Dental Practitioners’ Knowledge and Attitudes on Bisphosphonate Related Osteonecrosis of the Jaw (BONJ) James S. Bone, MS, DDS, FICD, MAGD South Texas Oral Health Network The University of Texas Health Science Center San Antonio
Why Study BONJ?
Fear Confusion Uncertainty Risk Panic Warning Litigation
How much do we need to know? F ear = Neglect Jump into unknown = Trouble
1 st Generation – oral bisphosphonates Introduced in 1990’s Improve bone quality in Pagets Disease Osteoporosis Alternative to HRT in post menopause women Prevent fractures of spine, wrist and hip 2ndry to corticosteroid use, SLE, RA, Injectables introduced for pts with dosing difficulties, inability to sit upright for 60 mins or swallow tablets
2 nd and 3 rd Generation – IV bisphosphonates Hypercalcemia of malignancy Prevent metastatic tumors in breast, lung and prostate cancer Prevent bone complications and pain in multiple myeloma and kidney disease Prevent post-operative fractures and weakness in kidney, liver and cardiac transplant patients
Wonder Drug? 19 th most prescribed drug group worldwide Synthetic analogues of pyrophosphates Not metabolized ½ absorbed dose is distributed to bone Increase bone density and thickness Prevent tumors from removing bone and spreading Inhibit differentiation of bone marrow cells into osteoclasts Inhibit osteoclast activity Reduction in bone turnover and resorption Reduce local release of factors that stimulate tumor growth
Side effects Osteoclast function severely impaired Osteocytes not replaced Capillary network in bone not maintained Bone becomes too dense, choking capillary network Avascular bone necrosis Osteonecrosis
Incidence of BONJ in Maxilla and Mandible 3000 world cases (191 million prescriptions) Mostly associated with intravenous (IV) bisphosphonates Zometa (Zoledronic Acid) Aredia (Palmidronate) Mostly following dental extractions or periodontal surgery Some spontaneously Chronic infection Trauma
Facts IV Bisphosphonate = higher risk for BONJ 50% of dose is bio available for bone matrix Oral bisphosphonate = low risk for BONJ 1% of dose is absorbed by GI Tract Time Half life is 8-10 years
Risk Assesment? Recent assessment test for necrosis potential Arun Garg/Marx - Miami C-Terminal Telopeptide (CTX) -– marker for serum bone turnover scores – controversial
Why a dental problem? Bis Ph. accumulate in high turnover areas Higher concentrations of drug in mandible than elsewhere After trauma or infection bone cannot respond adequately Masticatory Forces Chronic Low Grade Trauma Unable to repair micro-fractures Necrotic Bone Bony sequestrum
What’s Been Studied • Only reported cases • Worst cases in IV………. • How many are related to “Oral” doses • What’s risk for “Oral” doses – Time dependant? – Dose dependant? – Drug dependant? • Treatment
STOHN BONJ Study • “Oral” route most commonly seen in our practices • What are practitioners doing when encountered? – Basic Treatment – Referral?? • Baseline education level – Is literature doing its job? – Altered treatment plans?
BONJ Study Development Formulated the question Gathered current literature Formulated hypothesis Developed study plan and parameters Developed survey Decided who to survey Gained IRB approval Survey Data collection and statistics
Relative Potency • Etidronate (Didronel) 1 • Tiludronate (Skelide) 10 • Pamidronate (Aredia) 100 • Alendronate (Fosamax) 1,000 • Risedronate (Actonel) 10,000 • Ibandronate (Boniva) 10,000 • Zolendronic acid (Zometa) >100,000
Development of the STOHN Research Protocol • Member suggested topics • Members voted for their top 4 topics • Issues related to patients taking bisphosphonate
1356-129 Literature Review • Determine what is already known • Determine what we should investigate • Few studies to date – A limited study on dentists’ and students’ knowledge performed in Murcia, Spain
Development of Subcommittee • STOHN staff, STOHN members, and UTHSCSA Faculty • Committee evaluated several drafts of the research proposal and survey
Initiate Study • 38 question online study developed • UTHSCSA Institutional Review Board approval • Survey sent out to STOHN members, local dentists members of the San Antonio District Dental Society, and UTHSCSA Faculty • Data collected through April 2011 • Department of Epidemiology and Biostatistics analyzed data
Study Aims • Aim 1: To assess practicing dentists’ perceptions, attitudes and knowledge toward BONJ and treatment recommendations regarding the management of patients with a history of bisphosphonate therapy. • Aim 2: To conduct a retrospective chart review to determine the associations between (1) the accuracy of practitioners’ perceptions about the prevalence of bisphosphonate use and BONJ in their practice, (2) practioners’ attitudes and knowledge, and (3) the treatment recommendations provided. • Aim 3: Develop educational materials to clarify misunderstandings identified in Aim 1 & 2, and evaluate their potential to lessen misperceptions of BONJ risks and prevalence.
