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
To compare serum levels of PTH, ALP, calcium, and phosphorus between cancer patients with and without denosumab-related MRONJ and evaluate their association with disease severity.
Design
A cross-sectional, comparative case-control study conducted on 70 patients (35 in the case group and 35 in the control group) using non-randomized convenience sampling, not blinded.
Settings and conduct
The study is conducted at the Oral and Maxillofacial Surgery Departments of Sina and Imam Khomeini Hospitals in Tehran. After clinical examination and staging of MRONJ (using AAOMS criteria and panoramic/CBCT imaging), 5 mL fasting venous blood samples are collected from patients between 8:00 and 10:00 AM. Serum levels of PTH (via ECLIA) and ALP, calcium, and phosphorus (via colorimetric/spectrophotometric methods) are measured in the hospital laboratory.
Participants/Inclusion and exclusion criteria
Inclusion: Cancer patients aged >=20; receiving denosumab >=1 year; MRONJ group (AAOMS criteria) vs control group (no MRONJ); informed consent. Exclusion: Head/neck radiation; metabolic bone diseases; maxillofacial surgery in past 3 months; oral infections.
Intervention groups
Case group: 35 cancer patients receiving denosumab who developed MRONJ.
Control group: 35 cancer patients receiving denosumab without any signs or symptoms of MRONJ, matched for demographic variables.
Main outcome variables
Serum levels of parathyroid hormone (PTH); serum levels of alkaline phosphatase (ALP); serum calcium (Ca) concentration; serum phosphorus (P) concentration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260530069570N1
Registration date:2026-10-20, 1405/07/28
Registration timing:prospective
Last update:2026-10-20, 1405/07/28
Update count:0
Registration date
2026-10-20, 1405/07/28
Registrant information
Name
Fatemeh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 225 7592
Email address
shadiabbasiiii19@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-11-06, 1405/08/15
Expected recruitment end date
2027-04-04, 1406/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of Bone Biomarkers in Denosumab-Induced Jaw Osteonecrosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Dentistry, Islamic Azad University of Medical Sciences, Tehran
Street address
No. 4, 10th Neyestan St., Pasdaran Ave., Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2026-05-20, 1405/02/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1405.022
Health conditions studied
1
Description of health condition studied
Medication-related osteonecrosis of the jaw (MRONJ)
ICD-10 code
M87.1
ICD-10 code description
Osteonecrosis due to drugs
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Diagnosis
2
Description
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.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Abbasi
Street address
Imam Khomeini Street, Hassan Abad Square, Sina Hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
0934045658@iau.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 4, 10th Neyestan St., Pasdaran Ave., Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
0934045658@iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Abbasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 12, Shavari Alley, Opposite Shariati Metro, Shariati St.
City
Tehran
Province
Tehran
Postal code
1948615311
Phone
+98 910 225 7592
Fax
Email
shadiabbasiiii19@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Asieh Rahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Medicine
Street address
No. 4, 10th Neyestan St., Pasdaran Ave., Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
0934045658@iau.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Abbasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 12, Shavari Alley, Opposite Shariati Metro, Shariati St.
City
Tehran
Province
Tehran
Postal code
1948615311
Phone
+98 910 225 7592
Fax
Email
shadiabbasiiii19@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect participants' confidentiality and privacy, individual participant data will not be shared publicly.