UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative assessment of the eldecalcitol effect on intestinal calcium absorption
Title of the study (Brief title)	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	Masataka Shiraki
Organization	Research Institute and Practice for Involutional Diseases
Division name	The head
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	Yasuo Mabuchi
Organization	IDD, Inc.
Division name	Business Planning Office; Foreign Affairs Dept.
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023337