UMIN-ICDS Clinical Trial

Public title

Study of the Association Between Bone Mineral Density and Ultrasonographic Findings in Knee Osteoarthritis

Acronym

Knee OA-BMD Study

Scientific Title

Hip and Lumbar Spine Bone Mineral Density and Ultrasound-Quantified Structural Changes in Knee Osteoarthritis

Scientific Title:Acronym

US-BMD-KOA

Region

Japan

Condition

Knee osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the linear and nonlinear associations between hip and lumbar spine bone mineral density and ultrasound-quantified osteophyte height and joint space width in patients with knee osteoarthritis.

Basic objectives2

Others

Basic objectives -Others

To evaluate the association between bone mineral density and structural changes in knee osteoarthritis.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Association between hip and lumbar spine bone mineral density and total osteophyte height measured by ultrasonography.

Key secondary outcomes

Association with femoral osteophyte height measured by ultrasonography.
Association with tibial osteophyte height measured by ultrasonography.
Association with joint space width measured by ultrasonography.
Association between bone mineral density and radiographic severity based on the Kellgren-Lawrence grading system.

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

40

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients aged 20 years or older presenting with knee pain.
Patients who underwent standing knee radiography and knee ultrasonography.
Patients who underwent dual-energy X-ray absorptiometry (DXA) of the hip and lumbar spine within 90 days before or after ultrasonography.

Key exclusion criteria

Previous total knee arthroplasty.
Previous anterior cruciate ligament reconstruction.
Lateral compartment knee osteoarthritis.
Secondary osteoarthritis, including rheumatoid arthritis, gout, or calcium pyrophosphate deposition disease.
Spontaneous osteonecrosis of the medial femoral condyle.
Unavailable ultrasonography data.
Bone metastasis.
Refusal to participate in the study.

Target sample size

84

Name of lead principal investigator

1st name	Kiso
Middle name
Last name	Takeharu

Organization

Tachikawa Memorial Hospital

Division name

Department of Radiology

Zip code

309-1736

Address

2-12-14 Yakumo, Kasama, Ibaraki 309-1736, Japan

TEL

0296-77-7211

Email

rms5641@yahoo.co.jp

Name of contact person

1st name	KISO
Middle name
Last name	TAKEHARU

Organization

Tachikawa Memorial Hospital

Division name

Department of Radiology

Zip code

309-1736

Address

2-12-14 Yakumo, Kasama, Ibaraki 309-1736, Japan

TEL

0296-77-7211

Homepage URL

Email

rms5641@yahoo.co.jp

Institute

Tachikawa Memorial Hospital

Institute

Department

Personal name

Organization

No funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee, Tsukuba International University

Address

6-20-1 Manabe, Tsuchiura, Ibaraki 300-0051, Japan

Tel

029-826-6000

Email

s-kawata@tius.ac.jp

Secondary IDs

YES

Study ID_1

R08-7

Org. issuing International ID_1

Research Ethics Committee, Tsukuba International University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

25

Day

URL releasing protocol

Not publicly available

Publication of results

Unpublished

URL related to results and publications

Not publicly available

Number of participants that the trial has enrolled

84

Results

Among 84 participants and 127 knees, hip bone mineral density was not associated with radiographic knee osteoarthritis or Kellgren-Lawrence severity. Adjusted quadratic analyses showed inverse U-shaped associations of hip bone mineral density with total and femoral osteophyte height. Lumbar spine bone mineral density was positively associated with osteophyte height and negatively associated with joint space width.

Results date posted

2026

Year

07

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The analysis included 84 participants and 127 knees. The median age was 78.5 years, and 70 participants (83.3%) were women. The mean body mass index was 24.0 kg/m2, the mean hip bone mineral density was 0.69 g/cm2, and the mean lumbar spine bone mineral density was 1.03 g/cm2. Diabetes mellitus was present in 40.5% of participants. Based on the World Health Organization T-score classification, 11.9% had normal bone density, 51.2% had osteopenia, and 36.9% had osteoporosis.

Participant flow

A total of 689 patients comprising 872 knees who underwent knee radiography during the study period were screened. After the eligibility and exclusion criteria were applied, 382 patients comprising 491 knees remained potentially eligible. Of these, 128 knees had undergone dual-energy X-ray absorptiometry within 90 days before or after knee ultrasonography. One knee with bone metastasis was excluded, resulting in a final analysis population of 84 participants comprising 127 knees.

Adverse events

This was a retrospective observational study using existing clinical data. No study-specific intervention was performed, and no study-related adverse events occurred.

Outcome measures

The primary outcomes were the linear and nonlinear associations of hip and lumbar spine bone mineral density with ultrasonographically measured total, femoral, and tibial osteophyte height and joint space width. The secondary outcomes were the associations of bone mineral density with radiographic knee osteoarthritis and disease severity assessed using the Kellgren-Lawrence grade.

Plan to share IPD

Individual participant data will not be shared.

IPD sharing Plan description

The individual participant data used in this study contain clinical and imaging information. Owing to ethical restrictions and the need to protect participant privacy, the individual participant data will not be made publicly available. The sharing of aggregated study data may be considered upon reasonable request, subject to approval by the principal investigator and the relevant institutional review board.

Recruitment status

Completed

Date of protocol fixation

2022

Year

12

Month

01

Day

Date of IRB

2026

Year

05

Month

07

Day

Anticipated trial start date

2022

Year

12

Month

01

Day

Last follow-up date

2024

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This was a single-center retrospective cross-sectional observational study. Patients who underwent knee radiography, knee ultrasonography, and bone mineral density measurement between December 2022 and April 2024 were included. No intervention was performed. Existing clinical and imaging data were used to evaluate the associations between hip and lumbar spine bone mineral density and ultrasonographic osteophyte height and joint space width.

Registered date

2026

Year

07

Month

25

Day

Last modified on

2026

Year

07

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071331