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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Pract

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.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome:

• 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.
• 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) ]
• 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.
• 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 ]
• 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.
• Typ
  
  

  Original Primary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Number of Prolia® injections received by each patient during the follow-up period [ Time Frame: 24 months from 1st Prolia® injection received ]
  • 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 ]
  • Incidence (yes/no) of patients having osteoporosis related la
    
    

    Current Secondary Outcome:

    • 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).
    • 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.
    
    
    

    Original Secondary Outcome:

    • Incidence (yes/no) of patients with ADR to Prolia®. [ Time Frame: 24 months from 1st Prolia® injection received ]
    • Incidence (yes/no) of patients with serious ADR to Prolia®. [ Time Frame: 24 months from 1st Prolia® injection received ]
    
    
    Information By: Amgen
    

    Dates:
    Date Received: July 26, 2012
    Date Started: June 2012
    Date Completion:
    Last Updated: April 20, 2016
    Last Verified: April 2016