臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 20, 2023
Last modified on	April. 02, 2023
Trial ID	jRCT1051220150

Scientific Title	Equivalence Trial of Denosumab vs Zoledronate Following Romosozumab (DZR Trial)
Public Title	Comparison of Denosumab and Zoledronate following Romosozumab

Contact for Scientific Queries	Name	Takahashi Shinji
	Affiliation	Osaka Metropolitan University Hospital
	Address	1-4-3, Asahimachi, Abenoku, Osaka
	Telephone	+81-6-6645-3851
	E-mail	stakahashi@omu.ac.jp
Contact for Public Queries	Name	Takahashi Shinji
	Affiliation	Osaka Metropolitan University Hospital
	Address	1-4-3, Asahimachi, Abeno-ku, Osaka
	Telephone	+81-666453851
	E-mail	stakahashi@omu.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 20, 2023
Target sample size		65
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients on romosozumab for osteoporosis who are 50 years of age or older and have one of the following criteria at the time of starting romosozumab 1. bone mineral density less than 2.5 SD and more than 1 fragility fracture 2. lumbar spine bone density less than -3.3 SD 3. more than 2 existing vertebral fractures 4. semi-quantitative evaluation method result of existing vertebral fracture is Genant grade 3. 5. judged to be necessary to improve surgical outcomes for osteoporosis 6. more than 7.5 mg of steroids (more than 3 months) and T-score <-2.5 Bone fracture despite treatment with bone resorption inhibitors 8. persistent loss of bone mineral density despite treatment with bone resorption inhibitors Translated with www.DeepL.com/Translator (free version)
	Exclusion Criteria	1. patients with severe renal dysfunction (creatinine clearance <35 mL/min) 2. patients with a history of hypersensitivity to denosumab or bisphosphonates 3. patients with dehydration (high fever, severe diarrhea, vomiting, etc.) 4. patients with hypocalcemia
	Age Minimum	50age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Osteoporosis
Intervention(s)		Denosumab or zoledronate after romosozumab
Health Condition(s) Keyword		osteoporosis, denosumab, zoledronate, romosozumab
Intervention(s) Keyword		denosumab, zoledronate, romosozumab
Health Condition(s) Code		D010024
Intervention(s) Code		D000069448, D000077211
Primary Outcome(s)		Bone mineral density (Lumbar spine, Total hip)
Secondary Outcome(s)		Bone metabolism (P1NP, TRACP-5b)

Secondary Sponsor

Name of Certified Review Board	Osaka Metropolitan University Hospital Certified Review Board
Address	ABENO MEDIX 6F,1-2-7 Asahi-machi, Abeno-ku, Osaka, Osaka, Osaka
Telephone	+81-6-6645-3456
E-Mail	gr-a-knky-crb@omu.ac.jp
Approval Status	Approval
Date of approval	Jan. 05, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 02, 2023	(this page)	Changes
1	Jan. 20, 2023	Detail

List of change history