UMIN-CTR Clinical Trial

Public title

Effects of a low-load, bone-focused exercise (OSTEO) program on bone properties in older women

Acronym

OSTEO-Older Women Study

Scientific Title

Effects of a Low-Load, Bone-Focused Exercise Program (OSTEO) on Bone Mineral Density and Quantitative Ultrasound Parameters in Older Women

Scientific Title:Acronym

OSTEO-Bone

Region

Japan

Condition

Age-related bone loss (risk of osteoporosis)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of the present study was to investigate the effects of a 12-week OSTEO program on bone mineral density of the femoral neck and lumbar spine assessed by dual-energy X-ray absorptiometry, as well as to evaluate changes in calcaneal quantitative ultrasound parameters, in community-dwelling postmenopausal women.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Femoral neck bone mineral density, lumbar spine bone mineral density, calcaneal quantitative ultrasound speed of sound

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Participants in the intervention group performed a low-load, bone-focused exercise program (OSTEO) for 12 weeks. Sessions were held once weekly for 60 minutes under the supervision of trained instructors. Each session consisted of a 45-minute seated component (three 15-minute blocks) and a 15-minute standing component. The seated component sequentially focused on (1) the feet and lower limb alignment, (2) the knees, hips, and lumbar spine, and (3) the ribs and shoulder girdle. The standing component emphasized whole-body skeletal integration centered on the spine and was performed with rhythmic music. Exercise intensity was set using the Borg 6-20 Rating of Perceived Exertion scale: 9-12 for seated exercises and 12-14 for standing exercises. All exercises were performed barefoot, and attendance was recorded for each session.

Interventions/Control_2

Participants in the control group received no specific exercise intervention and were instructed to maintain their usual daily activities during the study period.

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

68

years-old

<=

Age-upper limit

78

years-old

>=

Gender

Female

Key inclusion criteria

Community-dwelling older women who were able to perform activities of daily living independently and provided written informed consent to participate in the study.

Key exclusion criteria

Individuals with medical conditions or treatments known to substantially affect bone metabolism, or those with contraindications to exercise identified during medical screening.

Target sample size

22

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, Higashihiroshima-shi, Hiroshima, 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, Higashihiroshima-shi, Hiroshima, Japan

TEL

082-424-6844

Homepage URL

Email

shihok@hirshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

Hiroshima University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Humanities and Social Sciences, Hiroshima University

Address

1-1-1 Kagamiyama, Higashihiroshima-shi, Hiroshima, 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

01

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

22

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

No longer recruiting

Date of protocol fixation

2025

Year

11

Month

28

Day

Date of IRB

2025

Year

11

Month

27

Day

Anticipated trial start date

2025

Year

12

Month

01

Day

Last follow-up date

2026

Year

02

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

01

Month

20

Day

Last modified on

2026

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069106