A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00247273Tipo: INTERVENTIONALInicio: 1 de oct de 2005Fin estimado: 1 de abr de 2008

Traducción no disponible, mostrando original

Resumen

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Descripción detallada

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Elegibilidad

Edad mínima: 50 YearsSexo: FEMALE

Criterios de inclusión

Female: 50 years of age or older
\>5 years since last menses natural or surgical
have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Criterios de exclusión

history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
BMI (body mass index) \>32 kg/m\^2
use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
hypocalcemia or hypercalcemia of any cause
markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Intervenciones

drug

risedronate

tablet, 5 mg risedronate, once a day for 2 years

drug

risedronate

oral, 150 mg risedronate, once a month for 2 years

Ubicaciones

Research Site

Buenos Aires, Buenos Aires, Argentina

Research Site

Capital Federal, Argentina

Patrocinadores

PrincipalWarner Chilcott

ColaboradorSanofi

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