Sarcopenia and Osteoporosis in the Patients With Hemophilia

Sarcopenia Clinical Trial

Official title:

Sarcopenia and Osteoporosis in the Patients With Hemophilia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535180
• Other study ID #: 1-107-05-053
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Hemophilia patients

Exclusion Criteria:

• History of total hip arthroplasty

• History of instrumentation in lumbar spine

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Hemophilia
• Hemophilia A
• Hemophilic Arthropathy
• Joint Diseases
• Osteoporosis
• Osteoporosis, Osteopenia
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sacropenia	Extremity skeletal muscle mass will be calculated using the values measured via the DXA	up to 4 weeks