Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis
29 de abril de 2008 actualizado por: Eli Lilly and Company
Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1637
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Capital Federal, Argentina
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Nedlands, Australia
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Graz, Austria
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Brussels, Bélgica
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Alberta
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Calgary, Alberta, Canadá
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Aarhus, Dinamarca
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
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Kuopio, Finlandia
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Szeged, Hungría
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Tel-Hashomer, Israel
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Arenzano, Italia
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Kristiansand, Noruega
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Christchurch, Nueva Zelanda
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Amsterdam, Países Bajos
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Warszawa, Polonia
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Praha, República Checa
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Uppsala, Suecia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
30 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Ambulatory, postmenopausal women.
- A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
- Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
- Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal & 3 times the upper limit of normal at baseline).
Exclusion Criteria:
- Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
- Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
- Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
- Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
- Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.
- Nephrolithiasis or urolithiasis in the 2 years prior to randomization.
- Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level.
- Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator.
- Treatment with androgens or other anabolic steroids in the 6 months prior to randomization.
- Treatment with calcitonins in the 2 months prior to randomization.
- Treatment with estrogen
- Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization.
- Treatment with corticosteroids.
- Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization.
- Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization.
- Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal.
- Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization.
- Treatment with calcium- or aluminum-containing antacids
- Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization.
- Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium & vitamin D run-in phase.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
LY333334 40 micrograms/day plus calcium and vitamin D
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40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Otros nombres:
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Otros nombres:
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
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Experimental: 2
LY333334 20 micrograms/day plus calcium and vitamin D
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40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Otros nombres:
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Otros nombres:
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
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Comparador de placebos: 3
Placebo plus calcium and vitamin D
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Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
Periodo de tiempo: Baseline, randomization, 24 , 36, and 60 months
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Baseline, randomization, 24 , 36, and 60 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis
Periodo de tiempo: Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
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Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
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To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites
Periodo de tiempo: Randomization, 12, 24, 36, 48 and 60 months
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Randomization, 12, 24, 36, 48 and 60 months
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To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.
Periodo de tiempo: Baseline, randomization, 24 months, 60 months
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Baseline, randomization, 24 months, 60 months
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To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.
Periodo de tiempo: As clinically needed throughout the trial
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As clinically needed throughout the trial
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To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis
Periodo de tiempo: Randomization, 12, 24, 36, 48, and 60 months
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Randomization, 12, 24, 36, 48, and 60 months
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To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.
Periodo de tiempo: Randomization, 12 and 24 months
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Randomization, 12 and 24 months
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To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)
Periodo de tiempo: Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
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Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
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To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.
Periodo de tiempo: Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
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Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
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To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.
Periodo de tiempo: Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
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Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
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To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.
Periodo de tiempo: Randomization, 12, 24, 36, 48, and 60 months
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Randomization, 12, 24, 36, 48, and 60 months
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To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.
Periodo de tiempo: Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months
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Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Call 1-877-CT LILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 1996
Finalización primaria (Actual)
1 de abril de 1999
Finalización del estudio (Actual)
1 de abril de 1999
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2008
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2008
Publicado por primera vez (Estimar)
1 de mayo de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de mayo de 2008
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2008
Última verificación
1 de abril de 2008
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Enfermedades musculoesqueléticas
- Enfermedades óseas
- Enfermedades Óseas Metabólicas
- Osteoporosis
- Osteoporosis Posmenopáusica
- Efectos fisiológicos de las drogas
- Micronutrientes
- Vitaminas
- Agentes de conservación de la densidad ósea
- Hormonas y agentes reguladores del calcio
- Vitamina D
- Calcio
- Teriparatida
Otros números de identificación del estudio
- 547
- B3D-MC-GHAC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .