Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

May 31, 2010

Study Completion Date

May 31, 2010

Conditions
OsteoporosisThalassemia MajorThalassemia Intermedia
Interventions
DRUG

Neridronate

"Neridronate is an aminobisphosfonate of third generation that has been proved in several clinical trials to have the ability to inhibit osteoclast-mediated bone resorption and it is generally well tollerated also at high doses. Thanks to these properties it has been used in the treatment of several bone disorders such as Paget's disease and Osteogenesis Imperfecta. Neridronate, given intravenously or orally (tablets), reduces both the levels of bone alcaline phosphatase and of the other markers of bone resorption activity. Recently it has been approved by the Italian Ministry of Health for the commercialization with the indication Osteogenesis Imperfecta."

Trial Locations (8)

16128

Centro della Microcitemia e delle Anemie Congenite - Ematologia E.O. Ospedali Galliera, Genova

SC Geriatria E.O. Ospedali Galliera, Genova

20100

Centro Anemie Congenite, Ospedale Maggiore Policlinico, IRCCS, University of Milan, Milan

Unknown

"Divisione di Ematologia, Ospedale Perrino", Brindisi

Dipartimento di Medicina Clinica e Sperimentale, Sezione di Pediatria, Università di Ferrara, Ferrara

"U.O. Ematologia II con Talassemia A.O. V. Cervello", Palermo

"U.O. Pediatria II, A.O. Villa Sofia", Palermo

Centro Microcitemia, A.O. B.M.M., Reggio Calabria

All Listed Sponsors
collaborator

Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

OTHER

collaborator

"Ospedale Perrino Brindisi"

UNKNOWN

collaborator

Reggio Calabria

OTHER

collaborator

Azienda Ospedaliera Villa Sofia

UNKNOWN

collaborator

Azienda Ospedaliera V. Cervello

OTHER

collaborator

Università di Ferrara

UNKNOWN

collaborator

University of Campania Luigi Vanvitelli

OTHER

lead

Ente Ospedaliero Ospedali Galliera

OTHER

NCT01140321 - Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI | Biotech Hunter | Biotech Hunter