UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020267 |
|---|---|
| Receipt number | R000023337 |
| Scientific Title | Quantitative assessment of the eldecalcitol effect on intestinal calcium absorption |
| Date of disclosure of the study information | 2015/12/19 |
| Last modified on | 2017/12/19 13:02:37 |
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Basic information
Public title
Quantitative assessment of the eldecalcitol effect on intestinal calcium absorption
Acronym
Quantitative assessment of the eldecalcitol (ELD) effect on intestinal calcium absorption and comparison between ELD group, alfacalcidol (ALF) group, natural vitamin D group and non-treatment group with Osteoporotic women patients.(CalQ study)
Scientific Title
Quantitative assessment of the eldecalcitol effect on intestinal calcium absorption
Scientific Title:Acronym
Quantitative assessment of the eldecalcitol (ELD) effect on intestinal calcium absorption and comparison between ELD group, alfacalcidol (ALF) group, natural vitamin D group and non-treatment group with Osteoporotic women patients.(CalQ study)
Region
| Japan |
Condition
Condition
Primary osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantitative assessment of the eldecalcitol (ELD) effect on intestinal calcium absorption by a Dual Stable-Isotope Method with Osteoporotic women patients. Comparison between ELD group, alfacalcidol (ALF) group, natural vitamin D group and non-treatment group.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Efficacy
Percent change of calcium absorption from baseline in the ELD group.
2. Safety
Summarizing and aggregation of number and frequency of all adverse events occurring.
The point of assessment for efficacy and safety is 28 days after starting administration.
Key secondary outcomes
Efficacy
1) Secondary outcomes
1. Percent change of calcium absorption from baseline in groups without ELD group.
2. Comparison the percent change of calcium absorption from baseline between groups.
3. Comparison the ratio of calcium absorption from baseline between groups.
4. Comparison the ratio of calcium absorption at final dosing between groups.
2) Other outcomes
1. Percent change of uNTX from baseline in groups
2. Comparison the percent change of uNTX from baseline between groups.
3. Change of calcium and phosphorus regulation-hormones (25(OH)D, 1,25(OH)2D, intact-PTH, FGF23) from baseline in the group.
4. Comparison calcium and phosphorus regulation-hormones at the pre-dosing and post-dosing between groups.
5. Relationship between subjects' background of screening or pre-dosing examination or calcium related test items and calcium absorption ratio from intestine.
6. Relationship between subjects' background of screening or pre-dosing examination or calcium related test items and percent change of calcium absorption ratio from intestine.
7. Relationship between calcium related test items or calcium and phosphorus regulation-hormones and change in intestinal calcium absorption ratio between pre-dosing and post-dosing in each group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
Eldecalcitol 0.75ug/day (28 days)
Interventions/Control_2
Alfacalcidol 1ug/day (28 days)
Interventions/Control_3
Native vitamin D 800IU/day (28days)
Interventions/Control_4
Non-treatment group (28 days)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Subject with postmenopausal primary osteoporosis.
2) Subject with major osteoporotic fracture risk is 10% or more and less than 25% by FRAX at screening examination.
3) Subject with 60 years old or more and 80 years old or less.
4) Subject with a written consent to participation in this study by their free will.
Key exclusion criteria
1) Has a history of fragility fracture within a year.
2) Has complication or using medicines as follows.
1. Endocrine disease
2. Malignancy
3. Poor nutrition (undernourishment)
4. Gout
5. Lactose intolerance
3) Has gastric resection or gastric bypass surgery.
4) Has taken bisphosphonate medicine (included investigational new drug) within 6 months before starting of dosing.
5) Has taken RANKL antibody in the past at a time.
6) Has taken following medications effected to born metabolism within 4 weeks before dosing.
1. Selective estrogen receptor modulators formulation
2. Calcitonin preparation
3. Vitamin K2 preparation
4. Ipriflavone preparation
5. Sex hormone preparation
(without tablet or cream vaginal agents)
6. Active vitamin D3 preparation
7. Native vitamin D preparation
8. Ca preparation
9. Other drug or supplement those effect to born metabolism.
7) Has taken following drugs effected to Ca absorption and elimination within 4 weeks before dosing.
1. Steroid preparation (excluded external preparation and local injection with inhalation, nasal preparation)
2. Other drugs or supplements effected to Ca absorption and elimination.
8) Has taken parathyroid hormone preparation in the past at a time.
9) Has taken anti- sclerostin antibody or cathepsin K-inhibitor in the past at a time.
10) Has taken other investigational new drug (included placebo) within 16 weeks before dosing.
11) Has caught extreme rays by sunbath at a resort within a month before dosing.
12) Serum Ca at the registration is more than 10.4 mg/dL or less than 8.0 mg/dL.
13) Urine Ca is over than 0.4 mg/dL GF.
14) Has currently or a history of urinary tract stone.
15) eGFR at registration is less than 30mL/min/1.73m2.
16) Has advanced liver disease like cirrhosis or advanced heart disease like serious heart failure.
17) Has hypersensitivity to ELD, ALF or other vitamin D preparation.
18) Other people who are judged by the investigator or the subinvestigator as inappropriate to participate in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Shiraki |
Organization
Research Institute and Practice for Involutional Diseases
Division name
The head
Zip code
Address
1610-1 Misatomeisei Azumino, Nagano 399-8101 Japan
TEL
0263-77-2134(+81-263-77-2134)
shikari_m@icloud.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Mabuchi |
Organization
IDD, Inc.
Division name
Business Planning Office; Foreign Affairs Dept.
Zip code
Address
Okino Bldg. 201, 2-14-19, Minami Azabu, Minato-ku, Tokyo 106-0047 Japan
TEL
03-3473-0100(+81-3-3473-0100)
Homepage URL
mabuchi@idd-inc.co.jp
Sponsor or person
Institute
Research secretariat
(IDD, Inc.)
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kazuhiro Uenishi
Professor, Laboratory of Physiological Nutrition,
Kagawa Nutrition University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団慶幸会 ピーワンクリニック（東京都）
(P-One Clinic, Keikokai Medical Corporation (Tokyo))
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 06 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 08 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023337
