Status:
COMPLETED
Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI
Lead Sponsor:
Ente Ospedaliero Ospedali Galliera
Collaborating Sponsors:
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Ospedale "Perrino" Brindisi
Conditions:
Osteoporosis
Thalassemia Major
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Thalas...
Detailed Description
Aim of the Study At present, due to the global therapeutic approach, the prognosis of Thalassemia Major and Severe Thalassemia Intermedia is open-ended. Regular transfusional regimens from childhood a...
Eligibility Criteria
Inclusion
- Patients presenting BMD Z score \<-2 at the level of the femoral neck or of the lumbar column Regular transfusional regimen in order to mantain pre-transfusional Hb values \>9 g/dl.
- Written informed consent by the patient
Exclusion
- Entravenous administration of bisphosphonates within the past 2 years
- Administration of di bisphosphonates per os, unless wash out as it follows:
- 1 year if \>8 weeks \<48 weeks 6 months if \> 2 weeks and \<8 weeks Hypoparathyroidism Thalassemia Intermedia if not regularly transfused Pregnancy and breast feeding Impaired renal function (creat. \> 1.5 mg/dl) Neoplastic disease Patients with mean levels of alanine aminotransferase ALT \> 300 U/l and patients with variations of AST or AST of 300% within the year before randomization. (At least 4 misurations over 12 months) Systemic cardiovascular, renal, hepatic disease etc. which would prevent the patient from undergoing study treatment Known hypersensibility to bisphosphonates. History of non compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01140321
Start Date
January 1 2004
End Date
May 1 2010
Last Update
February 5 2020
Active Locations (8)
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1
Divisione di Ematologia, Ospedale "Perrino"
Brindisi, Italy
2
Dipartimento di Medicina Clinica e Sperimentale, Sezione di Pediatria, Università di Ferrara
Ferrara, Italy
3
Centro della Microcitemia e delle Anemie Congenite - Ematologia E.O. Ospedali Galliera
Genova, Italy, 16128
4
SC Geriatria E.O. Ospedali Galliera
Genova, Italy, 16128