UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058939 |
|---|---|
| Receipt number | R000067332 |
| Scientific Title | Prospective and Retrospective Research for the Diagnosis of Osteoporosis: Validation and Establishment of Vertebral Hounsfield Unit |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/08/30 16:19:51 |
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Basic information
Public title
Prospective and Retrospective Research for the Diagnosis of Osteoporosis: Validation and Establishment of Vertebral Hounsfield Unit
Acronym
HU-PROVE study
Scientific Title
Prospective and Retrospective Research for the Diagnosis of Osteoporosis: Validation and Establishment of Vertebral Hounsfield Unit
Scientific Title:Acronym
HU-PROVE study
Region
| Japan |
Condition
Condition
Ostoporosis
Classification by specialty
| Medicine in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, following the same approach used when establishing the DXA reference values (Looker A et al. Osteoporosis International 1998), bone mineral density in young adults (20 - 44 years) is calculated and used as the reference, with osteoporosis defined as -2.5 SD or below and osteopenia as between -2.5 and -1 SD. Furthermore, by prospectively following patients with lumbar CT data for four years and evaluating their fracture risk, we aim to validate the appropriateness of the cutoff values determined from these reference standards.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calculate the reference values of bone mineral density.
Compare the incidence of vertebral fractures according to the presence or absence of osteoporosis.
Key secondary outcomes
Non-vertebral fractures (proximal humerus, proximal femur, pelvis)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection Criteria 1
Patients aged 20-44 years at the time of lumbar CT imaging.
Patients with CT scans that include the lumbar spine between L1-4.
Selection Criteria 2
Patients aged 50 years or older at the time of lumbar CT imaging for lumbar disease diagnosis.
Patients who underwent CT examinations including the lumbar spine between L1-L4.
Patients with DXA data obtained within 6 months of the lumbar CT imaging date at the time of lumbar disease diagnosis.
Patients with spinal X-rays available at the 2-year point within 6 months and 4-year point within 1 year from the lumbar CT imaging date at the time of lumbar disease diagnosis.
Key exclusion criteria
Patients suspected of having scoliosis 10 or more degrees or secondary osteoporosis such as long-term steroid use, hyperparathyroidism, hyperthyroidism, hypogonadism, Cushing syndrome, diabetes, chronic kidney disease, chronic obstructive pulmonary disease, etc.
Patients who have undergone spinal fusion surgery.
Patients suspected of having infection or tumor.
Target sample size
2800
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Takahashi |
Organization
Osaka Metropolitan University
Division name
Orthopaedic Surgery
Zip code
5458585
Address
1-4-3 Asahimachi, Abenoku, Osaka city
TEL
06-6645-3851
stakahashi@omu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Taniwaki |
Organization
Osaka Metropolitan University
Division name
Orthopaedic Surgery
Zip code
5458585
Address
1-4-3 Asahimachi, Abenoku, Osaka city
TEL
06-6645-3851
Homepage URL
tanishi517@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-2-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 30 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Establishing Reference Values in Young Adults (20-44 years)
Cross-sectional study
The following items are routinely collected in daily clinical practice.
(In this study, information will be collected from April 2010 until the date of research approval by the head of the institution.)
Patient demographics: age, sex, diagnosis, medical history (rheumatoid arthritis, steroid use, secondary osteoporosis, renal failure, diabetes mellitus)
Physical findings: height, weight
Imaging: lumbar CT
Observation and examination schedule (for young adults):
Time point Patient demographics & physical findings Lumbar CT (L1-L4)
At diagnosis of lumbar disease / CT imaging date
2 years
4 years
2. Verification of the Impact of Osteoporosis (HU-based) in Spinal Patients
Prospective and retrospective longitudinal study
The following items are routinely collected in daily clinical practice.
(In this study, information will be collected from April 2010 to March 2029.)
Patient demographics: age, sex, diagnosis, medical history (rheumatoid arthritis, steroid use, secondary osteoporosis, renal failure, diabetes mellitus), family history (parental history of proximal femoral fracture), lifestyle history (smoking, alcohol consumption 3 or more units/day)
Physical findings: height, weight
Imaging: DXA, spinal radiographs, lumbar CT
Other: fracture information, medication history for osteoporosis treatment
Management information
Registered date
| 2025 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067332
