UMIN-CTR Clinical Trial

Basic information
Public title	Phase II randomized trial of alendronate to compare oral and intravenous administration for bone mineral density in gastrectomized patients
Acronym	Phase II randomized trial of alendronate to compare oral and intravenous administration for bone mineral density in gastrectomized patients
Scientific Title	Phase II randomized trial of alendronate to compare oral and intravenous administration for bone mineral density in gastrectomized patients
Scientific Title:Acronym	Phase II randomized trial of alendronate to compare oral and intravenous administration for bone mineral density in gastrectomized patients
Region	Japan

Condition
Condition	osteoporosis after gastrectomy
Classification by specialty	Gastrointestinal surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of oral or intaravenous administration of alendronate in gastrectomized patients who developed osteoporosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Change of bone mineral density after one year administration of alendronate
Key secondary outcomes	Compliance of alendronate and activated vitamin-D3 Adverse events of alendronate and activated vitamin-D3

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral alendronate (35mg/week) for 12 months
Interventions/Control_2	intravenous alendronate (900ug/4week) + vit-D3 (1.0ug/day) for 12 months
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 who underwent gastrectomy within five years. 2. Pathological stageI patients or stages II/III patients without recurrence for at least three years after surgery. 3. Bone mineral density <80% of the YAM (young adult mean) assessed by dual-energy x-ray absorptiometry. 4. Age 20 years and over. 5. Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 6. Serum levels of alkaline phosphatase, calcium, phosphorus, 1,25-dihydroxyvitamin D3 and undercaboxylated osteocalcin were within the normal range. 7. Signed informed consent documents
Key exclusion criteria	1. Patients who received local resection of the stomach 2. Patients who receive chemotherapy due to recurrent or remnant gastric cancer 3. Passage disturbance of esophagus due to achalasia or mechanical stenosis 4. Uncontrolled reflux esophagitis even by medication 5. Renal dysfunction or serum creatinine 1.5mg/dL or less 6. Scoliosis or compressed fracture of lumbar spine 7. Patients who received or plans extraction of tooth within three months 8. Previous treatment of bisphosphonate within six months 9. Patients who receive thyroid hormone or antithyroid hormone 10. Diabetes mellitus controlled by insulin 11. Patients who receive warfarin 12. Patients who receive any medication affecting bone metabolism. 13. Patients who have mental disorder or severe mental symptom 14. Allergy to the alendronate and vitamin D3 15. Other active malignancy occurring within 5 years before enrollment 16. Patients who are judged as inappropriate for study entry by the investigators
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Oshima
Organization	Kanagawa Cancer Center
Division name	Department of Gastrointestinal Surgery
Zip code	241-8515
Address	2-3-2 Nakao, Asahi-ku, Yokohama City, 241-8515, Japan
TEL	045-520-2222
Email	oshimat@kcch.jp

Public contact
Name of contact person	1st name Takanobu Middle name Last name Yamada
Organization	Kanagawa Cancer Center
Division name	Department of Gastrointestinal Surgery
Zip code	241-8515
Address	2-3-2 Nakao, Asahi-ku, Yokohama City, 241-8515, Japan
TEL	045-520-2222
Homepage URL
Email	tknbymd@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center
Institute
Department

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

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

IRB Contact (For public release)
Organization	Kanagawa Cancer Center Ethics Committee
Address	2-3-2 Nakao, Asahi-ku, Yokohama City, 241-8515, Japan
Tel	045-520-2222
Email	ycu.umin@gmail.com

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

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 11 Day
Date of IRB	2014 Year 03 Month 13 Day
Anticipated trial start date	2014 Year 04 Month 21 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 17 Day
Last modified on	2022 Year 03 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016040