Journal
ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY
Volume 115, Issue 2, Pages 224-232Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.oooo.2012.08.455
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Funding
- NIH/NCRR SC-CTSI Grant [UL1 RR031986]
- NIH/NIMHD
- NIH-NIGMS [R01 GM068968]
- NIH-NICHD [R01 HD070996]
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Objective. We hypothesized that patients with bisphosphonate (BP)-related osteonecrosis of the jaw (BRONJ) accumulate higher levels of BP in bone than those without BRONJ. Study Design. Using the Pmetrics package and published data, we designed a population pharmacokinetic model of pamidronate concentration in plasma and bone and derived a toxic bone BP threshold of 0.2 mmol/L. With the model, and using patient individual BP duration and bone mineral content estimated from lean body weight, we calculated bone BP levels in 153 subjects. Results. Mean bone BP in 69 BRONJ cases was higher than in 84 controls (0.20 vs 0.10 mmol/L, P < 0.001), consistent with the toxic bone threshold of 0.2 mmol/L. BRONJ was also associated with longer duration BP therapy (5.3 vs 2.7 years, P < 0.001), older age (76 vs 70 years, P < 0.001), and Asian race (49% vs 14%, P < 0.001). Conclusions. Our model accurately discriminated BRONJ cases from controls among patients on BP therapy. (Oral Surg Oral Med Oral Pathol Oral Radiol 2013;115:224-232)
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