臨床研究等提出・公開システム

Date of registration	July. 16, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220769

Scientific Title	Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
	Exclusion Criteria
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Involutional (postmenopausal and senile) osteoporosis
Intervention(s)		investigational material(s) Generic name etc : Denosumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subcutaneous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090797
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
12	Dec. 17, 2018	(this page)	Changes
11	Feb. 18, 2015	Detail	Changes
10	Feb. 18, 2015	Detail	Changes
9	Sept. 30, 2014	Detail	Changes
8	Sept. 30, 2014	Detail	Changes
7	Sept. 30, 2014	Detail	Changes
6	Sept. 30, 2014	Detail	Changes
5	Mar. 13, 2013	Detail	Changes
4	Mar. 13, 2013	Detail	Changes
3	Jan. 27, 2011	Detail	Changes
2	July. 16, 2009	Detail	Changes
1	July. 16, 2009	Detail

List of change history