UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031489
Receipt number R000035947
Scientific Title A verification study of improvements in bone density: a randomized double-blind placebo-controlled study
Date of disclosure of the study information 2018/02/26
Last modified on 2019/05/31 09:58:24

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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 Japanese adult people

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 intake of the test food

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Bone density of total amount of lumbar vertebra

* Measured by Dual Energy X-ray Absorptiometry (DEXA)
* Perform the test at screening and examination before consuming and at 12 and 24 weeks after ingestion

Key secondary outcomes

1. Left femur (thigh bone) (neck, trochanter, inter, total amount, and Ward' s): Bone area, bone mineral density, bone density, T-score, YAM score, and Z score

2. Lumbar vertebra (L2, L3, L4, and total amount): Bone area, bone mineral density, T-score, YAM score, and Z score

3. Peripheral blood test
Tartrate-resistant Acid Phosphatase 5b (TRACP-5b), osteocalcin (OC), bone specific alkaline phosphatase (BAP), crosslinked N-telopeptide of type I collagen (NTx)

4. Urinalysis
Crosslinked N-telopeptide of type I collagen (NTx), deoxypyridinoline (DPD)

5. Subjective symptoms
Questionnaire of physical and life related to osteoporosis

*1,2 Measured by Dual Energy X-ray Absorptiometry (DEXA)
*1-5 Perform the tests at screening and examination before consuming and at 12 and 24 weeks after ingestion


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 24 weeks
Test materials: Corn syrup containing maltobionic acid
Dose: 7 g/day
Administration: Take it during or after meal with water, carbonated water, milk, or apple juice, even with salad, fruits, yogurt, or etc.

* If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 24 weeks
Test materials: maltose syrup
Dose: 7 g/day
Administration: Take it with or after meal with water, carbonated water, milk, or apple juice, or even with salad, fruits, yogurt, or etc.

* If you forget to take the test food, take it as soon as you remember within the day.

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. Japanese adult female

2. Subjects who are menopause (natural menopause) for at least 1 year

3. Subjects who are judged as eligible to participate in the study by the physician

4. Subjects who have 70% or more but less than 100% in total amount of lumbar vertebra (the mean in young adults) of YAM score at screening and examination before consuming. If number of subjects who passed the inclusion criteria is below the sample size, select them whose YAM scores are closer to 100%

Key exclusion criteria

1. A medical history of malignant tumor, heart failure or myocardial infarction

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who take supplements, "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" related to bone metabolism, such as calcium, vitamin D, vitamin K, magnesium, isoflavones, (included daidzein, genistein, equol, or etc.), more than once a week

4. Currently taking medications (include herbal medicines), "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage

5. Subjects who are allergic to medicines and/or the test food related products

6. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

7. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

34


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp


Public contact

Name of contact person

1st name Naoko
Middle name
Last name SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

Kazuo

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



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

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

info@takara-clinic.com


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)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2018 Year 02 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

38

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

2018 Year 02 Month 20 Day

Date of IRB

2018 Year 02 Month 20 Day

Anticipated trial start date

2018 Year 02 Month 27 Day

Last follow-up date

2018 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 26 Day

Last modified on

2019 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035947


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name