UMIN-CTR Clinical Trial

Public title

Effects of the BONE Program on Bone Health, Peripheral Circulation, and Glycation in Older Women

Acronym

BONE Trial

Scientific Title

Effects of the BONE Program on Bone Health, Peripheral Circulation, and Glycation-Related Indices in Older Women: A Randomized Wait-list Controlled Trial

Scientific Title:Acronym

BONE Randomized Wait-list Trial

Region

Japan

Condition

Bone health in older women (not limited to a specific disease)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to investigate the effects of a once-weekly, 2-month BONE exercise program on bone health, peripheral circulation, and glycation-related indices in community-dwelling older women. All participants will initially undergo a 2-month control period and will then be randomly assigned to two groups with different intervention start times using a wait-list controlled design. The effect of the BONE program will be evaluated by comparing the early-start group with the delayed-start group during the same study period. All participants will ultimately receive the BONE intervention, allowing additional within-participant comparisons between control and intervention periods. Bone health will be assessed using lumbar spine bone mineral density measured by REMS and ultrasound-based bone parameters of the radius. Peripheral circulation will be assessed using estimated hemoglobin levels, vessel width, VOI, and finger surface temperature measured by ASTRIM FIT. Glycation-related indices will be assessed using the AGE Scanner.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Change in lumbar spine bone mineral density assessed by radiofrequency echographic multi-spectrometry (REMS) using the EchoS system. The change from month 2 to month 4 during the BONE intervention period in the early-start group will be compared with the change during the corresponding wait-list control period in the delayed-start group.

Key secondary outcomes

1. Changes in ultrasound-based bone parameters of the radius.
2. Changes in estimated hemoglobin levels measured by ASTRIM FIT.
3. Changes in vessel width measured by ASTRIM FIT.
4. Changes in VOI measured by ASTRIM FIT.
5. Changes in finger surface temperature measured by ASTRIM FIT.
6. Changes in AGE accumulation-related indices assessed using the AGE Scanner.
7. Changes in each outcome from immediately before to after the 2-month BONE intervention in all participants.
8. Within-participant comparison of changes during a 2-month control period and a 2-month BONE intervention period in all participants.
9. Changes in study outcomes during the 2-month post-intervention follow-up period in the early-start group.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Participants will continue their usual daily activities without the BONE program during the initial 2-month control period. Following randomization at month 2, participants will receive the BONE exercise program once weekly for 2 months, from month 2 to month 4. They will subsequently undergo a 2-month post-intervention follow-up period from month 4 to month 6. Assessments will be performed at baseline and at months 2, 4, and 6.

Interventions/Control_2

Participants will continue their usual daily activities without the BONE program during the initial 4-month wait-list control period. Following randomization at month 2, participants will remain on the wait-list for an additional 2 months and will then receive the BONE exercise program once weekly for 2 months, from month 4 to month 6. Assessments will be performed at baseline and at months 2, 4, and 6.

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

60

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1. Community-dwelling women aged 60 years or older.
2. Individuals who have received sufficient information about the study and provided written informed consent.
3. Individuals who are able to safely participate in the BONE exercise program.
4. Individuals who are able to continuously participate in the once-weekly, 2-month BONE exercise program.
5. Individuals who are able to complete the scheduled assessments during the study period.
6. Individuals who are not regularly participating in the BONE program at the start of the study.

Key exclusion criteria

1. Individuals who have been advised by a physician to restrict physical exercise.
2. Individuals with severe cardiovascular, musculoskeletal, neurological, or other conditions that may prevent safe participation in the exercise program.
3. Individuals who are unable to continuously participate in the exercise program or complete the required assessments during the study period.
4. Individuals who are regularly participating in the BONE program at the start of the study.
5. Individuals who are considered unsuitable for participation by the principal investigator.

Target sample size

30

Name of lead principal investigator

1st name	Shiho
Middle name
Last name	Kurosaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8524

Address

1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan

TEL

082-424-6844

Email

shihok@hiroshima-u.ac.jp

Name of contact person

1st name	Shiho
Middle name
Last name	Kurosaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8524

Address

1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan

TEL

082-424-6844

Homepage URL

Email

shihok@hiroshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

Hiroshima University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

HiroshimaUniversity

Address

1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan

Tel

082-424-6844

Email

shihok@hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

18

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

Preinitiation

Date of protocol fixation

2026

Year

09

Month

18

Day

Date of IRB

2026

Year

05

Month

12

Day

Anticipated trial start date

2026

Year

09

Month

19

Day

Last follow-up date

2027

Year

03

Month

19

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

09

Month

18

Day

Last modified on

2026

Year

09

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072108