The "CROMa" Project: A Care Pathway for Clinical Management of Patients with Bisphosphonate Exposure.

Mauro Capocci,Isabella Bignozzi,Livia Ottolenghi,Fabio Cocco,Umberto Romeo,Susanna Annibali

doi:10.1155/2014/719478

Mauro Capocci, Isabella Bignozzi + Show 4 more

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https://doi.org/10.1155/2014/719478

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Abstract

Aim. To describe 7 years of activity of “CROMa” (Coordination of Research on Osteonecrosis of the Jaws) project of “Sapienza” University of Rome. Materials and Methods. A preventive and therapeutic care pathway was created for patients with bisphosphonates (BPs) exposure. Demographic, social, behavioural, pharmacological, and clinical variables were registered in a dedicated database. Results. In the project, 502 patients, 403 females and 99 males, were observed. Bone pathologies were 79% osteometabolic diseases (OMD) and 21% metastatic cancer (CA). Females were 90% in OMD group and 41% in CA. BP administration was 54% oral, 31% IV, and 11% IM; 89% of BPs were amino-BP and 11% non-amino-BP. Consistently with bone pathology (OMD/CA), alendronate appears to be prevalent for OMD (40% relative), while zoledronate was indicated in 92% of CA patients. Out of 502 cases collected, 28 BRONJ were detected: 17 of them were related to IV BP treatment. Preventive oral assessment was required for 50% of CA patients and by 4% of OMD patients. Conclusions. The proposed care pathway protocols for BP exposed patients appeared to be useful to meet treatment and preventive needs, in both oncological and osteometabolic diseases patients. Patients' and physicians' prevention awareness can be the starting point of a multilevel prevention system.

Highlights

An osteonecrosis of the jaws (BRONJ) has been characterized as a main side effect of bisphosphonates (BPs) therapy [1, 2].This adverse event, first described by Marx and Stern in 2002 [3], has been characterized as nonhealing exposed bone in the mandible or maxilla [4,5,6,7] or currently defined as an area of exposed bone in the maxillofacial region that has persisted for more than 8 weeks in a patient on previous or current treatment with a bisphosphonate and without history of radiation therapy to the jaws
The active principles administered have seen in the whole group a prevalence of amino-BP drugs (89%), including alendronate (33% tot.), zoledronic acid (21% tot.), risedronate (17% tot.), neridronate (12% tot.), and ibandronate (6% tot.), compared to non-amino-BP administration (11%) represented only by clodronate
The distribution according to bone diseases (OMD/CA) has seen alendronate as a drug of choice for osteometabolic diseases (OMD) (40% rel.) followed by risedronate (21% rel.), while, in the other category, zoledronic acid was indicated in 92% of patients with metastatic bone cancer

Summary

Introduction

An osteonecrosis of the jaws (BRONJ) has been characterized as a main side effect of bisphosphonates (BPs) therapy [1, 2] This adverse event, first described by Marx and Stern in 2002 [3], has been characterized as nonhealing exposed bone in the mandible or maxilla [4,5,6,7] or currently defined as an area of exposed bone in the maxillofacial region that has persisted for more than 8 weeks in a patient on previous or current treatment with a bisphosphonate and without history of radiation therapy to the jaws. BRONJ condition may progress to severe forms with intractable pain, inability to eat, severe maxillary sinusitis, oroantral fistula, orbital abscess, extraoral fistula, involvement of the lower margin, and fracture of the mandible, especially when it affects debilitated patients [13, 14]

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