A study on changes in nutritional status in patients with medication-related osteonecrosis of the jaw

Phase 2

Recruiting

• Conditions: Medication-related osteonecrosis of the jaw; osteonecrosis of the jaw, bisphosphonate, denosumab; D059266

• Registration Number: JPRN-jRCT1071230057
• Lead Sponsor: Ogata Kinuko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-05
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients aged 18 years or older at the time of informed consent
Regardless of gender
Performance Status From 0 to 2
Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study

Exclusion Criteria

Patients who have difficulty in taking nutritional supplements orally before surgery
For example, patients with severe dementia or on parenteral nutrition
Patients on dialysis
Patients with diabetes (HbA1c of 6.5 or high)
Obese patients (BMI of 25 or high)
Patients with milk allergy or soy allergy
Other patients who are judged by the attending physician to be inappropriate as research subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
utritional status 8 days after surgery (serum albumin, ser um total protein, prealbumin)

Secondary Outcome Measures

Name	Time	Method
Presence or absence of postoperative complications, changes in nutritional status 1 to 3 months after surgery (weight change rate, BMI, CONUT value)