臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 05, 2023
Last modified on	Oct. 15, 2024
Trial ID	jRCT1071230057

Scientific Title	A study on changes in nutritional status due to nutritional supplementation in patients with medication-related osteonecrosis of the jaw
Public Title	A study on changes in nutritional status in patients with medication-related osteonecrosis of the jaw

Contact for Scientific Queries	Name	Hara Masahito
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501
	Telephone	+81-95-819-7704
	E-mail	hara.m@nagasaki-u.ac.jp
Contact for Public Queries	Name	Hara Masahito
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501
	Telephone	+81-95-819-7704
	E-mail	hara.m@nagasaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 05, 2023
Actual date of first enrollment		Oct. 16, 2023
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Medication-related osteonecrosis of the jaw
Intervention(s)		Patients who meet the registration requirements are aske d to take two nutritional supplements (whey peptide-cont aining liquid diet) a day for a total of 14 days, 7 days befor e surgery and 7 days after surgery. Evaluation of improvement in nutritional status and safety evaluation will be performed on the 8th day after surgery.
Health Condition(s) Keyword		osteonecrosis of the jaw, bisphosphonate, denosumab
Intervention(s) Keyword		nutrient, whey peptide-containing liquid diet
Health Condition(s) Code		D059266
Intervention(s) Code
Primary Outcome(s)		Nutritional status 8 days after surgery (serum albumin, ser um total protein, prealbumin)
Secondary Outcome(s)		Presence or absence of postoperative complications, changes in nutritional status 1 to 3 months after surgery (weight change rate, BMI, CONUT value)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The Clinical Research Review Board in Nagasaki Universit y
Address	1-7-1 Sakamoto, Nagasaki, Nagasaki, Nagasaki, Nagasaki
Telephone	+81-95-819-7229
E-Mail	gaibushikin@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 31, 2023

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	Oct. 15, 2024	(this page)	Changes
6	Oct. 11, 2024	Detail	Changes
5	June. 13, 2024	Detail	Changes
4	May. 14, 2024	Detail	Changes
3	April. 15, 2024	Detail	Changes
2	Oct. 21, 2023	Detail	Changes
1	Sept. 05, 2023	Detail

List of change history