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

4 marzo 2019 aggiornato da: Amgen

Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Effettivo)

600

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cechia
      • Brno, Cechia, 602 00
        • Research Site
      • Brno, Cechia, 638 00
        • Research Site
      • Ceske Budejovice, Cechia, 370 01
        • Research Site
      • Havlickuv Brod, Cechia, 580 22
        • Research Site
      • Karlovy Vary, Cechia, 367 17
        • Research Site
      • Kutna Hora, Cechia, 284 01
        • Research Site
      • Ostrava, Cechia, 702 00
        • Research Site
      • Ostrava-Trebovice, Cechia, 722 00
        • Research Site
      • Plzen, Cechia, 323 00
        • Research Site
      • Praha 11, Cechia, 148 00
        • Research Site
      • Praha 2, Cechia, 128 50
        • Research Site
      • Praha 4 - Nusle, Cechia, 140 00
        • Research Site
      • Trutnov, Cechia, 541 21
        • Research Site
      • Vsetin, Cechia, 755 01
        • Research Site
      • Zlin, Cechia, 760 01
        • Research Site
      • Zlin, Cechia
        • Osteocentrum Zlin
  • Slovacchia
      • Banska Bystrica, Slovacchia, 974 01
        • Research Site
      • Bratislava, Slovacchia, 826 06
        • Research Site
      • Bratislava, Slovacchia, 833 05
        • Research Site
      • Humenne, Slovacchia, 066 01
        • Research Site
      • Kosice, Slovacchia, 040 01
        • Research Site
      • Kosice-Saca, Slovacchia, 040 15
        • Research Site
      • Lubochna, Slovacchia, 034 91
        • Research Site
      • Lucenec, Slovacchia, 984 01
        • Research Site
      • Martin, Slovacchia, 036 01
        • Research Site
      • Nitra, Slovacchia, 949 01
        • Research Site
      • Presov, Slovacchia, 080 01
        • Research Site
      • Trnava, Slovacchia, 917 75
        • Research Site
      • Zilina, Slovacchia, 010 01
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
Biologico: Denosumab
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Altri nomi:
  • Prolia®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Lasso di tempo: 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.
24 months
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Lasso di tempo: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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
Lasso di tempo: 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.
Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Lasso di tempo: 24 months
24 months
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Lasso di tempo: 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.
Baseline (day 1)
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Lasso di tempo: 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.
Month 6
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Lasso di tempo: 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.
Month 12
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Lasso di tempo: 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.
Month 18
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Lasso di tempo: 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.
Month 24
Number of Denosumab Post-baseline Injections Received by Each Participant
Lasso di tempo: 24 months
24 months
Number of Participants Having Radiologic Bone Assessments
Lasso di tempo: 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.
Pre-baseline (before first denosumab injection) and during the study (post-baseline)
Number of Participants Having Osteoporosis Related Laboratory Examinations
Lasso di tempo: 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.
Pre-baseline (before first denosumab injection) and post-baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Lasso di tempo: 24 months
Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
24 months
Number of Participants With Serious ADRs to Denosumab
Lasso di tempo: 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.
24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Collaboratori

One Amgen Center Drive
THOUSAND OAKS
CA
91320-1799
USA

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 giugno 2012

Completamento primario (Effettivo)

15 maggio 2015

Completamento dello studio (Effettivo)

15 maggio 2015

Date di iscrizione allo studio

Primo inviato

26 luglio 2012

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2012

Primo Inserito (Stima)

30 luglio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20110132

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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