臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 09, 2013
Last modified on	Aug. 05, 2015
Trial ID	jRCT1091220155

Scientific Title	Treatment of renal transplant recipients with low bone mineral density and vascular calcification: a prospective study of alendronate therapy.
Public Title	Treatment of renal transplant recipients with low bone mineral density and vascular calcification: a prospective study of alendronate therapy.

Contact for Scientific Queries	Investigator Name	Masanori Okamoto
	Investigator Organization	Wakayama Medical University
	Address	811-1 Kimiidera, Wakayama City, Wakayama, 641-0012
	TEL	+81-73-441-0639
	E-mail	mokamoto@wakayama-med.ac.jp
Contact for Public Queries	Contact Name	Masanori Okamoto
	Contact Organization	Wakayama Medical University
	Address	811-1 Kimiidera, Wakayama City, Wakayama, 641-0012
	TEL	+81-73-441-0639
	E-mail	mokamoto@wakayama-med.ac.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Oct. 01, 2007
Planned Number of Subjects		20
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Parallel-Group Comparative Study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Kidney transplant recipients for secondary osteoporosis with stable allograft function (defined by serum creatinine < 2.0 mg/dL) for at least 1 year
	Exclusion Criteria	Patients which are administered bisphosphonate or underwent parathyroidectomy(PTx) within 12 months prior to the informed consent.
	Minimum Age	No limit
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Kidney transplant recipients for secondary osteoporosis and vascular calcification
Intervention(s)		Intervention type:DRUG Name of intervention:alendronate Dose form / Japanese Medical Device Nomenclature:TABLET Route of administration / Site of application:ORAL Dose per administration:35 mg Dosing frequency / Frequency of use:QW Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name:none Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		bone mineral density (BMD) aortic calcification index (ACI)
Secondary Outcome(s)		bone turnover markers, renal function

Primary Sponsor	Masanori Okamoto
Secondary Sponsor

Sources of funding	MSD K.K.

Name of Ethics Committee	Ethics Committee of Wakayama Medical University
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Sept. 20, 2006

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Secondary Study ID	JMA-IIA00155
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Aug. 05, 2015	(this page)	Changes
1	Dec. 09, 2013	Detail

List of change history