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

This study has been completed.
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: April 20, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Osteoporosis, Postmenopausal
Biological: Denosumab

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.

  • Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection [ Time Frame: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively) ] [ Designated as safety issue: No ]
  • Number of Participants Receiving All Prescriptions and Injections of Denosumab [ Time Frame: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively) ] [ Designated as safety issue: No ]
    Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.

  • Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection [ Time Frame: Baseline (day 1) ] [ Designated as safety issue: No ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.

  • Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.

  • Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.

  • Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.

  • Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.

  • Number of Denosumab Post-baseline Injections Received by Each Participant [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of Participants Having Radiologic Bone Assessments [ Time Frame: Pre-baseline (before first denosumab injection) and during the study (post-baseline) ] [ Designated as safety issue: No ]
    Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.

  • Number of Participants Having Osteoporosis Related Laboratory Examinations [ Time Frame: Pre-baseline (before first denosumab injection) and post-baseline ] [ Designated as safety issue: No ]
    Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.


Secondary Outcome Measures:
  • Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).

  • Number of Participants With Serious ADRs to Denosumab [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.


Enrollment: 600
Study Start Date: June 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
Biological: Denosumab
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Other Name: Prolia®

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study was conducted at various study centers in the Czech Republic and Slovakia. Postmenopausal women with osteoporosis who receive an injection of denosumab 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 denosumab 60 mg once every 6 months
  • Have received their first injection of denosumab 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
Research Site
Zlin, Czech Republic, 760 01
Osteocentrum Zlin
Zlin, Czech Republic
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:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652690     History of Changes
Other Study ID Numbers: 20110132 
Study First Received: July 26, 2012
Results First Received: April 20, 2016
Last Updated: April 20, 2016
Health Authority: Czech Republic: Ethics Committee
Slovakia: Ethics Committee

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016