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Editorial Response 7/17/08 4:28 PM Page 587 Publication
Editorial Opinion Versus Real Data and t
Knowledge of the Literature
The March/April 2008 issue of the International Jour- Merck Co, Whitehouse Station, NJ) and showed nal of Oral and Maxillofacial Implants (JOMI) printed the same correlation in their 1,999 patients.
an unusual editorial by Dr Sreenivas Koka of the Mayo Moreover, the randomized prospective double- Clinic. It was unusual in that it focused criticism on a blind study of zoledronic acid for the treatment single peer-reviewed article that was published not in of osteoporosis, given at 5 mg intravenously on a JOMI but in another journal altogether, was written once per year dosing (now marketed as Reclast, by a colleague of the JOMI editor, and was rushed to Novartis Pharmaceuticals, East Hanover, NJ), print: moreover, the authors of the targeted article and the insulted journal were given no opportunity Administration (FDA), used the same CTX to test to counter the editorial. By presenting his opinions in for “alendronate washout” when screening the form of an editorial rather than a letter to the edi- patients for their study. Like us, these investiga- tor, Dr Koka transparently attempts to escape the tors also noted the correlation between rising point/counterpoints format in order to air his faulty assertions. As the senior author of the criticized publi- • The editorial seeks to trivialize the CTX test as just cation, I take exception to this tactic and regard it as another “surrogate marker of bone turnover.” nothing more than a letter to the editor. Furthermore, Here again, Dr Koka betrays his ignorance with we offer the following facts to expose the “editorial” the medical literature. Rosen et al completed two as biased and naive about real data and the current extensive comparison studies of all standard bone turnover markers, including the serum andurine CTX and NTX as well as osteocalcin, alkaline • Readers of JOMI should realize Dr Koka’s phosphatase, hydroxyproline, and others. They hypocrisy. He recommends in his final paragraph reported that the serum CTX was the most accu- “the rigorous application of the scientific method rate, had the least day to day and diurnal varia- and proper scrutiny of the peer review process.” tion, and correlated best to a clinical situation.4,5 Very heady words indeed. However, he fails to My coauthors and I confirmed that the morning report that the article he criticizes contains real fasting serum CTX was more reliable than the data and was peer-reviewed prior to being pub- urine NTX, which was the previous standard for lished in the Journal of Oral and Maxillofacial assessing bone turnover suppression, and there- Surgery. As a prosthodontist, Dr Koka has no idea of that journal’s peer-review process. On the • The editorial criticizes what Dr Koka refers to as a other hand, an editorial is just that, a statement of “lack of objective measures.” What could be more opinion that may disagree with real data but that objective and measurable than exposed bone remains only opinion nevertheless. Dr Koka offers that fails to heal for 8 to 12 weeks and then heals no data of his own and has not submitted any to completely in a one to one correlation with a the peer-review process to which he claims to drug holiday and rising CTX values in every case (ie, 100% correlation)? My coauthors and I pub- • Dr Koka’s editorial takes issue with the morning lished 30 prospective cases of an uncommon fasting C-terminal telopeptide (CTX) test and its drug complication, oral bisphosphonate-induced correlation, apparently without any understand- osteonecrosis of the jaws (BIONJ), 3 of whom lost ing of the background of this test or familiarity at least one half of their mandible as a result of it, with the current medical literature. In addition to and correlated this complication directly with an our published data (and more to come) identify- over-suppression of bone turnover. We now have ing the usefulness and limitations of the serum seen 50 prospective cases with statistical validity, CTX test, Black et al2 used the very same CTX in correlating low CTX values with bone turnover their seminal 10-year multicenter randomized suppression. How many cases does Dr Koka need? prospective study of alendronate (Fosamax, The International Journal of Oral & Maxillofacial Implants COPYRIGHT 2007 BY QUINTESSENCE PUBLISHING CO, INC. PRINTING OF THIS DOCUMENT IS RESTRICTED TO PERSONAL USE ONLY. NO PART OF THIS ARTICLE MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM WITHOUT WRITTEN PERMISSION FROM THE PUBLISHER Editorial Response 7/17/08 4:28 PM Page 588 • In response to Dr Koka’s little saying that he Publication
admittedly took from “some humorous graffiti a few years back,” I would offer a more appropriate Marx RE, Cillo JE, Ulloa JJ. Oral bisphosphonate-induced quote from former President John F. Kennedy: osteonecrosis: risk factors, prediction of risk using serum CTX “and we shall let history be the final judge of our testing, prevention, and treatment. J Oral Maxillofac Surg ence
deeds.” Time, not editorial opinion, will deter- Black DM, Schwarz AV, Ensrud KE, et al. Flex Research Group: mine the true value of any test or treatment. Effects of continuing or stopping Alendronate after 5 years oftreatment. The fracture intervention trial long term extension The readers of JOMI should know that the very (FLEX). A randomized trial. JAMA 2006;296:2927–2938.
