A Non-inferiority Comparison of 35 mg Delayed-release Ris... | EligiMed

A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00541658Tipo: INTERVENTIONALInicio: 1 de oct de 2007Fin estimado: 1 de abr de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly 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 35 mg delayed release given weekly and 5 mg immediate release given 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 or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip 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 \>32 kg/m
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

5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily

drug

risedronate

35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly

drug

risedronate

35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly

Ubicaciones

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalWarner Chilcott

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