PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

CompletadoFase 3ClinicalTrials.gov

ID: NCT00141323Tipo: INTERVENTIONALInicio: 1 de nov de 2001Fin estimado: 1 de dic de 2007

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.

Elegibilidad

Edad mínima: 60 YearsEdad máxima: 80 YearsSexo: FEMALE

Criterios de inclusión

Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Criterios de exclusión

Metabolic bone disease other than osteoporosis; Taking approved medications for osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Intervenciones

drug

lasofoxifene

0.5 mg once per day, orally

other

placebo

drug

lasofoxifene

0.25 mg once per day, orally

Ubicaciones

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Pfizer Investigational Site

Capital Federal - Buenos Aires, Argentina

Pfizer Investigational Site

Capital Federal, Argentina

Pfizer Investigational Site

Capital Federal, Argentina

Pfizer Investigational Site

S2000dhl- Rosario - Santa Fe, Argentina

Patrocinadores

PrincipalLigand Pharmaceuticals

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