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Completed

NCT Number: NCT01652690

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

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denosumab

Biological

This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.

Other names: Prolia®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • 91320-1799
  • CA
  • One Amgen Center Drive
  • THOUSAND OAKS
  • USA

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2012
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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