Data Collected and Analyzed • Answer to questions directly • Associations between the questions evaluated – Expanded data – Collapsed data – Removal of specialist
Patients Taking Oral Bisphosphonates 1. Percent of patients taking or have taken ORAL bisphosphonates 0-3% 14 (18.2) 4-6% 22 (28.6) 7-9% 13 (16.9) 10-15% 14 (18.2) 15-20% 7 (9.1) >20% 7 (9.1) Total 77 • Nearly ½ (46.8%)of the dental practitioners report having less that 6% of their patients on oral bisphosphonates
Patients Taking IV Bisphosphonates 2. Percent of patients taking or have taken INTRAVENOUS bisphosphonates <1% 52 (66.7) 1-2% 21 (26.9) 3-4% 3 (3.8) 5-6% 1 (1.3) >8% 1 (1.3) Total 78 • Few practitioners report having more than 2% of patients taking IV bisphosphonates (6.4%)
BONJ Cases Encountered 3. Number BONJ cases encountered in my practice 0 38 (49.4) 1-5 32 (41.6) 6-10 4 (5.2) 10-15% 3 (3.9) Total 77 • However, about ½ of the practitioners have seen a BONJ case in their practice
Talk To Patients about BONJ 5. If one of my patients is taking bisphosphonates, I discuss the risk of n (%) BONJ Always 54 (69.2) Sometimes 19 (24.4) Rarely 4 (5.1) Never 1 (1.3) Total 78 • Most dentists talk to their patients about the risk of BONJ
Have Seen A BONJ Case Has the dental practitioner seen a BONJ case? Yes No Total P-value Dental Specialty, n 0.24 (%) General Dentistry 27 (58.7) 31 (70.5) 58 (64.4) All Specialties 19 (41.3) 13 (29.5) 32 (35.6) Total 46 44 90 • Almost ½ of the general dentists • Almost 2/3 of the specialists • BONJ may be more prevalent than we initially anticipated
Specific Informed-Consent 21. I have a specific informed-consent form for bisphosphonate-using patients True 27 (34.6) False 50 (64.1) Don't Know 1 (1.3) Total 78 Approximately 1/3 of dentists have a specific consent form for BONJ
Confident Managing BONJ Case 16. I feel confident that I could manage a case of BONJ Strongly Agree 7 (9.1) Agree 12 (15.6) Neutral 16 (20.8) Disagree 26 (33.8) Strongly Disagree 16 (20.8) Total 77 • 24.7% Strongly Agree/Agree • 54.6% Disagree/Strongly Disagree
Consent Form vs. Confidence I have a specific informed-consent form for bisphosphonate-using patients False/ P- True Don’t Total value Know 0.004 I feel confident Strongly Agree 7 (25.9) 0 (0) 7 (9.1) that I could manage Agree 5 (18.5) 7 (14) 12 (15.6) a case of BONJ, n (%) Neutral 5 (18.5) 11 (22) 16 (20.8) Disagree 6 (22.2) 20 (40) 26 (33.8) Strongly Disagree 4 (14.8) 12 (24) 16 (20.8) Total 27 50 77
Specific Informed-Consent Form for Patients Using Bisphosphonates • No consent (63.8%) > Consent (42.4%) – Do not feel comfortable managing a case of BONJ • Consent (39.4%) > No Consent (13.8%) – Felt confident managing a case of BONJ – When OMS removed 39.4% dropped to 28.6% • Perhaps having or not having specific consent is associated with confidence level in managing a case of BONJ – If going to treat = having a consent – If not treating = no need for consent
Patients Delay Bisphosphonate Therapy 23. Some of my patients elect to delay bisphosphonate therapy until dental treatment is completed True 25 (32.1) False 30 (38.5) Don't Know 23 (29.5) Total 78 Approximately 1/3 of the patients delay bisphosphonate therapy until dental treatment is completed
BONJ Cases Encountered 3. Number BONJ cases encountered in my practice 0 38 (49.4) 1-5 32 (41.6) 6-10 4 (5.2) 10-15% 3 (3.9) Total 77
Delay of Bisphosphonates vs Cases Encountered Some of my patients elect to delay bisphosphonate therapy until after dental treatment False/ True Don’t Know Total P-value 0.07 Number of BONJ 0 9 (36) 29 (56.9) 38 (50) cases encountered 1-5 15 (60) 16 (31.4) 31 (40.8) in my practice, n (%) 6-10 0 (0) 4 (7.8) 4 (5.3) >10 1 (4) 2 (3.9) 3 (3.9) Total 25 51 76
Patients Delay/Avoid Bisphosphonate Therapy Until Dental Tx is Completed • DDS has not seen a case of BONJ = 58.6% patients do NOT delay bisphosphonate tx • DDS that has seen 1-5 cases BONJ = 62.5% patients DO elect to delay bisphosphonate tx
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