UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

San-ei Sucrochemical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2016

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

12

Month

26

Day

Last modified on

2017

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029198