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- Ensaio Clínico NCT00657852
Efficacy of Pamidronate in the Treatment of Bone Loss Associated With Liver Transplant
Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Disodium Pamidronate in the Treatment of Bone Loss Associated With Liver Transplant
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Patients diagnosed with chronic advanced liver disease awaiting orthotopic liver transplantation will be eligible to take part in this study.
Patients excluded from the study will be those younger than 18 years, those receiving a multiorgan transplant or retransplant, or patients with a previous allergy to bisphosphonates. Previous treatment with fluoride, estrogens, selective estrogen receptor modulators or bisphosphonates will be another reason for exclusion, as well as therapy with glucocorticoids during the last 6 months before transplantation. None of the patients will have a previous history of disorders, other than liver disease, known to affect bone metabolism.
Study Design and Conduct
The study will be a 1-year prospective, randomized, double-blind, placebo-controlled trial conducted at 10 centers in Spain.
Immunosuppression
All patients will receive microemulsion cyclosporine A (CsA) as primary immunosuppressive agent, in combination with glucocorticoids. Additionally, mycophenolate mofetil will be associated according to the usual clinical practice of each center. In all cases, glucocorticoids will be progressively tapered during the first year.
Intervention
Patients will receive oral calcium (500 mg twice daily) and oral 25-hydroxy vitamin D (16000 UI every 15 days), after informed consent for the study will be obtained and exploratory screening will be done. Within days 7-12 after engraftment, the recruited transplanted patients (will be randomized to either the experimental or placebo group. Patients of the treatment group will receive a single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion. Patients of the placebo group will receive 500 ml of 5% glucoside serum infusions. Treatment with oral calcium and vitamin D will be maintained for 1 year after transplantation.
Study Endpoints
The primary endpoints of the study will be changes in bone mineral density (BMD), quantified by dual energy X-ray absorptiometry (DXA) and safety of pamidronate by recording adverse events. Secondary endpoints will include the incidence of skeletal fractures, by assessment of radiological vertebral fractures (symptomatic and asymptomatic), and the development of nonvertebral fractures.
Evaluation
Five study visits will be scheduled: before transplantation, within day 7-12 after liver transplantation and at 3, 6 and 12 months after liver transplantation.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Barcelona, Espanha, 08036
- Hospital Clinic i Provincial of Barcelona
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- diagnosed with chronic advanced liver disease awaiting orthotopic liver transplantation
Exclusion Criteria:
- younger than 18 years
- receiving a multiorgan transplant or retransplant
- previous allergy to bisphosphonates
- Previous treatment with fluoride, estrogens, selective estrogen receptor modulators or bisphosphonates
- therapy with glucocorticoids during the last 6 months before transplantation
- previous history of disorders, other than liver disease, known to affect bone metabolism.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Pamidronate
Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion
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Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion
Outros nomes:
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Comparador de Placebo: Placebo
500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion
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500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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bone mineral density (BMD), quantified by dual energy X-ray absorptiometry (DXA)
Prazo: Change during the 1-year of follow up
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Change during the 1-year of follow up
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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adverse events
Prazo: incidence during 1-year of follow-up
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incidence during 1-year of follow-up
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incidence of skeletal fractures, by assessment of radiological vertebral fractures (symptomatic and asymptomatic),
Prazo: 1-year of follow-up
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1-year of follow-up
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incidence of nonvertebral fractures
Prazo: 1-year follow-up
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1-year follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Miquel Navasa, Dr, Hospital Clinic i Provincial, Barcelona
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 99-NV001
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Ensaios clínicos em Disodium pamidronate
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