CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 600 enrolled
Drug / intervention
Denosumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01652690
NCT01652690N/ACompleted
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Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

Amgen·observational·Posted Jul 30, 2012·Updated Mar 6, 2019

In Brief

An observational study evaluating Denosumab for Osteoporosis, Postmenopausal. Completed, enrolled 600 participants across 29 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal
CountriesCzechia, Slovakia
CollaboratorsOne Amgen Center Drive, THOUSAND OAKS, CA, 91320-1799, USA

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2012
Enrollment StartJun 26, 2012
Primary CompletionMay 15, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.9 years ago

Interventions

Denosumabbiological

This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.