Observational Study of Prolia® in Postmenopausal Women With Osteoporosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01668589
First received: August 16, 2012
Last updated: June 18, 2015
Last verified: June 2015
  Purpose

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


Condition
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, Greece and Belgium

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 ]

Other Outcome Measures:
  • Time to non persistence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of Prolia® injections within the specified window [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Incidence of serious and non-serious ADRs [ Time Frame: 24 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)
  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug.
  • Contraindicated for treatment with Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
  • Participation in ongoing or previous denosumab clinical trials.
  • Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668589

  Show 144 Study Locations
Sponsors and Collaborators
Amgen
Investigators
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: June 18, 2015
Health Authority: Greece: Ethics Committee
Austria: Ethikkommission
Germany: Paul-Ehrlich-Institut
Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on June 28, 2015