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- Ensaio Clínico NCT00129623
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
5 de dezembro de 2015 atualizado por: Hoffmann-La Roche
Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia.
Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly.
The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
160
Estágio
- Fase 4
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
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Colorado
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Lakewood, Colorado, Estados Unidos, 80227
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Florida
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Stuart, Florida, Estados Unidos, 34996
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Maryland
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Bethesda, Maryland, Estados Unidos, 20817
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Michigan
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Detroit, Michigan, Estados Unidos, 48236
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45224
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Oregon
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Portland, Oregon, Estados Unidos, 97213
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Texas
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Amarillo, Texas, Estados Unidos, 79124
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
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Richmond, Virginia, Estados Unidos, 23294
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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
45 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- women 45-60 years of age;
- post-menopausal;
- ambulatory.
Exclusion Criteria:
- vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
- low-trauma osteoporotic fracture in any other bone;
- breast cancer diagnosed within last 20 years;
- other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
- treatment with any bisphosphonate within last 2 years;
- treatment with other drugs affecting bone metabolism within last 6 months.
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 1
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150mg po monthly for 1 year
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Comparador de Placebo: 2
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po monthly for 1 year
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
Prazo: Baseline and Month 12
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BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12.
A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center.
The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)
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Baseline and Month 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12
Prazo: Baseline and Month 12
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BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12.
A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center.
The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.
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Baseline and Month 12
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Relative Change From Baseline in Mean Proximal Femur BMD at Month 12
Prazo: Baseline and Month 12
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BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12.
The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics.
BMD of fractured bones that could impact the scan area were not taken into account.
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Baseline and Month 12
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Absolute Change From Baseline in BMD of the Proximal Femur at Month 12
Prazo: Baseline and Month 12
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BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12.
The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics.
BMD of fractured bones that could impact the scan area were not taken into account.
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Baseline and Month 12
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Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)
Prazo: Baseline and 3, 6 and 12 months
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Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption.
Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
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Baseline and 3, 6 and 12 months
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Absolute Change From Baseline in sCTX
Prazo: Baseline and 3, 6, 12 months
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Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption.
Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
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Baseline and 3, 6, 12 months
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Percentage of Responders
Prazo: Up to 12 months
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Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center.
Proximal femur included total hip, trochanter and femoral neck sites.
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Up to 12 months
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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Up to 15 days after end of study treatment (Approximately 2 years)
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An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
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Up to 15 days after end of study treatment (Approximately 2 years)
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Number of Participants With Marked Laboratory Abnormalities
Prazo: Screening up to 12 months
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Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12.
The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].
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Screening up to 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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
1 de dezembro de 2005
Conclusão Primária (Real)
1 de dezembro de 2007
Conclusão do estudo (Real)
1 de dezembro de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de agosto de 2005
Primeira postagem (Estimativa)
12 de agosto de 2005
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
11 de janeiro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de dezembro de 2015
Última verificação
1 de dezembro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BA18492
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 .
Ensaios clínicos em Osteopenia pós-menopausa
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Uppsala UniversityForensic Toxicology Laboratory, SwedenConcluídoConcentrações séricas | Intoxicação | Concentrações Post MortemSuécia
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SanofiProcter and GambleConcluídoOSTEOPOROSE PÓS-MENOPAUSAL
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Federal University of PelotasDesconhecidoDente Não Vital | Dentadura, Parcial, Removível | Resinas Compostas | Restaurações Metal Cerâmica | Técnica Post e CoreBrasil