pathophysiology of osteoporosis, its treatment, and Black DM, et al. Once yearly zoledronic acid for treatment ofpostmenopausal osteoporosis. N Engl J Med 2007;356: the true value of all bisphosphonates is now coming under serious question not by editorial opinion but Rosen HN, Moses AC, Garber J, et al. Serum CTX. A new by peer-reviewed publications. First, over 4,000 cases marker of bone resorption that shows treatment effect more of bisphosphonate-induced osteonecrosis due to often than other markers because of low coefficient of vari- intravenous bisphosphonates have been reported to ability and large changes with bisphosphonate therapy. CalcifTissue Int 2000;60:100–108.
the FDA, and many more go unreported.7 Three very Rosen HN, Moses AC, Garber J, et al. Utility of biochemical recent independent peer-reviewed publications8–10 markers of bone turnover in the follow up of patients treated have concluded that oral bisphosphonates have a with bisphosphonates. Calcif Tissue Int 1998;63:363–370.
significantly less therapeutic benefit in the treatment Advisory Task Force on Bisphosphonate-Related Osteonecro- of osteoporosis in contrast to those originally pub- sis of the Jaws. American Association of Oral and MaxillofacialSurgeons: American Association of Oral and Maxillofacial Sur- lished by the drug company–sponsored studies. In geons Position Paper on Bisphosphonate Related addition, reports of spontaneous long bone fractures Osteonecrosis of the Jaws. J Oral Maxillofac Surg 2007;65: in patients taking alendronate for 10 years or more, consistent with the over-suppression of bone Edwards BJ, Gounder M, McKay JM, et al. Bisphosphonate use turnover we introduced and predicted by the CTX and osteonecrosis of the jaw: A review of the pharmocovigi-lance and reporting of serious adverse event. Lancet Oncol test, have also appeared in prestigious medical jour- nals such as the New England Journal of Medicine.11 Adami S, Isaia G, Luiselto G, Minisola S, Sinigalea L, et al.
Dr Koka is indeed correct in stating that the Osteoporosis treatment and fracture incidence: The ICARO “scientific dental literature is growing rapidly and longitudinal study. Osteoporos Int 2008, DOI 10.1107/ S presents a daunting challenge.” He unfortunately Teppo LNJ, Sievanen H, Khan KM, Heinonen A, Kannus P.
overlooks the scientific medical literature, which is Shifting the focus in fracture prevention from osteoporosis to also growing rapidly and poses its own daunting challenge. We dental practitioners must now become 10. Alonso-Coello P, Garcia Franco AL, Guyatt G, Ray M. Drugs for much more familiar with and knowledgeable about pre-osteoporosis: Prevention or disease mongering? BMJ bone science, bone homeostasis, bone turnover, and 11. Lenart BA, Lorich DC, Lane JM. Atypical fractures of the the disease of osteoporosis, not only as they relate to femoral diaphysis in postmenopausal women taking Alen- dental implants but also for our patients’ overall well- dronate. N Engl J Med 2008;358:1304–1305.
being. The serum CTX, the DXA/DEXA scan test forbone density, and MRI imaging for marrow spacechanges are all useful tools for bone assessment thatalready have shown clinical correlation and value forthose who choose to use them. Who, then, is really blind? Those who cannot see, or those who choose not to see? We now have an opportunity to work with our counterparts in medi-cine and to teach and learn from each other. The Dr Marx's comments are in response to an editorial in road there is not through editorials but through hard JOMI (Volume 23, Number 2, 2008) written by Sreenivas Koka, DDS, MS, PhD. Dr Koka is an Associate Editor of JOMIand has been in this position since 2005. Dr Koka's PhDresearch involved bone biology. He is a member of the American Society of Bone and Mineral Research Task Force on Osteonecrosis of the Jaw and his editorial was written as part of a long-standing policy of JOMI that Division of Oral and Maxillofacial Surgery requests one editorial from one Associate Editor each University of Miami Miller School of Medicine year. The editorial was submitted by Dr Koka on time to meet our editorial deadline; it was not rushed to press.

Source: http://jomi.quintessenz.de/jomi_2008_04_s0587.pdf


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