臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 25, 2026
Last modified on	Feb. 25, 2026
Trial ID	jRCT1041250187

Scientific Title	Comparative Effectiveness of Early Treatment Intervention for Osteoporosis After Kidney Transplantation
Public Title	A Study Evaluating the Efficacy of Early Therapeutic Intervention for Osteoporosis After Kidney Transplantation

Contact for Scientific Queries	Name	Yuki Hasegawa
	Affiliation	Japanease red cross aichi medical center nagoya daini hospital
	Address	2-9,Myoken-chou,syowa-ku,nagoya,aichi
	Telephone	+81-52-832-1121
	E-mail	yhasegawa@nagoya2.jrc.or.jp
Contact for Public Queries	Name	Yuki Hasegawa
	Affiliation	Japanease red cross aichi medical center nagoya daini hospital
	Address	2-9,Myoken-chou,syowa-ku,nagoya,aichi
	Telephone	+81-52-832-1121
	E-mail	yhasegawa@nagoya2.jrc.or.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 25, 2026
Target sample size		144
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	During the 4-year period following approval to conduct the study, the study population will comprise patients with osteoporosis who undergo kidney transplantation for end-stage kidney disease and are followed as outpatients at the Departments of Transplant Surgery and Transplant Nephrology, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital. Inclusion criteria Adult kidney transplant candidates aged >20 years (written informed consent will be obtained before transplantation). A preoperative DEXA scan performed within 3 months prior to transplantation showing a T-score <-2.5. Stable postoperative renal function with eGFR >30. Ability to provide written informed consent.
	Exclusion Criteria	Prior treatment for severe osteoporosis within the past 12 months. Patients considered to require therapeutic intervention for hyperparathyroidism. Pregnant women or women with the potential to become pregnant. Hypocalcemia (corrected serum calcium < 8.0 mg/dL). Patients without immediate graft function (i.e., no evidence of early post-transplant graft function). Any other patients deemed inappropriate for study participation by the principal investigator.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Osteoporosis after kidney transplantation
Intervention(s)		Early intervention group (Group A): Initiation of osteoporosis pharmacotherapy within 2 to 4 weeks after transplantation. Study drugs: denosumab (60 mg subcutaneously every 6 months). If the DEXA T-score is -3.0 or lower, romosozumab (210 mg subcutaneously once monthly). The treating physician will determine drug selection based on renal function, patient preference, and risk of adverse events. Deferred treatment group (Group B): Initiation of osteoporosis pharmacotherapy at 6 months after transplantation. The study drugs and any supplementation therapy will be the same as in Group A. Common components (both groups): Immunosuppressive therapy: administered according to the institution's standard protocol. If feasible, we intend to standardize the regimen to triple therapy with tacrolimus, mycophenolate mofetil, and prednisolone, as this is the most commonly used protocol at our institution. Lifestyle counseling: all participants will receive counseling on smoking cessation, moderate exercise, and fall-prevention strategies. These measures are also part of routine clinical care.
Health Condition(s) Keyword		osteoporosis
Intervention(s) Keyword		drnodumsb
Health Condition(s) Code		D010024
Intervention(s) Code		D000069448
Primary Outcome(s)		Percent change in lumbar spine bone mineral density (BMD)
Secondary Outcome(s)		Percent change in femoral BMD Fracture incidence Incidence of complications

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board (IRB), Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Address	2-9,Myoken-chou,Myowa-ku,nagoya,aichi, Aichi
Telephone	+81-52-832-1121
E-Mail	irb-gimu@nagoya2.jrc.or.jp
Approval Status	Approval
Date of approval	Feb. 13, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none