Treatment of complex regional pain syndrome type I with neridronate: a randomized, double-blind, placebo-controlled study

Varenna, M.; Adami, Silvano; Rossini, Maurizio; Gatti, Davide; Idolazzi, Luca; Zucchi, F.; Malavolta, N; Sinigaglia, Luigi

doi:10.1093/rheumatology/kes312

Cited by 128 publications

(88 citation statements)

References 22 publications

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“…All bisphosphonates developed so far for the treatment of either focal bone disorders or osteoporosis reduce bone turnover in a dose-dependent manner, with proportional increases in bone density. The intestinal absorption of bisphosphonates is only 0. algodystrophy (complex regional pain syndrome type I), based on data from a recent randomized controlled trial (112).…”

Section: Bisphosphonatesmentioning

confidence: 99%

Guidelines for the diagnosis, prevention and management of osteoporosis

et al. 2016

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Osteoporosis poses a significant public health issue. National Societies have developed Guidelines for the diagnosis and treatment of this disorder with an effort of adapting specific tools for risk assessment on the peculiar characteristics of a given population. The Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS) has recently revised the previously published Guidelines on the diagnosis, riskassessment, prevention and management of primary and secondary osteoporosis. The guidelines were first drafted by a working group and then approved by the board of SIOMMMS. Subsequently they received also the endorsement of other major Scientific Societies that deal with bone metabolic disease. These recommendations are based on systematic reviews of the best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on leading experts' experience and opinion, and on good clinical practice. The osteoporosis prevention should be based on the elimination of specific risk factors. The use of drugs registered for the treatment of osteoporosis are recommended when the benefits overcome the risk, and this is the case only when the risk of fracture is rather high as measured with variables susceptible to pharmacological effect. DeFRA (FRAX® derived fracture risk assessment) is recognized as a useful tool for easily estimate the long-term fracture risk. Several secondary forms of osteoporosis require a specific diagnostic and therapeutic management

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Section: Bisphosphonatesmentioning

confidence: 99%

Guidelines for the diagnosis, prevention and management of osteoporosis

et al. 2016

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“…A complete normalization of the abnormal uptake was reported in patients undergoing bone scintigraphy, and a disappearance of localized bone oedema was observed on MRIs from 12 treated patients. 38 …”

Section: Paget's Disease Of Bonementioning

confidence: 99%

Neridronate: From Experimental Data to Clinical Use

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2017

Clinical Medicine Insights: Therapeutics

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Neridronate is an amino-bisphosphonate that has been officially approved as a treatment for osteogenesis imperfecta, Paget’s disease of bone and type I complex regional pain syndrome in Italy. Neridronate is administered either intravenously or intramuscularly; thus, it represents a valid option for both cases with contraindications to the use of oral bisphosphonates and cases with contraindications or an inability to receive an intravenous administration of these drugs. Furthermore, although the official authorized use of neridronate is limited to only 3 bone diseases, many experimental and clinical studies support the rationale for its use and provide evidence of its effectiveness in other pathologic bone conditions that are characterized by altered bone remodelling.

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“…Nell'ambito della famiglia dei bisfosfonati, la molecola che recentemente ha offerto le più convincenti dimostrazioni d'efficacia è rappresentata dal neridronato, somministrato per via endovenosa al dosaggio di 100 mg ogni tre giorni per 4 volte nell'arco di 10 giorni. A differenza dei trial precedenti con minor casistica, nello studio doppio cieco vs placebo di Varenna et al [23], studio che ha portato alla registrazione AIFA dell'indicazione, sono stati reclutati 82 pazienti affetti da CRPS-I alla mano o al piede secondo i criteri di Budapest, con una durata di malattia non superiore a 4 mesi e con documentata ipercaptazione scintigrafica. Entro i primi 20 giorni dall'inizio del trattamento, la VAS del dolore si è ridotta in entrambi i gruppi, ma maggiormente nel gruppo trattato con neridronato; successivamente si è osservata un'ulteriore riduzione del dolore solo nei pazienti che erano stati trattati con neridronato (Fig.…”

Section: Terapia Dell'algodistrofiaunclassified

La sindrome algodistrofica o Complex Regional Pain Syndrome type 1

2016

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COMPLEX REGIONAL PAIN SYNDROME TYPE 1 Complex regional pain syndrome (CRPS) includes a wide range of conditions affecting a peripheral limb characterised by chronic disabling pain that is seemingly disproportionate in time or degree to the usual course of any known trauma or other lesion. Pain is regional and it is typically associated with abnormal sensory, motor, sudomotor, vasomotor and/or trophic findings. The pathophysiology is still poorly understood. The disease shows a female preponderance with a peak age of incidence around the 5th and 6th decade. The available diagnostic criteria for CRPS-I rely exclusively on clinical criteria, that are unfortunately focused on the signs and symptoms of the chronic and late disease, while little emphasis is given to the typical imaging (X-rays, bone scintigraphy, MRI) findings of the early phase. Over the last decades, several therapies have been proposed but the few studies available are often too small to be conclusive and rarely evolved to randomised controlled trials (RCTs). On the basis of the results of a few RCTs, only bisphosphonate therapy appears to provide substantial benefits, especially in patients in the early phase of the disease, often leading to persistent remission or complete healing. In conclusion, short courses of high doses of bisphosphonates should be considered the treatment of choice for patients with CRPS-I. Introduzione e definizioneCon il termine di sindrome algodistrofica si definiscono quadri clinici caratterizzati da segni e sintomi molto eterogenei recentemente raggruppati nell'entità clinica denominata complex regional pain syndrome di tipo I (CRPS-I) [1]. Ad oggi i criteri diagnostici sono quelli di Budapest, pubblicati nel 2007 e riassunti in Tabella 1 [2]. La CRPS-I viene quindi definita come "un insieme di condizioni dolorose in assenza di un'interpretazione diagnostica alternativa caratterizzate da dolore continuo (spontaneo e/o evocato) che appare sproporzionato per estensione temporale o per intensità rispetto a quanto atteso sulla base del trauma o dell'evento scatenante. Il dolore ha distribuzione regionale e solitamente ha una localizzazione distale in associazione a segni e sintomi caratteristici di natura sensitiva, motoria, sudomotoria, vasomotoria e trofica" con evoluzione variabile nel tempo. Viene pertanto nettamente distinta rispetto al tipo II (sindrome causalgica) che è la conseguenza di un trauma diretto su un ramo nervoso. EpidemiologiaLa variabilità dei sintomi e delle classificazioni non consentono dati precisi sull'incidenza e prevalenza della malattia. Nella maggior parte dei casi il problema è scatenato da un trauma o da una frattura, in circa il 30% dei casi segue un intervento chirurgico (anche per via artroscopia) o eventi vascolari (infarti o ischemie cerebrali) mentre in una minoranza dei casi (circa 10%) non è riconoscibile alcun evento scatenante [3,4]. La patologia sembra più frequente nella quarta-sesta decade di vita con una maggior incidenza nel sesso femminile [4,5].

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Treatment of complex regional pain syndrome type I with neridronate: a randomized, double-blind, placebo-controlled study

Abstract: EU Clinical Trials Register, https://www.clinicaltrialsregister.eu/, 2007-003372-18.

Cited by 128 publications

References 22 publications

Guidelines for the diagnosis, prevention and management of osteoporosis

Guidelines for the diagnosis, prevention and management of osteoporosis

Neridronate: From Experimental Data to Clinical Use

La sindrome algodistrofica o Complex Regional Pain Syndrome type 1

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