Demineralization removes residual alendronate in allograft bone procured from donors with a history of bisphosphonate use.

BACKGROUND: Bisphosphonate-associated osteonecrosis (BON) of the jaw is a growing concern in the dental community, but the possible presence of residual bisphosphonates in demineralized allograft bone from bisphosphonate-using tissue donors and the clinical implications of using such bone are unclear. The objectives of this study are to determine whether alendronate remained in demineralized bone matrix (DBM) procured from donors with a documented history of oral bisphosphonate use and to examine whether the demineralization process removes alendronate from allograft bone. METHODS: A gas chromatography?mass spectrometry method was developed and validated to quantify residual alendronate in allograft bone. Alendronate levels in DBM procured from tissue donors with a history of oral bisphosphonate use were compared to alendronate levels in DBM procured from donors without a history of bisphosphonate use. In addition, mineralized and demineralized bone was soaked in alendronate at concentrations of 0.002, 2.0, and 2,000 ng/mg bone and analyzed to examine the effect of the demineralization process. RESULTS: Residual alendronate was not detected in the DBM from either group, nor was it detected in any of the DBM samples soaked in alendronate solutions. Soaked mineralized bone contained measureable alendronate, but the substance was removed by demineralization. CONCLUSIONS: The demineralization process effectively removed residual alendronate from allograft bone. These results may relieve anxieties regarding the use of DBM in dental patients because it is unlikely to trigger BON of the jaw.

Transmission of hepatitis C virus to several organ and tissue recipients from an antibody-negative donor.

BACKGROUND: Although hepatitis C virus (HCV) transmission through tissue transplantation has been rarely reported, a donor with undetected viremia may infect several recipients. A patient developed acute hepatitis C shortly after tissue transplantation. Ninety-one tissues or organs had been recovered from the donor. OBJECTIVE: To determine whether the donor was the source of infection and the extent of transmission to other organ and tissue recipients. DESIGN: Descriptive epidemiologic study; serum testing for HCV infection. SETTING: Recipients were located in 16 states and 2 other countries. PARTICIPANTS: Donor and graft recipients. MEASUREMENTS: Hepatitis C virus infection was defined as the presence of anti-HCV or HCV RNA. The authors determined the genetic relatedness of viral isolates from the donor and recipients by genotype comparison and quasi-species analysis. RESULTS: The donor was anti-HCV-negative but was HCV RNA-positive (genotype 1a). Forty persons received transplants during 22 months. Five persons were HCV-infected before transplantation or had a genotype other than 1a, and 5 persons had no post-transplantation serum specimens available. Of the remaining 30 recipients, HCV infection occurred in 8 recipients: 3 of 3 organ recipients, 1 of 2 saphenous vein recipients, 1 of 3 tendon recipients, and 3 of 3 tendon with bone recipients. These 8 recipients had viral isolates genetically related to those of the donor. No cases occurred in recipients of skin (n = 2), cornea (n = 1), or irradiated bone (n = 16). LIMITATIONS: Post-transplantation serum specimens were unavailable for 5 recipients. CONCLUSIONS: An anti-HCV-negative donor was the source of HCV infection for 8 recipients of organs or tissues. Although HCV transmission from anti-HCV-negative donors is probably uncommon, changes in donor screening to include routine testing for HCV RNA merit further consideration to improve the safety of transplantation.