Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
4 de março de 2019 atualizado por: 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.
Visão geral do estudo
Tipo de estudo
Observacional
Inscrição (Real)
600
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Banska Bystrica, Eslováquia, 974 01
- Research Site
-
Bratislava, Eslováquia, 826 06
- Research Site
-
Bratislava, Eslováquia, 833 05
- Research Site
-
Humenne, Eslováquia, 066 01
- Research Site
-
Kosice, Eslováquia, 040 01
- Research Site
-
Kosice-Saca, Eslováquia, 040 15
- Research Site
-
Lubochna, Eslováquia, 034 91
- Research Site
-
Lucenec, Eslováquia, 984 01
- Research Site
-
Martin, Eslováquia, 036 01
- Research Site
-
Nitra, Eslováquia, 949 01
- Research Site
-
Presov, Eslováquia, 080 01
- Research Site
-
Trnava, Eslováquia, 917 75
- Research Site
-
Zilina, Eslováquia, 010 01
- Research Site
-
-
-
-
-
Brno, Tcheca, 602 00
- Research Site
-
Brno, Tcheca, 638 00
- Research Site
-
Ceske Budejovice, Tcheca, 370 01
- Research Site
-
Havlickuv Brod, Tcheca, 580 22
- Research Site
-
Karlovy Vary, Tcheca, 367 17
- Research Site
-
Kutna Hora, Tcheca, 284 01
- Research Site
-
Ostrava, Tcheca, 702 00
- Research Site
-
Ostrava-Trebovice, Tcheca, 722 00
- Research Site
-
Plzen, Tcheca, 323 00
- Research Site
-
Praha 11, Tcheca, 148 00
- Research Site
-
Praha 2, Tcheca, 128 50
- Research Site
-
Praha 4 - Nusle, Tcheca, 140 00
- Research Site
-
Trutnov, Tcheca, 541 21
- Research Site
-
Vsetin, Tcheca, 755 01
- Research Site
-
Zlin, Tcheca, 760 01
- Research Site
-
Zlin, Tcheca
- Osteocentrum Zlin
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
|
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 24 months
|
24 months
|
|
|
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 24 months
|
24 months
|
|
|
Number of Participants Having Radiologic Bone Assessments
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
26 de junho de 2012
Conclusão Primária (Real)
15 de maio de 2015
Conclusão do estudo (Real)
15 de maio de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
26 de julho de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de julho de 2012
Primeira postagem (Estimativa)
30 de julho de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de março de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de março de 2019
Última verificação
1 de março de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20110132
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .