Calendario›SNY›RISEDRONATE

RISEDRONATE

Risedronate in Postmenopausal Women With Low Bone Density

Ensayo de Sanofi en OSTEOPOROSIS, POSTMENOPAUSAL (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

150

previstos

Fin del objetivo primario

jun 2003

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en nov 2002.

Qué mide

Urine NTX at week 4 of month 6 (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months The secondary objectives are : * To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate. * To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate. * To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate. * To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.

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Ficha completa en ClinicalTrials.gov (NCT00351091), actualizada en feb 2012.