A 12-month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing 150 mg Once-a-month Risedronate and Placebo Using 3-dimensional Micro MRI (Magnetic Resonance Imaging).

TerminadoFase 4ClinicalTrials.gov

ID: NCT00577395Tipo: INTERVENTIONALInicio: 1 de jul de 2008Fin estimado: 1 de feb de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 57 YearsSexo: FEMALE

Criterios de inclusión

Female: 40 and 57 years of age inclusive
cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment
have osteopenia defines as having the following: have osteopenia defined as having the following:
Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR
Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;
have a body mass index (BMI) between 18 and 30 kg/m2.

Criterios de exclusión

history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
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

Intervenciones

drug

placebo

oral tablet once a month for 12 months

drug

risedronate

tablet, 150 mg once a month for 12 months

Ubicaciones

Research Facility

Buenos Aires, Argentina

Patrocinadores

PrincipalWarner Chilcott

ColaboradorSanofi

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