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

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ClinicalTrials.gov Identifier: NCT01140321
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : June 9, 2010
Information provided by:

Study Description
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 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

Condition or disease Intervention/treatment Phase
Osteoporosis Thalassemia Major Thalassemia Intermedia Drug: Neridronate Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Therapeutic Trial Evaluating the Efficacy and Safety of Neridronate (Nerixia®) in the Treatment of Osteoporosis in Patients With Thalassemia Major and Severe Thalassemia Intermedia.
Study Start Date : January 2004
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Neridronato
Thalassemia Major or Severe Thalassemia Intermedia
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".
No Intervention: Placebo
Thalassemia Major or Severe Thalassemia Intermedia

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140321

Divisione di Ematologia, Ospedale "Perrino"
Brindisi, Italy
Dipartimento di Medicina Clinica e Sperimentale, Sezione di Pediatria, Università di Ferrara
Ferrara, Italy
Centro della Microcitemia e delle Anemie Congenite - Ematologia E.O. Ospedali Galliera
Genova, Italy, 16128
SC Geriatria E.O. Ospedali Galliera
Genova, Italy, 16128
Centro Anemie Congenite, Ospedale Maggiore Policlinico, IRCCS, University of Milan
Milano,, Italy, 20100
U.O. "Ematologia II con Talassemia" A.O. " V. Cervello
Palermo, Italy
U.O. Pediatria II, A.O. "Villa Sofia"
Palermo, Italy
Centro Microcitemia, A.O. B.M.M.
Reggio Calabria, Italy
Sponsors and Collaborators
Ente Ospedaliero Ospedali Galliera
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Ospedale "Perrino" Brindisi
Reggio Calabria
Azienda Ospedaliera Villa Sofia
Azienda Ospedaliera V. Cervello
Università di Ferrara
University of Campania "Luigi Vanvitelli"
Principal Investigator: Gian Luca Forni, MD Centro della Microcitemia e delle Anemie Congenite E.O. Ospedali Galliera- Genova Italy
Principal Investigator: Ernesto Palummeri, MD S.C. Geriatria E.O. Ospedali Galliera - Genova Italy
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Gian Luca Forni and Prof. Ernesto Palummeri, Centro della Microcitemia e delle Anemia Congenite - Ematologia and S.C. Geriatria
ClinicalTrials.gov Identifier: NCT01140321     History of Changes
Other Study ID Numbers: 60/2003/Nerixia
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by Ente Ospedaliero Ospedali Galliera:

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn