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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020267
Receipt No. 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

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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)
Email 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
Email mabuchi@idd-inc.co.jp

Sponsor
Institute Research secretariat
(IDD, Inc.)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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