Sarcopenia and Osteoporosis in the Patients With Hemophilia

NCT04535180 | Completed

• 1 other identifier: 1-107-05-053
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Hemophilia; Osteoporosis, Osteopenia; Hemophilic Arthropathy

Outcome Measures

Primary Outcomes (1)

• Sacropenia

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

  up to 4 weeks

Study Arms (1)

Hemophilia

Diagnostic Test: Dual-energy X-ray absorptiometry (DXA)

Interventions

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.)

Hemophilia

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemophilia adult patients

You may qualify if:

• Hemophilia patients

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia; Hemophilia A; Osteoporosis; Bone Diseases, Metabolic

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: September 1, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

TW (1)