UMIN-ICDS Clinical Trial

Public title

Bone Health and Muscle Mass: What's the Connection in Older Women?

Acronym

BONEMUS (BONe health and musclE Mass in older wOmen Study)

Scientific Title

Relationship between sarcopenia indices and BMD variables in healthy community-dwelling older women

Scientific Title:Acronym

WISDOM (Women's Indices of Sarcopenia and Density of bOne Measurement)

Region

Asia(except Japan)

Condition

The study focuses on sarcopenia and osteoporosis in healthy community-dwelling older women.

Classification by specialty

Endocrinology and Metabolism	Geriatrics	Orthopedics
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. To investigate the association between sarcopenia indices and bone mineral density (BMD) values using dual-energy X-ray absorptiometry (DXA) in healthy older women.
2. To examine the proper threshold of sarcopenia-related indices in healthy older women.

Basic objectives2

Others

Basic objectives -Others

1. To assess the differences in sarcopenia indices (HGS, 6MWS, and SMI) between participants with normal BMD and those with osteopenia or osteoporosis.
2. To evaluate the prevalence of osteoporosis and sarcopenia in the study population of community-dwelling healthy postmenopausal women aged over 50.
3. To investigate the relationship between muscle mass (as measured by SMI) and BMD, in addition to the relationship between muscle function (HGS and 6MWS) and BMD.
4. To explore the potential of using sarcopenia indices as screening tools for low bone mass in relatively healthy older women before they are diagnosed with sarcopenia.
5. To contribute to the understanding of the muscle-bone relationship in the context of aging, particularly in women who have not yet developed sarcopenia.
6. To examine the potential differences in the relationship between sarcopenia indices and BMD at different skeletal sites (lumbar spine vs. femoral neck).

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. The relationship between hand-grip strength (HGS) and BMD values of the lumbar spine (LS) and femoral neck (FN).
2. The association between 6-minute walking speed (6MWS) and BMD values of the LS and FN.
3. The correlation between skeletal muscle index (SMI) and BMD values.
4. Determination of cutoff values for HGS and 6MWS to predict osteopenia or osteoporosis in the LS and FN.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

Not applicable

Gender

Female

Key inclusion criteria

1. Community-dwelling postmenopausal women
2. Aged over 50 years
3. Voluntarily participated in the study
4. Active daily life with routine walking
5. Clinical frailty scale of one or two

Key exclusion criteria

1.Underlying diseases with potential to influence BMD status, such as:

a. Thyroid dysfunction
b. Rheumatic disease
c. Diabetes (uncontrolled)
d. History of any malignancy


Note: Subjects with well-controlled hypertension, diabetes mellitus, or benign nonfunctioning thyroid nodules were not excluded.

Target sample size

86

Name of lead principal investigator

1st name	Myung-Jun
Middle name
Last name	Shin

Organization

Pusan National University Hospital, Pusan National University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

49241

Address

179, Gudeok-Ro, Seo-Gu, Busan

TEL

82-51-240-7071

Email

jpark@pnuh.co.kr

Name of contact person

1st name	Jong-Hwan
Middle name
Last name	Park

Organization

Pusan National University Hospital

Division name

Health Convergence Medicine Laboratory, Biomedical Research Institute

Zip code

49241

Address

179, Gudeok-Ro, Seo-Gu, Busan

TEL

82-51-240-7071

Homepage URL

Email

parkj@pusan.ac.kr

Institute

Pusan National University Hospital

Institute

Department

Personal name

Organization

Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Pusan National University Hospital Institutional Review Board

Address

179, Gudeok-Ro, Seo-Gu, Busan

Tel

82-51-240-7257

Email

services@pusan.ac.kr

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

2024

Year

07

Month

24

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/ctr_e/ctr_reg_rec.cgi

Publication of results

Unpublished

URL related to results and publications

https://center6.umin.ac.jp/cgi-bin/ctr_e/ctr_reg_rec.cgi

Number of participants that the trial has enrolled

86

Results

The study found significant correlations between hand grip strength (HGS) and bone mineral density (BMD) at both lumbar spine and femoral neck. The 6-minute walking speed (6MWS) was significantly associated only with femoral neck BMD.

Results date posted

2024

Year

07

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Community-dwelling postmenopausal women.
Aged over 50 (median 66.5 years).
Median BMI: 24.2 kg/m2.

Participant flow

all 86 enrolled participants seem to have completed the study.

Adverse events

(This was an observational study, not an interventional trial.

Outcome measures

Primary: Relationship between sarcopenia indices (HGS, 6MWS, SMI) and BMD values.
Secondary: Cutoff values for HGS and 6MWS to predict osteopenia or osteoporosis.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

05

Month

20

Day

Date of IRB

2019

Year

05

Month

20

Day

Anticipated trial start date

2019

Year

05

Month

20

Day

Last follow-up date

2021

Year

07

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Study design: Cross-sectional observational study

2. Participants:
- 86 community-dwelling postmenopausal women
- Aged over 50 years (median age 66.5 years, IQR: 60-73 years)

3. Main measurements:
a) Body composition and Bone Mineral Density (BMD):
- Measured using Dual-energy X-ray Absorptiometry (DXA)
- BMD measured at Lumbar Spine (LS) and Femoral Neck (FN)
- Skeletal Muscle Index (SMI) calculated

b) Muscle strength:
- Measured by Hand Grip Strength (HGS) using a Jamar hand dynamometer

c) Physical performance:
- Measured by 6-Minute Walking Speed (6MWS)

4. Key observations:
- Relationship between sarcopenia indices (HGS, 6MWS, SMI) and BMD values
- Differences in sarcopenia indices between participants with normal BMD and those with osteopenia or osteoporosis
- Correlation between muscle strength, physical performance, and BMD
- Determination of cutoff values for HGS and 6MWS to predict osteopenia or osteoporosis

5. Duration of observation:
- Single time point assessment for each participant (cross-sectional design)
- Overall study period: May 20, 2019 to December 31, 2021

6. Sample size:
- Target sample size was 70
- Actual enrolled participants were 86 according to the English manuscript

This study aimed to investigate the relationship between sarcopenia indices and bone mineral density in healthy older women, focusing on muscle strength and physical performance as potential indicators of bone health.

Registered date

2024

Year

07

Month

24

Day

Last modified on

2024

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062891