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OpenTrials
Completed

NCT Number: NCT04535180

Sarcopenia and Osteoporosis in the Patients With Hemophilia

Hemophilia is a bleeding disorder and repeated joint bleeding leads to hemophilic arthropathy. Among patients with hemophilia, vitamin D deficiency and hemophilic arthropathy have been associated with osteoporosis in several clinical studies.There is no data on the prevalence of osteoporosis 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. This study will investigate the prevalence and corelation of sarcopenia and low BMD in patients with hemophilia.

patients in Taiwan. The study will estimate the prevalence of sarcopenia and body composition in the hemophilia population and compared baseline demographic and clinical characteristics between the non-sarcopenia and sarcopenia individuals, with particular emphasis on the overlap with osteoporosis and hemophilic arthropathy.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemophilia patients

Exclusion criteria

  • History of total hip arthroplasty
  • History of instrumentation in lumbar spine

Treatment and study plan

Dual-Energy X-ray Absorptiometry (DXA)

Diagnostic Test

Body composition will be measured using whole-body DXA (GE Lunar iDXA, GE Healthcare Lunar, Madison, Wisconsin, U.S.A.). Extremity skeletal muscle mass will be calculated using the values measured via the DXA; ASM will be calculated as the sum of skeletal muscle mass in the arms and legs, assuming that the mass of lean soft tissue is a skeletal muscle. Appendicular skeletal mass index (ASM/Ht2 ) will be determined as the sum of the arm and leg lean mass (kg)/height2 (m2

). BMD will be measured in lumbar spine and bilateral hip by the same DXA device (GE Lunar iDXA, GE Healthcare Lunar, Madison, Wisconsin, U.S.A.)

Primary outcomes

  1. Sacropenia

    Time frame: up to 4 weeks

    Extremity skeletal muscle mass will be calculated using the values measured via the DXA

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2020
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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