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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Postmenopausal

Intervention: Prolia (Drug)

Phase: N/A

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with Prolia® (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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Incidence (yes/no) of patients receiving all prescriptions and injections of Prolia® from the initial prescribing physician's office

Incidence (yes/no) of patients receiving an individual prescription and injection of Prolia® from the initial prescribing physician office by each individual injection

Incidence (yes/no) of patients receiving all prescriptions and injections of Prolia®, whether or not the injections are given at the initial prescribing physician's office

Incidence (yes/no) of patients with a referral by the prescribing physician to other health care providers for continuation or follow up of care by type of physician

Types of health care providers administering an individual injection of Prolia® inside or outside the initial prescribing office by injection

Number of Prolia® injections received by each patient during the follow-up period

Incidence (yes/no) of patients having radiologic bone assessments pre-treatment with Prolia®, and during the study

Incidence (yes/no) of patients having osteoporosis related laboratory examinations pre-treatment with Prolia®, and during the study.

Secondary outcome:

Incidence (yes/no) of patients with ADR to Prolia®.

Incidence (yes/no) of patients with serious ADR to Prolia®.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria Women with a clinical diagnosis of postmenopausal osteoporosis Decision has been made to treat with Prolia® 60 mg once every 6 months Have received their first injection of Prolia® 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

Locations and Contacts

Research Site, Brno 602 00, Czech Republic

Research Site, Brno 638 00, Czech Republic

Research Site, Ceske Budejovice 370 01, Czech Republic

Research Site, Havlickuv Brod 580 22, Czech Republic

Research Site, Karlovy Vary 367 17, Czech Republic

Research Site, Kutna Hora 284 01, Czech Republic

Research Site, Ostrava-Trebovice 722 00, Czech Republic

Research Site, Ostrava 702 00, Czech Republic

Research Site, Plzen 323 00, Czech Republic

Research Site, Praha 11 148 00, Czech Republic

Research Site, Praha 2 128 50, Czech Republic

Research Site, Praha 4 - Nusle 140 00, Czech Republic

Research Site, Trutnov 541 21, Czech Republic

Research Site, Vsetin 755 01, Czech Republic

Osteocentrum Zlin, Zlin, Czech Republic

Research Site, Zlin 760 01, Czech Republic

Research Site, Banska Bystrica 974 01, Slovakia

Research Site, Bratislava 826 06, Slovakia

Research Site, Bratislava 833 05, Slovakia

Research Site, Humenne 066 01, Slovakia

Research Site, Kosice-Saca 040 15, Slovakia

Research Site, Kosice 040 01, Slovakia

Research Site, Lubochna 034 91, Slovakia

Research Site, Lucenec 984 01, Slovakia

Research Site, Martin 036 01, Slovakia

Research Site, Nitra 949 01, Slovakia

Research Site, Presov 080 01, Slovakia

Research Site, Trnava 917 75, Slovakia

Research Site, Zilina 010 01, Slovakia

Additional Information

AmgenTrials clinical trials website

Starting date: June 2012
Last updated: July 24, 2015

Page last updated: August 23, 2015

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