UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Estimation of usefulness of intravenous admnistration of alendoronate for bone disorders after gastrectomy
Title of the study (Brief title)	Estimation of usefulness of intravenous admnistration of alendoronate for bone disorders after gastrectomy
Region	Japan

Condition
Condition	Distrubances of bone tissue metabolism
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the usefulness of orally administered jelly alendoronate and intravenously administered alendronate in patients receiving gastrectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Bone mineral density (L1-4)
Key secondary outcomes	1. Bone mineral density of the total hip 2. Bone turnover markers (serum BAP, serum NTx, Serum TPACP-5b) 3. Adverse effect

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravnous alendoronate group: Intravenous administration of 100 ml of alendronate at once per month. One course is one month and this treatment is continued 12 courses.
Interventions/Control_2	Jelly alendronate group: A 35 mg of jelly type alndronate was orally administered at once per week One course is one month and this treatment is continued 12 courses..
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients aged more than 20 years . 2. Patients with osteoporosis diagnozed by DXA method (definition of osteoporosis: YAM value is under 80 %) 3. Patients underwent gastrectomy 4. Patients with bone fracture or YAM value is under -1.5SD. 5. Patients without treatments for malignancies 6. Patients without past history of invasive dental treatments within 3 months 7. Patients who gaved informed consent.
Key exclusion criteria	1. Patients with some diseaes which may be worse by the participation of this study. 2. Pregnant patients or patients who hope pregnancy 3. Patients who are judged inappropriate by doctors
Target sample size	46

Research contact person
Name of lead principal investigator	Chikara Kunisaki
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Hirochika Makino
Organization	Gastroenterological Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	hirochika@hotmail.com

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 08 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 28 Day
Last modified on	2017 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014193