臨床研究等提出・公開システム

Scientific Title	Efficacy and safety of zoledronic acid for postmenopausal women with early breast cancer receiving adjuvant aromatase inhibitor. (SBP-15)
Public Title	SBP-15 (SBP-15)

Contact for Scientific Queries	Name	Tadahiko Shien
	Affiliation	Okayama University Hospital
	Address	2-5-1Shikata-cho, Kita-ku, Okayama, Japan
	Telephone	+81-86-235-7265
	E-mail	tshien@md.okayama-u.ac.jp
Contact for Public Queries	Name	Tadahiko Shien
	Affiliation	Okayama University Hospital
	Address	2-5-1Shikata-cho, Kita-ku, Okayama, Japan
	Telephone	+81-86-235-7265
	E-mail	tshien@md.okayama-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		June. 07, 2021
Actual date of first enrollment		July. 07, 2021
Target sample size		200
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	ER positive postmenopausal breast cancer patients Patients recieving AI (<2 yerars) Patients diagnosed osteoporosis Patients without treatment of osteoporosis CCr>35mL/min Serum Ca>8.0 mg/dL Without dental treatment With informed consent
	Exclusion Criteria	Metastatic breast cancer patients Allargy with bisphosphonate Renal disfunction Active other cancers Treated with bisphosphonate The medical doctor judged ineligible
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		ER positive early breast cancer
Intervention(s)		Treatment of AI induced osteoporosis by Bisphosphonate (Zoledronic acid hydrate 5mg/year div. >15min)
Health Condition(s) Keyword		aromatase inhibitors induced osteoporosis
Intervention(s) Keyword		Treatment of AI induced osteoporosis by Bisphosphonate
Primary Outcome(s)		3 years rate of bone density change
Secondary Outcome(s)		5 years rate of bone metastasis 5 years rate of desiese free survival Safety Rate of fructure of vertebral bone Rate of fructutre of non-vertrbral bone

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Okayama University Certified Review Board
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Telephone	+81-86-235-7133
E-Mail	ouh-crrb@adm.okayama-u.ac.jp
Approval Status	Approval
Date of approval	April. 27, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history