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Completed

NCT Number: NCT00948220

Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C

One single study has suggested that bone mineral density (BMD) is reduced in patients with non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard interferon and ribavirin may further decrease BMD. The aim of this study is to systematically investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Bone Diseases Bone Diseases, Metabolic Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ulm

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • proven chronic hepatitis C
  • aged between 18 and 65
  • male patients

Exclusion criteria

  • high grade liver fibrosis (Grade 3 - 4)
  • renal disease
  • hyperparathyroidism
  • hypogonadism
  • malignant disease
  • use of any other drug known to effect bone mineral metabolism
  • use of alcohol
  • organ transplant
  • any form of thyroid disease
  • any medical condition known to be associated with bone loss

Treatment and study plan

Peginterferon alfa-2a and ribavirin

Drug

standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d

Other names: Pegasys, Copegus

Primary outcomes

  1. Change of the bone mineral density of the lumbar spine and right hip measured by DEXA in patients with chronic hepatitis C with or without antiviral combination treatment with peginterferon and ribavirin

    Time frame: 96 weeks

Secondary outcomes

  1. Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.

    Time frame: 96 weeks

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Non-randomized Prospective Study on the Effect of Antiviral Therapy With Peginterferon Alfa-2a and Ribavirin on Bone Mineral Density and Metabolism in Patients With Chronic Viral Hepatitis C Genotype 1

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Jul 29, 2009
Registry last updated
Jun 7, 2011

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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