Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
NCT ID: NCT01652690
Last Updated: 2019-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
600 participants
OBSERVATIONAL
2012-06-26
2015-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
Denosumab
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Interventions
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Denosumab
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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One Amgen Center Drive
UNKNOWN
THOUSAND OAKS
UNKNOWN
CA
UNKNOWN
91320-1799
UNKNOWN
USA
UNKNOWN
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
České Budějovice, , Czechia
Research Site
Havlíčkův Brod, , Czechia
Research Site
Karlovy Vary, , Czechia
Research Site
Kutná Hora, , Czechia
Research Site
Ostrava, , Czechia
Research Site
Ostrava-Trebovice, , Czechia
Research Site
Pilsen, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Praha 4 - Nusle, , Czechia
Research Site
Trutnov, , Czechia
Research Site
Vsetín, , Czechia
Research Site
Zlín, , Czechia
Osteocentrum Zlin
Zlín, , Czechia
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Humenné, , Slovakia
Research Site
Kosice-Saca, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Lučenec, , Slovakia
Research Site
Ľubochňa, , Slovakia
Research Site
Martin, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Trnava, , Slovakia
Research Site
Žilina, , Slovakia
Countries
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References
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Ruzickova O, Killinger Z, Kasalicky P, Hamilton L, Tyl R, Tomkova S, Kalouche-Khalil L. Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia. Adv Ther. 2018 Oct;35(10):1713-1728. doi: 10.1007/s12325-018-0779-9. Epub 2018 Sep 6.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110132
Identifier Type: -
Identifier Source: org_study_id
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