Sarcopenia and Osteoporosis in the Patients With Hemophilia

August 29, 2020 updated by: Tsung-Ying Li, Tri-Service General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemophilia adult patients

Description

Inclusion Criteria:

  • Hemophilia patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemophilia
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sacropenia
Time Frame: up to 4 weeks
Extremity skeletal muscle mass will be calculated using the values measured via the DXA
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 29, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-107-05-053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemophilia

Clinical Trials on Dual-energy X-ray absorptiometry (DXA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe