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

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ClinicalTrials.gov Identifier: NCT01652690
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : May 26, 2016
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
One Amgen Center Drive
THOUSAND OAKS
CA
91320-1799
USA
Information provided by (Responsible Party):
Amgen

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal Biological: Denosumab

Study Design
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Study Type : Observational
Actual Enrollment : 600 participants
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
Actual Study Start Date : June 26, 2012
Actual Primary Completion Date : May 15, 2015
Actual Study Completion Date : May 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office [ Time Frame: 24 months ]
    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.

  2. 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) ]
  3. 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) ]
    Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.

  4. 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 ]
  5. Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection [ Time Frame: Baseline (day 1) ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.

  6. Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection [ Time Frame: Month 6 ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.

  7. Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection [ Time Frame: Month 12 ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.

  8. Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection [ Time Frame: Month 18 ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.

  9. Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection [ Time Frame: Month 24 ]
    Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.

  10. Number of Denosumab Post-baseline Injections Received by Each Participant [ Time Frame: 24 months ]
  11. Number of Participants Having Radiologic Bone Assessments [ Time Frame: Pre-baseline (before first denosumab injection) and during the study (post-baseline) ]
    Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.

  12. Number of Participants Having Osteoporosis Related Laboratory Examinations [ Time Frame: Pre-baseline (before first denosumab injection) and post-baseline ]
    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 :
  1. Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab [ Time Frame: 24 months ]
    Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).

  2. Number of Participants With Serious ADRs to Denosumab [ Time Frame: 24 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652690


Locations
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Czechia
Research Site
Brno, Czechia, 602 00
Research Site
Brno, Czechia, 638 00
Research Site
Ceske Budejovice, Czechia, 370 01
Research Site
Havlickuv Brod, Czechia, 580 22
Research Site
Karlovy Vary, Czechia, 367 17
Research Site
Kutna Hora, Czechia, 284 01
Research Site
Ostrava-Trebovice, Czechia, 722 00
Research Site
Ostrava, Czechia, 702 00
Research Site
Plzen, Czechia, 323 00
Research Site
Praha 11, Czechia, 148 00
Research Site
Praha 2, Czechia, 128 50
Research Site
Praha 4 - Nusle, Czechia, 140 00
Research Site
Trutnov, Czechia, 541 21
Research Site
Vsetin, Czechia, 755 01
Research Site
Zlin, Czechia, 760 01
Osteocentrum Zlin
Zlin, Czechia
Slovakia
Research Site
Banska Bystrica, Slovakia, 974 01
Research Site
Bratislava, Slovakia, 826 06
Research Site
Bratislava, Slovakia, 833 05
Research Site
Humenne, Slovakia, 066 01
Research Site
Kosice-Saca, Slovakia, 040 15
Research Site
Kosice, Slovakia, 040 01
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
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652690    
Other Study ID Numbers: 20110132
First Posted: July 30, 2012    Key Record Dates
Results First Posted: May 26, 2016
Last Update Posted: March 6, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs