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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025401
Receipt No. R000029198
Scientific Title A verification study of improvements in bone density: a randomized double-blind placebo-controlled study
Date of disclosure of the study information 2016/12/26
Last modified on 2017/10/16

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Basic information
Public title A verification study of improvements in bone density: a randomized double-blind placebo-controlled study
Acronym A verification study of improvements in bone density
Scientific Title A verification study of improvements in bone density: a randomized double-blind placebo-controlled study
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
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
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

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
2016 Year 12 Month 12 Day
Date of IRB
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

Other
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

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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