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

March 4, 2019 updated by: Amgen

Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 602 00
        • Research Site
      • Brno, Czechia, 638 00
        • Research Site
      • Ceske Budejovice, Czechia, 370 01
        • Research Site
      • Havlickuv Brod, Czechia, 580 22
        • Research Site
      • Karlovy Vary, Czechia, 367 17
        • Research Site
      • Kutna Hora, Czechia, 284 01
        • Research Site
      • Ostrava, Czechia, 702 00
        • Research Site
      • Ostrava-Trebovice, Czechia, 722 00
        • Research Site
      • Plzen, Czechia, 323 00
        • Research Site
      • Praha 11, Czechia, 148 00
        • Research Site
      • Praha 2, Czechia, 128 50
        • Research Site
      • Praha 4 - Nusle, Czechia, 140 00
        • Research Site
      • Trutnov, Czechia, 541 21
        • Research Site
      • Vsetin, Czechia, 755 01
        • Research Site
      • Zlin, Czechia, 760 01
        • Research Site
      • Zlin, Czechia
        • Osteocentrum Zlin
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Bratislava, Slovakia, 826 06
        • Research Site
      • Bratislava, Slovakia, 833 05
        • Research Site
      • Humenne, Slovakia, 066 01
        • Research Site
      • Kosice, Slovakia, 040 01
        • Research Site
      • Kosice-Saca, Slovakia, 040 15
        • Research Site
      • Lubochna, Slovakia, 034 91
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Martin, Slovakia, 036 01
        • Research Site
      • Nitra, Slovakia, 949 01
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
      • Trnava, Slovakia, 917 75
        • Research Site
      • Zilina, Slovakia, 010 01
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study was conducted at various study centers in the Czech Republic and Slovakia. Postmenopausal women with osteoporosis who receive an injection of denosumab and meet the inclusion/exclusion criteria will be eligible to participate in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
Biological: Denosumab
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Other Names:
  • Prolia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Time Frame: 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.
24 months
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Time Frame: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Baseline (day 1), and at 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
Time Frame: 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.
Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Time Frame: 24 months
24 months
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Time Frame: 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.
Baseline (day 1)
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Time Frame: 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.
Month 6
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Time Frame: 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.
Month 12
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Time Frame: 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.
Month 18
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Time Frame: 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.
Month 24
Number of Denosumab Post-baseline Injections Received by Each Participant
Time Frame: 24 months
24 months
Number of Participants Having Radiologic Bone Assessments
Time Frame: 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.
Pre-baseline (before first denosumab injection) and during the study (post-baseline)
Number of Participants Having Osteoporosis Related Laboratory Examinations
Time Frame: 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.
Pre-baseline (before first denosumab injection) and post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Time Frame: 24 months
Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
24 months
Number of Participants With Serious ADRs to Denosumab
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

One Amgen Center Drive
THOUSAND OAKS
CA
91320-1799
USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2012

Primary Completion (Actual)

May 15, 2015

Study Completion (Actual)

May 15, 2015

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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