A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

CompletadoFase 3ClinicalTrials.gov

ID: NCT01575873Tipo: INTERVENTIONALInicio: 28 de mar de 2012Fin estimado: 29 de jun de 2017

Traducción no disponible, mostrando original

Resumen

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men and women who are less than 50 years of age must have had a fracture as an adult to be eligible. Men and women who are 50 years of age or older who have been taking glucocorticoids must meet protocol-specific BMD criteria.

Criterios de exclusión

Use of agents affecting bone metabolism, use of more than one biologic agent for inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level (one can enter the trial after vitamin D levels are corrected), abnormalities of blood calcium, an underactive or overactive thyroid condition that is not treated and stable, Addison's disease, any abnormality of the parathyroid glands (the glands that control blood calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other criteria may apply.

Intervenciones

drug

Denosumab

Administered by subcutaneous injection once every 6 months

drug

Placebo for risendronate

Administered orally once a day

drug

Risendronate

Administered orally once a day

drug

Placebo for denosumab

Administered by subcutaneous injection once every 6 months

Ubicaciones

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalAmgen

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