CTX Biochemical Marker of Bone Metabolism. Is It a Reliable Predictor of Bisphosphonate-Associated Osteonecrosis of the Jaws After Surgery? Part II: A Prospective Clinical Study

Abstract

Biochemical markers of bone metabolism have been used in medicine to evaluate and provide treatment to patients with metabolic bone diseases, such as osteoporosis. Serum cross-linked C-telopeptide of type I collagen (CTX) is a marker of osteoclast activity and is used to assess the level of bone resorption. Recently, in oral and maxillofacial surgery, it was proposed that the levels of serum CTX may predict the subsequent risk of developing osteonecrosis of the jaws (ONJ) after oral surgery procedures for patients taking oral bisphosphonates (BPs). The goal of this study was to determine whether this specific serum marker of bone resorption could preoperatively predict the risk of developing ONJ from oral BPs.We hypothesized that there is no clinical correlation between the observed preoperative serum CTX values and the risk of developing ONJ. The authors examine the scientific basis (validity) of the morning fasting serum CTX test in 163 consecutive patients who underwent various oral surgery procedures in the office. The authors also review the laboratory test results and the recommended protocol based on the test values. One hundred sixty-three patients (mean age, 75.9 years) were divided into 2 groups. Group I was the control group that consisted of 109 patients taking oral BPs who did not take the CTX test preoperatively. Group 2 consisted of 54 patients taking BPs and who elected to have the CTX test performed to assess their level of risk of developing ONJ, preoperatively. Both groups of patients were observed for a period of 8 weeks for signs and symptoms of BP-associated ONJ after surgery. The clinical data at 8 weeks and beyond revealed that there was no evidence of BP-associated ONJ in all participants. We conclude that the serum CTX is not a valid preoperative test to accurately assess the level of risk of developing ONJ and is not indicated in the oral surgery patient.

Biochemical markers of bone turnover in osteonecrosis of the jaw in patients with osteoporosis and advanced cancer involving the bone

“…Thus, this analysis reported no association between low serum CTX levels (100 pg/mL) and ONJ in osteoporosis 27,28 . A recent small, prospective study investigated the potential role of serum CTX monitoring to assess the risk for ONJ in osteoporosis patients on oral BPs undergoing oral surgery 29 . A control group that consisted of n = 109 patients taking oral BPs did not take the CTX test preoperatively.…”

“…Recently, data from four studies of zoledronic acid, including the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial in postmenopausal women, a recurrent fracture prevention study in patients with previous hip fracture, a glucocorticoid‐induced osteoporosis study, and a male osteoporosis study, were pooled, and serum CTX data from n = 11,000 patients were examined 27,28 . Only two cases of adjudicated ONJ (one in a placebo patient and one in a zoledronic acid‐treated patient) were reported and have been previously described 27–29 . The serum CTX levels of the placebo patient diagnosed with ONJ were >260 pg/mL.…”

İlaçlara Bağli Çene Kemi̇ği̇ Osteonekrozu: Derleme

“…İlaca ara verilmesinin İÇKON insidansını değiştirdiği konusunda bilimsel bir kanıt bulunmamaktadır. ADA bilimsel kurulu 2011 yılında BPs'lerin düşük birikim dozunda (2 yıldan az kullanım) ve denosumab kullanan hastalarda ilaca ara verilmesine gerek olmadığını bildirmektedir 74 . Bununla birlikte ilaca ara verilmesinin, yüksek birikim dozuna maruz kalan hastalarda (4 yıldan uzun süreli kullanım) ve romatoid artrit, önceden veya halen devam eden kortikosteroid tedavisi, diabetus mellitus ve yara iyileşmesi tamamlanana kadar olan sürede sigara kullanımı gibi eşlik eden durumlarda yararlı olduğu da bildirilmektedir.…”

The Facial Skeleton in Patients with Osteoporosis: A Field for Disease Signs and Treatment Complications

“…An expert panel recommended that using this test may not be an evidence-based approach as a control group was missing in the initial study [99]. Other authors also commented on the lack of quality evidence with regard to the predictive value of CTX [100] while a study with limited followup concluded that serum CTX is not a valid preoperative test to accurately assess the level of risk of developing ONJ and is not indicated in the oral surgery patient [101]. Because ONJ can be a devastating complication of bisphosphonate therapy, a collaborative effort between dentists and physicians in deciding on the patient's dental treatment is recommended, because it can minimize complications and adverse events.…”