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

NCT01652690 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2019-03-06

Study results available
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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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

BIOLOGICAL

Denosumab

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

Sponsors & Collaborators

  • One Amgen Center Drive

    collaborator UNKNOWN

  • THOUSAND OAKS

    collaborator UNKNOWN

  • CA

    collaborator UNKNOWN

  • 91320-1799

    collaborator UNKNOWN

  • USA

    collaborator UNKNOWN

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-26
Primary Completion
2015-05-15
Completion
2015-05-15

Countries

  • Czechia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01652690 on ClinicalTrials.gov