NCT01140321: Nerixia

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.

Completed Phase 2 Last updated 3 February 2020

What this trial tests

Phase 2 trial testing Neridronate in Osteoporosis in 120 participants. Completed in 1 May 2010.

Timeline

1 January 2004

Primary endpoint
1 May 2010

1 May 2010

Quick facts

Lead sponsor	Ente Ospedaliero Ospedali Galliera
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 January 2004
Primary completion	1 May 2010
Estimated completion	1 May 2010
Sites	8 locations across Italy

Drugs / interventions tested

• Neridronate (NERIDRONIC ACID) — full drug profile →

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →
• Thalassemia Major — all drugs for Thalassemia Major →
• Thalassemia Intermedia — all drugs for Thalassemia Intermedia →

Sponsor

Ente Ospedaliero Ospedali Galliera — full company profile →

Who can join

18 and older, any sex, with Osteoporosis or Thalassemia Major. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neridronate improves bone mineral density and reduces back pain in β-thalassaemia patients with osteoporosis: results from a phase 2, randomized, parallel-arm, open-label study.
   Forni GL, Perrotta S, Giusti A, Quarta G, et al · · 2012 · cited 32× · PMID 22571408 · DOI 10.1111/j.1365-2141.2012.09152.x