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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05517070
Other study ID # 1-108-05-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date February 28, 2023

Study information

Verified date August 2022
Source Tri-Service General Hospital
Contact Tsung Ying Li, Dr
Phone +886 287923311
Email doc31141@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Many clinical risk factors have been reported, such as hemophilic arthropathy, reduced physical activity, decreased sun exposure, hepatitis C virus infections, vitamin D deficiency, and low body mass index (BMI). There is no data on the prevalence of vitamin D deficiency and low BMD in hemophilia patients in Taiwan or Asia. To the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. The purpose of this study will evaluate the prevalence of vitamin D deficiency, low BMD, sarcopenia and body composition in a cohort of patients with hemophilia in Taiwan.


Description:

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Soucek et al. reported sarcopenia and low trabecular BMD at the radius in the boys with hemophilia by CT.The severity of hemophilic arthropathy associated with lower BMD, muscle atrophy and obesity has been shown by some studies. This is a single-center, cross-sectional, observational study. All participants will sign informed consent that fully disclosed the risks and benefits of study participation. The study will be performed at the Hemophilia Care and Research Center. Sixty adult patients (age ≥ 20) with hemophilia and 20 healthy subjects will be enrolled for scanning of the lean tissue, appendicular skeletal muscle mass (ASM), fat mass, lumbar spine and hip BMD by dual-energy X-ray absorptiometry (DXA) and assess serum vitamin D level. We will collect other clinically relevant information, including age, body mass index (BMI), hemophilia type and severity, inhibitor titer, Pettersson score by x-ray, HJHS, handgrip strength, history of HCV or HIV infection and history of fracture.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date February 28, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years and older
Eligibility Inclusion Criteria: - Hemophilia patients Exclusion Criteria: - Severe diseases affecting bone metabolism (such as primary hyperparathyroidism, hypogonadism), - History of total hip arthroplasty - History of instrumentation in lumbar spine

Study Design


Locations

Country Name City State
Taiwan Hemophilia care and research center Taipei

Sponsors (1)

Lead Sponsor Collaborator
Tsung-Ying Li

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vitamin D serum vitamin D one day
Secondary Bone marrow density Bone marrow density of lumbar spine and bilateral hip by dual X-ray absorptiometry (DXA) one day
Secondary Body composition using whole-body DXA (GE Lunar iDXA, GE Healthcare Lunar, Madison, Wisconsin, U.S.A.) one day
Secondary Pettersson score Bilateral shoulder, elbow, hip, knee, ankle joints score by x-ray. The Pettersson score ranges from 0 (normal) to 13 (most severe) and is according to the following eight radiographic features of joints: osteoporosis, osteophytes, narrowing of joint space, subchondral irregularity, subchondral cyst formation, erosion of joint margins, and bone remodelling. one day
Secondary Hemophilia Joint Health Score Functional and structured score of bilateral elbow, knee and ankle. The score for each joint is the sum of several elements including swelling (0-3), duration of swelling (0-1), muscle atrophy (0-2), crepitus of motion (0-2), flexion loss and extension loss (0-6), joint pain (0-2) and strength (0-4). A score of 20 may indicate the most severe damage/impairment in the evaluated joint and a score of zero corresponds to no identifiable joint impairment. one day
Secondary Handgrip strength Handgrip strength (kg) will be measured using the same standard calibrated hand dynamometers (Baseline® Hand Dynamometer - Digital LCD Gauge, Fabrication Enterprises Inc. White plains, New York, USA). We will calculate the mean of three maximal grip-strength measurement in each hand. one day
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