A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men

CompletadoFase 3ClinicalTrials.gov

ID: NCT00439647Tipo: INTERVENTIONALInicio: 1 de dic de 2006Fin estimado: 1 de oct de 2010

Traducción no disponible, mostrando original

Resumen

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 85 YearsSexo: MALE

Criterios de inclusión

• Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae

Criterios de exclusión

Low Vitamin D
Renal insufficiency
Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate,
Previous treatment with testosterone, anabolic steroids or growth hormone
Chronic use of systemic corticosteroids (oral or i.v.) within the last year
History of any cancer or metastases within the last 5 years
History of brittle bone disease, multiple myeloma, or Paget's disease, or any other metabolic bone disease, except osteoporosis
Bilateral hip replacements

Intervenciones

drug

Zoledronic acid 5 mg iv

Zoledronic acid 5 mg iv given once a year.

drug

Placebo

Placebo intravenous (i.v.) once a year

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Mar del Plata, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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