UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study of improvements in bone density: a randomized double-blind placebo-controlled study
Title of the study (Brief title)	A verification study of improvements in bone density
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of improvements in bone density with the intake of test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Dual Energy X-ray Absorptiometry (DEXA) Left femoral neck fracture: Bone area, bone mineral density, bone density ,T-score, YAM score, Z score Lumbar spine total amount: Bone area, bone mineral density, bone density ,T-score, YAM score, Z score
Key secondary outcomes	1. Peripheral blood test TRACP-5b, OC, BAP 2. Subjective symptoms Questionnaire of physical and life related to osteoporosis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 24 weeks Test materials: Maltobionic acid containing corn syrup solid (Oligo-sugar acid of calcium) Dose: 2 packs, once a day (8 g) Administration: Take 2 packs after meal with water, warm water, coffee, apple juice, or etc.
Interventions/Control_2	Duration: 24 weeks Test materials: Placebo Dose: 2 packs, once a day (8 g) Administration: Take 2 packs after meal with water, warm water, coffee, apple juice, or etc.
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	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Female
Key inclusion criteria	1. Healthy Japanese adult females 2. Those who are menopause for at least 1 year 3. Those who had no abnormity in screening urinalysis 4. Those who have 72-100% of YAM score of femoral neck fracture and lumbar spine total amount at screening and examination before ingestion. Select criteria are that those who have closer to 72% of YAM score of either femoral neck fracture or lumbar spine total amount. In case of the selected number small the sample size, select one of closer to 100%.
Key exclusion criteria	1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 5. Those who take "Foods for Specified Health Uses," "Foods with Functional Claims," or supplements; calcium, vitamin D, vitamin K, magnesium, isoflavones, (included Daidzein, genistein, Equol and etc.) related to bone metabolism more than once a week 6. Those who are allergic to medicines and/or the test food related products 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Others consider as inappropriate for this test by the doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	San-ei Sucrochemical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic
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 盛心会 タカラクリニック (東京都) Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 12 Day
Anticipated trial start date	2016 Year 12 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 26 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029198