臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 02, 2024
Last modified on	May. 01, 2025
Trial ID	jRCTs041240136

Scientific Title	The efficacy and safety of teriparatide among patients with chronic kidney disease stage 4 and 5
Public Title	The efficacy and safety of teriparatide in advanced chronic kidney disease

Contact for Scientific Queries	Name	Hamano Takayuki
	Affiliation	Nagoya City University Hospital
	Address	1,Kawasumi,Mizuho-chou,Mizuho-ku,Nagoya,Aichi
	Telephone	+81-52-858-7429
	E-mail	hamatea@med.nagoya-cu.ac.jp
Contact for Public Queries	Name	Kodai Suzuki
	Affiliation	Nagoya City University Hospital
	Address	1,Kawasumi,Mizuho-chou,Mizuho-ku,Nagoya,Aichi
	Telephone	+81-52-858-7429
	E-mail	kodais@med.nagoya-cu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 02, 2024
Actual date of first enrollment
Target sample size		35
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 with chronic kidney disease stage 4 and 5 and meeting one of the following criteria 1. Meeting criteria for the diagnosis of osteoporosis 2. Trabecular bone score less than -2.0 and T score of bone mineral density more than -2.5 and less than -1.0
	Exclusion Criteria	1. Those on maintenance dialysis or expecting the initiation of dialysis within 2 years 2. Those who had kidney transplantation 3. Those on corticosteroid treatment, i.e. prednisolone equivalent dose more than 5mg a day 4. Intact PTH 150 pg/mL and over 5. Bone Paget disease 6. Alkaline phosphatase twice the upper limit of reference range or over 7. Previous radiation therapy to bones 8. Hypercalcemia 9. Primary bone malignancy or metastatic bone malignancy 10. Allergy to teriparatide 11. Pregnant women 12. Previous therapy with teriparatide
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Osteoporosis, osteopenia
Intervention(s)		Teriparatide 28.2 microg subcutaneous injection twice a year for two years
Health Condition(s) Keyword		Osteoporosis, osteopenia
Intervention(s) Keyword		Teriparatide
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Increase in trabecular bone score in lumbar spine bone mineral density after 2 years
Secondary Outcome(s)		Bone mineral densities, trabecular volumetric bone mineral densities and cortical volumetric bone mineral densities measured by 3D SHAPER, trabecular bone score after 1 year, and bone mineral markers such as calcium, phosphate, PTH, bone specific alkaline phosphatase, tartrate-resistant acid phosphatase-5b

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagoya City University Certified Review Board
Address	1,Kawasumi,Mizuhocho,Mizuhoku,Nagoya,Aichi, Aichi
Telephone	+81-52-853-8346
E-Mail	rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	Nov. 12, 2024

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
2	May. 01, 2025	(this page)	Changes
1	Dec. 02, 2024	Detail

List of change history