Observational Study of Prolia® in Postmenopausal Women With Osteoporosis

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 16, 2012
Last updated: January 13, 2015
Last verified: January 2015

The study is being performed to describe Prolia® patients' medication-taking behavior in a non-interventional routine clinical care setting

Postmenopausal Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Evaluate Medication-Taking Behavior With Denosumab (Prolia®) and Patient Characteristics in Postmenopausal Women With Osteoporosis in Routine Clinical Practice in Germany, Austria and Greece

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Medication taking-behavior [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse drug reactions and serious adverse drug reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 1501
Study Start Date: November 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal women indicated for treatment of osteoporosis at increased risk of fractures according to the approval regional prescribing information, e.g. EU SmPC


Inclusion Criteria:

  • Indicated for treatment of OP in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (e.g. EU SmPC in Germany, Austria and Greece)
  • Enrolled into the study within 4 weeks of receiving their first injection of denosumab (Prolia®) according to the approved Regional Prescribing Information (e.g. EU SmPC in Germany, Austria and Greece)
  • Appropriate written informed consent has been obtained (as required per local country regulations).

Exclusion Criteria:

  • Subject is currently enrolled in or has not yet completed at least 6 months since ending any investigational procedure, device or drug trial(s), or subject is receiving any investigational agent(s)
  • Contra-indicated for treatment with Prolia® according to the approved Regional Prescribing Information (e.g. EU SmPC in Germany, Austria and Greece)
  • Participation in ongoing or previous denosumab clinical trials
  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01668589

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Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01668589     History of Changes
Other Study ID Numbers: 20110126
Study First Received: August 16, 2012
Last Updated: January 13, 2015
Health Authority: Greece: Ethics Committee
Austria: Ethikkommission
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 26, 2015