Five-year follow-up of Japanese patients with Paget's disease of the bone after treatment with low-dose oral alendronate: a case series

<p>Abstract</p> <p>Introduction</p> <p>Paget's disease of the bone is characterized by focal abnormalities of increased bone turnover affecting one or more sites throughout the skeleton. Although this disease is rare in Japan, it is common in western and southern Europe, and among British migrants in Australia and New Zealand. Bisphosphonates have been widely used for the treatment of Paget's disease of the bone and are considered to be the treatment of choice. However, there have been few reports on the long-term follow-up examination of patients after their treatment with bisphosphonates.</p> <p>Case presentation</p> <p>We report the treatment with a low dose of oral alendronate (5 mg per day) which was effective in reducing bone turnover and pain over the five-year follow-up period in two Japanese patients, a 66-year-old man and a 68-year-old woman, with Paget's disease of the bone. Furthermore, in one patient, no clinical symptoms, such as bone pain or increases in serum total alkaline phosphatase and urinary N-terminal telopeptide of type I collagen as markers of bone turnover, were observed over the patient's five-year follow-up period.</p> <p>Conclusions</p> <p>To the best of our knowledge, this is the first report of a long-term follow-up of patients with Paget's disease of the bone after a six-month treatment with low-dose oral alendronate (5 mg per day).</p

Is bisphosphonate therapy for benign bone disease associated with impaired dental healing? A case-controlled study

<p>Abstract</p> <p>Background</p> <p>Bisphosphonates are common first line medications used for the management of benign bone disease. One of the most devastating complications associated with bisphosphonate use is osteonecrosis of the jaws which may be related to duration of exposure and hence cumulative dose, dental interventions, medical co-morbidities or in some circumstances with no identifiable aggravating factor. While jaw osteonecrosis is a devastating outcome which is currently difficult to manage, various forms of delayed dental healing may be a less dramatic and, therefore, poorly-recognised complications of bisphosphonate use for the treatment of osteoporosis. It is hypothesised that long-term (more than 1 year's duration) bisphosphonate use for the treatment of post-menopausal osteoporosis or other benign bone disease is associated with impaired dental healing.</p> <p>Methods/Design</p> <p>A case-control study has been chosen to test the hypothesis as the outcome event rate is likely to be very low. A total of 54 cases will be recruited into the study following review of all dental files from oral and maxillofacial surgeons and special needs dentists in Victoria where potential cases of delayed dental healing will be identified. Potential cases will be presented to an independent case adjudication panel to determine if they are definitive delayed dental healing cases. Two hundred and fifteen controls (1:4 cases:controls), matched for age and visit window period, will be selected from those who have attended local community based referring dental practices. The primary outcome will be the incidence of delayed dental healing that occurs either spontaneously or following dental treatment such as extractions, implant placement, or denture use.</p> <p>Discussion</p> <p>This study is the largest case-controlled study assessing the link between bisphosphonate use and delayed dental healing in Australia. It will provide invaluable data on the potential link between bisphosphonate use and osteonecrosis of the jaws.</p

Nature and frequency of bisphosphonate-associated osteonecrosis of the jaws in Australia

Copyright © 2007 American Association of Oral and Maxillofacial Surgeons Published by Elsevier Inc.PurposeThe purpose of this study is to estimate the frequency and describe the clinical characteristics of patients diagnosed with bisphosphonate-associated osteonecrosis of the jaws (ONJ) in Australia.Materials and methodsCases of ONJ were identified in 2004 and 2005 primarily by a postal survey of Australian Oral and Maxillofacial Surgeons (OMS) with additional cases from other dental specialists and the Commonwealth of Australia Adverse Drug Reaction Committee (ADRAC). The clinical characteristics were recorded. The frequency of ONJ cases was estimated from prescription and dental extraction data. Univariate and bivariate statistics were calculated.ResultsOne hundred fifty-eight cases of ONJ were identified. These were primarily in patients with bone malignancy (72%) and the main trigger was dental extraction (73%). The reported number of cases varied between different Australian States with the highest frequency being reported in the States with the best integrated health systems. The frequency of ONJ in osteoporotic patients, mainly on weekly oral alendronate was 1 in 2,260 to 8,470 (0.01% to 0.04%) patients. If extractions were carried out, the calculated frequency was 1 in 296 to 1,130 cases (0.09% to 0.34%). The total dose of oral alendronate at the onset of ONJ was 9,060 (+/-7,269) mg. The frequency of ONJ for Paget's disease cases was 1 in 56 to 380 (0.26% to 1.8%). If extractions were carried out, the calculated frequency of ONJ was 1 in 7.4 to 48 (2.1% to 13.5%). The frequency of ONJ in bone malignancy cases, treated with mainly intravenous zoledronate or pamidronate was 1 in 87 to 114 (0.88% to 1.15%). If extractions were carried out, the calculated frequency of ONJ was 1 in 11 to 15 (6.67% to 9.1%) The total dose of pamidronate was 3,285 (+/-2,530) mg and zoledronate 62 (+/-54.28) mg at the onset of ONJ. The median time to onset of ONJ was 12 months for zoledronate, 24 months for pamidronate, and 24 months alendronate.ConclusionsBefore the prescription of bisphosphonates for bone disease the patient should be made dentally fit so that the need for subsequent dental extractions is minimized. Appropriate informed consent for the risk of ONJ for different bisphosphonates, for osteoporosis, and malignancy both in general and in particular for dental extractions can be provided using this data.Tony Mavrokokki, Andrew Cheng, Brien Stein and Alastair Gosshttp://www.elsevier.com/wps/find/journaldescription.cws_home/623146/description#descriptio