during the study (post-baseline)	Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
Number of Participants Having Osteoporosis Related Laboratory Examinations	Pre-baseline (before first denosumab injection) and post-baseline	Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.
Number of Participants Receiving All Prescriptions and Injections of Denosumab	Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)	Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab	24 months	Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
Number of Participants With Serious ADRs to Denosumab	24 months	Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.

Trial Locations

Locations (2)

Osteocentrum Zlin; 🇨🇿 Zlin, Czechia

Research Site; 🇸🇰 Zilina, Slovakia