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IRCT20260530069570N1 IRCT 2026-10-20 Islamic Azad University Evaluation of Bone Biomarkers in Denosumab-Induced Jaw Osteonecrosis Comparison of Serum Levels of PTH, ALP, Calcium, and Phosphorus in Cancer Patients with and without Medication-Related Osteonecrosis of the Jaw (MRONJ) Receiving Denosumab 2026-11-06 anticipated 70 Recruiting https://irct.ir/trial/93190 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This observational case-control study evaluates serum levels of PTH, ALP, calcium, and phosphorus in 70 cancer patients treated with Denosumab (35 patients with MRONJ and 35 matched controls without MRONJ) to assess potential diagnostic and prognostic bone turnover biomarkers. N/A Medication-related osteonecrosis of the jaw (MRONJ). Intervention 1: Intervention group: 35 cancer patients receiving Denosumab (Xgeva) who developed medication-related osteonecrosis of the jaw (MRONJ) according to AAOMS 2020 criteria. Fasting venous blood samples (5 mL) are collected to measure serum levels of PTH, ALP, calcium, and phosphorus. Intervention 2: Control group: 35 cancer patients receiving Denosumab (Xgeva) without any clinical or radiographic evidence of MRONJ, matched for age and sex. Fasting venous blood samples (5 mL) are collected to evaluate serum levels of PTH, ALP, calcium, and phosphorus. No - There is not a plan to make this available Justification or reason for not sharing IPD is To protect participants' confidentiality and privacy, individual participant data will not be shared publicly.
public Fatemeh Abbasi
No. 12, Shavari Alley, Opposite Shariati Metro, Shariati St.
Tehran Iran (Islamic Republic of) 1948615311 +98 910 225 7592 shadiabbasiiii19@gmail.com Islamic Azad University scientific Asieh Rahimi
No. 4, 10th Neyestan St., Pasdaran Ave., Faculty of Dentistry
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 0934045658@iau.ir Islamic Azad University Iran (Islamic Republic of) Cancer patients aged 20 years or older History of receiving high-dose Denosumab (Xgeva) for at least one year Patients diagnosed with MRONJ according to AAOMS 2020 criteria for the case group Patients receiving Denosumab without any clinical or radiographic evidence of MRONJ for the control group Willingness to participate and signing the written informed consent 20 years no limit Both History of radiation therapy to the head, neck, or maxillofacial region History of metabolic bone diseases unrelated to MRONJ History of maxillofacial surgery within the past 3 months Presence of active and acute oral or dental infections unrelated to MRONJ Refusal to continue participation at any stage of sampling M87.1 Osteonecrosis due to drugs Diagnosis Diagnosis Intervention group: 35 cancer patients receiving Denosumab (Xgeva) who developed medication-related osteonecrosis of the jaw (MRONJ) according to AAOMS 2020 criteria. Fasting venous blood samples (5 mL) are collected to measure serum levels of PTH, ALP, calcium, and phosphorus. Control group: 35 cancer patients receiving Denosumab (Xgeva) without any clinical or radiographic evidence of MRONJ, matched for age and sex. Fasting venous blood samples (5 mL) are collected to evaluate serum levels of PTH, ALP, calcium, and phosphorus. Serum alkaline phosphatase (ALP) activity level. Timepoint: At the time of patient enrollment following diagnosis and prior to any intervention. Method of measurement: Enzymatic colorimetric / photometric method according to IFCC protocol using Hitachi 902 autoanalyzer. Serum intact parathyroid hormone (PTH) level. Timepoint: At the time of patient enrollment following diagnosis and prior to any intervention. Method of measurement: Chemiluminescence / electrochemiluminescence immunoassay (ECLIA) using Stat Fax 2600 analyzer. Serum calcium (Ca) and phosphorus (P) concentrations. Timepoint: At the time of patient enrollment following diagnosis and prior to any intervention. Method of measurement: Colorimetric enzymatic method (Arsenazo III/o-CPC) for calcium and photometric colorimetric method (Phosphomolybdate/UV) for phosphorus using BT-3500 biochemistry analyzer. Islamic Azad University Approved 2026-05-20 Ethics Committee of Faculty of Dentistry, Islamic Azad University of Medical Sciences, Tehran No. 4, 10th Neyestan St., Pasdaran Ave., Faculty of Dentistry Tehran Tehran Iran (Islamic Republic of)