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- Ensaio Clínico NCT00303485
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
30 de março de 2016 atualizado por: Hoffmann-La Roche
A Randomized, Double-blind, Placebo-controlled Study to Determine Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once Monthly Ibandronate in the Treatment of Postmenopausal Osteoporosis
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.
Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation.
The anticipated time on study treatment is approximately 7 months, and the target sample size is <100 individuals.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
67
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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California
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Beverly Hills, California, Estados Unidos, 90211
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La Jolla, California, Estados Unidos, 92093
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Georgia
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Augusta, Georgia, Estados Unidos, 30904
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Minnesota
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Woodbury, Minnesota, Estados Unidos, 55125
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New York
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Bronx, New York, Estados Unidos, 10461
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Pennsylvania
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Hopwood, Pennsylvania, Estados Unidos, 15445
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
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Ponce, Porto Rico, 00717-1318
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San Juan, Porto Rico, 00935
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San Juan, Porto Rico, 00927
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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
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
- naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.
Exclusion Criteria:
- patients on hormone replacement therapy (HRT) within the last 3 months;
- patients on other osteoporosis medication within the last 3 months;
- sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
- hypersensitivity to any component of ibandronate;
- contraindication for calcium or vitamin D therapy;
- history of major gastrointestinal upset;
- malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).
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: Ibandronate
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
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150mg via oral mensalmente por 6 meses
As prescribed
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Comparador de Placebo: Placebo
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
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As prescribed
po monthly for 6 months
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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 Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3
Prazo: Baseline (Visit 1) and Day 3
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Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body.
It is measured in units of nanograms (ng) per milliliter (mL).
The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) * 100.
The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening.
If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1) and Day 3
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
Prazo: Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6
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sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body.
The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) * 100.
The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening.
If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6
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Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
Prazo: Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6
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BSAP is a biochemical marker of bone formation and measured in units per litre (U/L).
The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) * 100.
The greater the percent decrease from Baseline, the greater the response to therapy.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6
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Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments
Prazo: Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7
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Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL).
The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) * 100.
Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7
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Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7
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Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
Prazo: Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6
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The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline.
Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6
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Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
Prazo: Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points.
Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
Prazo: Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points.
Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.
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Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations
Prazo: Day (D)7, D14, D21 and D28 of Month 6
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Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.
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Day (D)7, D14, D21 and D28 of Month 6
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Number of Participants With Any Marked Abnormality in Laboratory Parameters
Prazo: Up to 7 months
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Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount.
The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 - 550 *10^9/L), white blood cell (WBC) (3.0 - 18.0 *10^9/L), alanine aminotransferase (ALT) (0 - 110 U/L), creatinine (0 - 154 µmol/L), chloride (95 - 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ).
Creatinine clearance was calculated using the Cockroft-Gault formula.
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Up to 7 months
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Number of Participants With Any Adverse Event or Serious Adverse Event
Prazo: Up to 7 months
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An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
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Up to 7 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 fevereiro de 2006
Conclusão Primária (Real)
1 de junho de 2007
Conclusão do estudo (Real)
1 de junho de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
16 de março de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de março de 2006
Primeira postagem (Estimativa)
17 de março de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de maio de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de março de 2016
Última verificação
1 de março de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Metabólicas
- Doenças musculoesqueléticas
- Doenças ósseas
- Doenças Ósseas Metabólicas
- Osteoporose
- Osteoporose, pós-menopausa
- Efeitos Fisiológicos das Drogas
- Micronutrientes
- Vitaminas
- Agentes de Conservação da Densidade Óssea
- Hormônios e Agentes Reguladores de Cálcio
- Vitamina D
- Cálcio
- Ácido Ibandrônico
Outros números de identificação do estudo
- ML19334
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 .
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