Clinical Research Directory

Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma

This is a randomized unblinded Phase II clinical trial evaluating the impact of intensive antihypertensive control (targeted to the 50-75th percentile for age, sex, and height) compared to conventional antihypertensive control (targeted to the 90-95th percentile for age, sex, and height) on the incidence of radiographically extensive osteonecrosis in children and young adults receiving treatment for newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL). Primary Objective * Compare the frequency of radiographically extensive osteonecrosis in patients receiving intensive compared to conventional antihypertensive therapy. Secondary Objectives * Evaluate the efficacy of intensive antihypertensive control compared to conventional antihypertensive control in the prevention of clinically significant (CTCAE Grade 2 or higher) and radiologically extensive osteonecrosis, overall and stratified by joints. * Compare the frequency of clinically significant and radiographically extensive osteonecrosis in patients receiving antihypertensive therapy and historical controls. * Compare blood pressures achieved in intensive and conventional arms using both pressures obtained as part of routine patient care and ambulatory blood pressure monitoring. * Compare levels of vascular dysfunction as measured physiologically, radiographically, and in blood samples in patients receiving intensive compared to standard antihypertensive therapy. Exploratory Objectives * Identify predictive patterns of blood biomarkers which identify patients at high- risk of developing clinically significant osteonecrosis. * Identify MRI findings during late induction which correlate with osteonecrosis lesions seen during reinduction. * Identify patterns of diurnal blood pressure variation as measured by ambulatory blood pressure monitoring associated with the later development of osteonecrosis. * Compare induction blood pressure control and intervention arm to echocardiographic changes at reinduction II. * Evaluate patient-reported, health-related quality of life in patients during induction and after 1.5 years of therapy when many experience the symptoms of osteonecrosis.

Piezoeletric Surgery vs Conventional Surgery for Treatment of MRONJ

To date, surgical therapy of MRONJ remains the therapy of choice while still in association with a medical approach. Surgical intervention aims to stop the progression of the pathology through the removal of the tissue macroscopically affected (resective surgery,sequestrectomy, debridement). These surgical procedures are classically performed by the use of handpiece burs, but due to the advent of piezoelectric surgery in dentistry, a comparison of the two techniques is required At present there are no randomized clinical trials designed to compare the postoperative discomfort of the two previously described techniques in the treatment of MRONJ. Therefore, the aim of this study is to evaluate the postoperative discomfort in a group of patients undergoing surgical therapy for MRONJ with piezoelectric instruments compared to a control group undergoing MRONJ surgical therapy with traditional rotary instruments. METHODS This is a randomized clinical trial conducted in patients diagnosed with MRONJ who require surgical therapy. Patients will be recruited and evaluated for a period of 24 months. Follow-up of patients enrolled in the study will last 12 months. Specifically, once patients diagnosed with MRONJ requiring surgical therapy are identified, surgery will be scheduled within 1 month, then follow-up visits will be conducted at 1, 2, 3 weeks and 3, 6, 12 months after surgery. Patients enrolled and randomized into one of the two groups will all undergo necrotic bone removal surgery by the same operator with decades of experience in treating MRONJs. Marginal bone resection surgery will be performed using rotary or piezoelectric instruments. Both surgical procedures involve wound closure by first intention healing using sutures. Each bone block removed will undergo histologic examination for diagnostic confirmation of osteonecrosis. Postoperative instructions will be explained to patients, and sutures will be removed at 7 or 14 days after surgery. Each patient will be asked for a 3D radiologic exam (CT or CBCT) at least 12 months after surgery in order to asses the

Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs

The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.