Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and
safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and
Severe Thalassemia Intermedia.
Efficacy and safety of the drug will be evaluated measuring at every visit this parameters:
- haematological: Haemochrome
- blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total
proteins.
The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and
their follow-up will be evaluated at the beginning of the study vs 24 months through physical
examination, abdominal echography and fundus oculi examination.
During the trial other known risks factors for osteoporosis will be recorded, including
prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1.
At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to
evaluate of the presence of bone deformities.
Furthermore data regarding QOL and symptom pain will be evaluated trough administration of
scale SF-36.
At 12 months an intratrial analisis will be performed on efficacy and safety parameters in
order to introduce possible amendments to the study design and to decide the prosecution of
the trial
During the trial all adverse events will be recorded
Phase:
Phase 2
Details
Lead Sponsor:
Ente Ospedaliero Ospedali Galliera
Collaborators:
Azienda Ospedaliera V. Cervello Azienda Ospedaliera Villa Sofia Ospedale "Perrino" Brindisi Ospedale Maggiore Policlinico Mangiagalli e Regina Elena Reggio Calabria Second University of Naples Università di Ferrara University of Campania "Luigi Vanvitelli"