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Medication-Related Osteonecrosis of JawNCT06430762

Therapeutic Exposures and Risk Factors in MRONJ

An observational study of Medication-Related Osteonecrosis of Jaw, run by Marmara University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study focuses on patients who have developed a condition called medication-related osteonecrosis of the jaw (MRONJ), which can occur after using certain medications. The purpose is to closely monitor these patients over time to better understand how they are diagnosed, treated, and followed up. Read more about this study

Who is it for?
Ages 18 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Medication-Related Osteonecrosis of Jaw
How many people
250 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Apr 2024to 26 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population for this research comprises individuals aged 18 and over, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. The study excludes individuals with non-drug-related osteonecrosis or osteomyelitis, osteoradionecrosis, those with metastasis to the oral region, individuals who have not provided consent, and those under the age of 18.

Who may be able to join

  • Individuals aged 18 and over
  • Male or female individuals
  • Individuals who apply to the Marmara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery due to medication-related osteonecrosis of jaw during the study period
  • Individuals or their legal representatives who have given written consent to participate in the study

Who cannot join

  • Non-drug-related osteonecrosis/osteomyelitis
  • Osteoradionecrosis
  • Metastasis to the oral region
  • Individuals who have not given written consent to participate in the study
  • Individuals under the age of 18

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ferit Bayram, PhD contact

00902167775000

ferit.bayram@marmara.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Marmara University School of Dentistry

    Istanbul, 34854

    Ferit Bayram, Ph. D., 2167775074, ferit.bayram@marmara.edu.tr

    Ahmet Akıcı, Prof. Dr.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Identification of Therapeutic Exposures and Risk Factors Associated With Medication-Related Osteonecrosis of the Jaw

This study focuses on patients who have developed a condition called medication-related osteonecrosis of the jaw (MRONJ), which can occur after using certain medications. The purpose is to closely monitor these patients over time to better understand how they are diagnosed, treated, and followed up. By doing this, researchers hope to uncover how different factors such as a patient's background, lifestyle, and other health conditions might influence their recovery and overall quality of life.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Karnofsky Performance Status

    This outcome measures the overall health status and activity levels of patients with MRONJ using the Karnofsky Performance Scale (KPS). KPS rates patients on a scale from 0 to 100, where higher scores indicate greater independence and lower morbidity risk, while lower scores reflect dependency and the need for substantial medical intervention. The scale's aim is to quantify the extent to which patients can perform everyday life activities without assistance. At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken.

    Measured: 24 months

  2. Change in Oral Health-related Quality of Life

    A scale of 1 to 5 will be used to rate each of the 14 questions about how dental health affects quality of life (minimum score of 0, maximum score of 70). Higher ratings reflect a greater influence of the patient's dental health on their quality of life (higher scores, worse outcomes). At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken.

    Measured: 24 months

  3. Change in staging of MRONJ

    Staging of the lesion in the mouth will be according to the definition of the American Association of Oral and Maxillofacial Surgeons (Ruggiero et al. 2022). Clinical examination will be performed at baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if necessary).

    Measured: 24 months

  4. Biochemical Markers Related to Bone Metabolism and Inflammatory Response

    Various biochemical markers indicative of bone metabolism and inflammatory response in patients with medication-related osteonecrosis of the jaw (MRONJ) will be evaluated. The markers include serum calcium, ionized calcium, parathyroid hormone (PTH), alkaline phosphatase, osteocalcin, C-telopeptide (CTX), Vitamin D3, C-reactive protein (CRP), and leukocyte count. Blood samples collected at baseline will be analyzed.

    Measured: Baseline

  5. Change in the Assessment of Radiographic Changes Using the Composite Radiographic Index

    This outcome involves utilizing the Composite Radiographic Index to track and characterize the progression of lesions in patients with medication-related osteonecrosis of the jaw. This index evaluates:

    • Location of the lesion: Maxilla anterior, Maxilla posterior, Mandible anterior, Mandibular posterior.
    • Lyric changes: Scored as 0 (None), 1 (Localized), 2 (Widespread).
    • Sclerosis: Scored as 0 (None), 1 (Localized), 2 (Widespread).
    • Periosteal bone formation: Scored as 0 (None), 1 (Localized), 2 (Widespread).
    • Sequestration: Scored as 0 (None), 1 (Localized), 2 (Widespread). Radiographs will be taken at the initial visit to establish a baseline for each patient. Subsequent radiographs will be taken only if clinically indicated to monitor the presence and progression of osteonecrotic lesions.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start25 Apr 2024
  3. Primary completion25 Apr 2026 (estimated)
  4. Study completion26 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06430762
Sponsor's protocol ID
CIBON-MAR-A.1
Status last verified
May 2024
First submitted
21 May 2024
Last updated
28 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21.

    PubMed 35300956

  • Friendlander AH, Ettinger RL. Karnofsky performance status scale. Spec Care Dentist. 2009 Jul-Aug;29(4):147-8. doi: 10.1111/j.1754-4505.2009.00088.x. No abstract available.

    PubMed 19573040

  • Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

    PubMed 9332805

Questions about this trial

What is this clinical trial studying?

An observational study of Medication-Related Osteonecrosis of Jaw, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ferit Bayram, PhD (00902167775000, ferit.bayram@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Karnofsky Performance Status (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06430762, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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