A Multicenter, International, Randomized, Double-blind, P... | EligiMed

A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

CompletadoFase 3ClinicalTrials.gov

ID: NCT01575834Tipo: INTERVENTIONALInicio: 15 de mar de 2012Fin estimado: 28 de dic de 2016

Endocrinología Traumatología y Ortopedia

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Elegibilidad

Edad mínima: 55 YearsEdad máxima: 90 YearsSexo: FEMALE

Criterios de inclusión

\- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Criterios de exclusión

BMD T-score of ≤ -3.50 at the total hip or femoral neck
History of hip fracture
Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
Use of agents affecting bone metabolism
History of metabolic or bone disease (except osteoporosis)
Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
Current hyper- or hypocalcemia
Current, uncontrolled hyper- or hypothyroidism
Current, uncontrolled hyper- or hypoparathyroidism

Intervenciones

drug

Romosozumab

Administered by subcutaneous injection once a month (QM)

drug

Placebo

Administered by subcutaneous injection once a month (QM)

drug

Denosumab

Administered by subcutaneous injection once every 6 months (Q6M)

Ubicaciones

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Mar del Plata, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalAmgen

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