Alendronate Versus Placebo for Idiopathic Juvenile Osteoporosis
Alendronate
Enfermedades de los Huesos+6
+ Enfermedades Óseas Metabólicas
+ Enfermedades metabólicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1998
Fecha en la que se inscribió al primer participante.Osteoporosis is a rare but serious condition in children. One of the least well understood forms of childhood osteoporosis is idiopathic juvenile osteoporosis. Affected children suffer from pain, decreased activity tolerance, and increased fractures, including vertebral compression fractures. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a lower peak bone mass during the first 2-3 decades of life may be at increased risk for osteoporosis as adults. Alendronate (Fosamax (Trademark), Merck & Co.), an aminobisphosphonate, is a potent inhibitor of bone resorption. It has been used to treat postmenopausal osteoporosis, idiopathic male osteoporosis, and glucocorticoid induced osteoporosis in adults. The goal of this protocol is to evaluate the effectiveness of Alendronate in children with glucocorticoid induced and idiopathic juvenile osteoporosis using a double-blind, randomized, placebo-controlled study design. We hypothesize that children treated with this drug will have an improvement in bone mineral density and decrease in osteoporotic fractures.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
INCLUSION CRITERIA: Chronological age: 6.0 - 17.0 years. Study population will be restricted to children greater than 12 years of age until 8 patients have completed 6 months of the study or safety data is available from a comparable study. AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age matched controls (z-score) using Hologic QDR machine. Normative data published by Faulkner will be used to calculate Z-scores. Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared to age-matched controls) in a child with no identifiable etiology. Children with IJO and delayed puberty will have their z-score calculated on the basis of bone age. EXCLUSION CRITERIA: Inability to swallow pills or comply with administration instructions. Upper gastrointestinal tract disease. Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters. Prior treatment with bisphosphonates. Concurrent therapy with oral aspirin or salicylate containing compounds, excluding delayed-release salicylates which act in the distal gastrointestinal tract (for example, mesalamine, sulfasalazine, etc...). Hypocalcemia. Treatment with hGH or calcitonin in the preceding 6 months. Inability to undergo dual energy x-ray absorptiometry. Positive pregnancy test. In females, sexual activity without an effective method of contraception.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Institute of Child Health and Human Development (NICHD)
Bethesda, United StatesAbrir National Institute of Child Health and Human Development (NICHD) en Google Maps