UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013745 |
|---|---|
| Receipt number | R000016040 |
| Scientific Title | Phase II randomized trial of alendronate to compare oral and intravenous administration for bone mineral density in gastrectomized patients |
| Date of disclosure of the study information | 2014/04/17 |
| Last modified on | 2022/03/16 13:18:56 |
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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
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
tknbymd@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016040
