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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
One Amgen Center Drive
THOUSAND OAKS
CA
91320-1799
USA
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01652690
First received: July 26, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with Prolia® (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.


Condition Intervention
Osteoporosis, Postmenopausal
Drug: Prolia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Prolia® in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence (yes/no) of patients receiving all prescriptions and injections of Prolia® from the initial prescribing physician's office [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]
  • Incidence (yes/no) of patients receiving an individual prescription and injection of Prolia® from the initial prescribing physician office by each individual injection [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]
  • Incidence (yes/no) of patients receiving all prescriptions and injections of Prolia®, whether or not the injections are given at the initial prescribing physician's office [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]
  • Incidence (yes/no) of patients with a referral by the prescribing physician to other health care providers for continuation or follow up of care by type of physician [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]
  • Types of health care providers administering an individual injection of Prolia® inside or outside the initial prescribing office by injection [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]
  • Number of Prolia® injections received by each patient during the follow-up period [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]
  • Incidence (yes/no) of patients having radiologic bone assessments pre-treatment with Prolia®, and during the study [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]
  • Incidence (yes/no) of patients having osteoporosis related laboratory examinations pre-treatment with Prolia®, and during the study. [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence (yes/no) of patients with ADR to Prolia®. [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: Yes ]
  • Incidence (yes/no) of patients with serious ADR to Prolia®. [ Time Frame: 24 months from 1st Prolia® injection received ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prolia naive PMO women
Prolia® naive PMO patients will be eligible to enroll within 8 weeks after initiation of Prolia® treatment (ie 8 weeks after receiving the first injection).
Drug: Prolia
This is an non-interventional study, therefore Prolia is adminstered as part of routine care and not for purposes of the study.
Other Name: Denosumab

  Eligibility

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

Postmenopausal women with OP who receive an injection of Prolia® and meet the inclusion/exclusion criteria will be eligible to participate in the study.

Criteria

Inclusion Criteria Women with a clinical diagnosis of postmenopausal osteoporosis Decision has been made to treat with Prolia® 60 mg once every 6 months Have received their first injection of Prolia® within 8 weeks prior to enrolling in this study.

Appropriate written informed consent has been obtained (as required per local country regulations)

Exclusion Criteria Participating in ongoing or have participated in previous denosumab clinical trials 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

  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: NCT01652690

Locations
Czech Republic
Research Site
Brno, Czech Republic, 602 00
Research Site
Brno, Czech Republic, 638 00
Research Site
Ceske Budejovice, Czech Republic, 370 01
Research Site
Havlickuv Brod, Czech Republic, 580 22
Research Site
Karlovy Vary, Czech Republic, 367 17
Research Site
Kutna Hora, Czech Republic, 284 01
Research Site
Ostrava, Czech Republic, 702 00
Research Site
Ostrava-Trebovice, Czech Republic, 722 00
Research Site
Plzen, Czech Republic, 323 00
Research Site
Praha 11, Czech Republic, 148 00
Research Site
Praha 2, Czech Republic, 128 50
Research Site
Praha 4 - Nusle, Czech Republic, 140 00
Research Site
Trutnov, Czech Republic, 541 21
Research Site
Vsetin, Czech Republic, 755 01
Osteocentrum Zlin
Zlin, Czech Republic
Research Site
Zlin, Czech Republic, 760 01
Slovakia
Research Site
Banska Bystrica, Slovakia, 974 01
Research Site
Bratislava, Slovakia, 833 05
Research Site
Bratislava, Slovakia, 826 06
Research Site
Humenne, Slovakia, 066 01
Research Site
Kosice, Slovakia, 040 01
Research Site
Kosice-Saca, Slovakia, 040 15
Research Site
Lubochna, Slovakia, 034 91
Research Site
Lucenec, Slovakia, 984 01
Research Site
Martin, Slovakia, 036 01
Research Site
Nitra, Slovakia, 949 01
Research Site
Presov, Slovakia, 080 01
Research Site
Trnava, Slovakia, 917 75
Research Site
Zilina, Slovakia, 010 01
Sponsors and Collaborators
Amgen
One Amgen Center Drive
THOUSAND OAKS
CA
91320-1799
USA
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652690     History of Changes
Other Study ID Numbers: 20110132
Study First Received: July 26, 2012
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014