臨床研究等提出・公開システム

Date of registration	Sept. 12, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220084

Scientific Title	Multicenter, double-blind randomized, controlled study for the treatment of involutional 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	Ono Pharmaceutical Co., Ltd.
	Address	06-6263-5670
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	double-blind randomized, controlled study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients of female aged 55 years or older and under 81 years with documented involutional osteoporosis with prevalent fracture according to the diagnostic criteria for primaly osteoporosis
	Exclusion Criteria
	Minimum Age	55age old over
	Maximum Age	80age old under
	Gender	Female
Health Condition or Problem Studied		Involutional osteoporosis
Intervention(s)		investigational material(s) Generic name etc : ONO-5920 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy, Safety
Secondary Outcome

Primary Sponsor	ONO PHARMACEUTICAL 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-050086
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Dec. 05, 2006	Detail	Changes
3	Dec. 05, 2006	Detail	Changes
2	Sept. 12, 2005	Detail	Changes
1	Sept. 12, 2005	Detail

List of change history