Hepatitis C, ChronicPhase 4NCT00948220
Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C
A Phase 4 study testing peginterferon alfa-2a and ribavirin in people with Hepatitis C, Chronic and Liver Diseases, run by University of Ulm at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases
- What is being tested?
- peginterferon alfa-2a and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2003to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proven chronic hepatitis C
- aged between 18 and 65
- male patients
Who cannot join
- high grade liver fibrosis (Grade 3 - 4)
- renal disease
- hyperparathyroidism
- hypogonadism
- malignant disease
- use of any other drug known to effect bone mineral metabolism
Show all 10Show fewer
- use of alcohol
- organ transplant
- any form of thyroid disease
- any medical condition known to be associated with bone loss
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases
- Being tested
- peginterferon alfa-2a and ribavirin
- Keywords
- HCV, hepatitis C virus, CHC, chronic hepatitis c, interferon, ribavirin, DEXA, BMD, bone mineral density, osteoporosis, osteopenia, osteodystrophy, osteodensitometry, Bone Density, Hepatitis, Viral, Human, Anti-Infective Agents, peginterferon alfa-2a
- Medical subject headings
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Hepatitis C, Osteoporosis, Bone Diseases, Metabolic, Hepatitis, Viral, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon alfa-2a and ribavirinDrug
Also called Pegasys, Copegus
standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin Receives: Drug: peginterferon alfa-2a and ribavirin |
| Control | No intervention | Chronic hepatitis C patients without standard antiviral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 96 weeks
Secondary outcomes (1)
Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJul 2003
- Primary completionJan 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Michael Fuchs, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948220
- Sponsor's protocol ID
- OSTEO
- Status last verified
- May 2011
- First submitted
- 24 Jul 2009
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00948220
- Acronym / sponsor ID
- OSTEO
- Conditions
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases
- Keywords
- HCV, hepatitis C virus, CHC, chronic hepatitis c, interferon, ribavirin, DEXA, BMD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jul 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: peginterferon alfa-2a and ribavirinChronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin |
| Control | No intervention | –Chronic hepatitis C patients without standard antiviral therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- proven chronic hepatitis C
- aged between 18 and 65
- male patients
Key exclusion criteria (10 listed)
- high grade liver fibrosis (Grade 3 - 4)
- renal disease
- hyperparathyroidism
- hypogonadism
- malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon alfa-2a and ribavirinAlso: Pegasys, Copegusstandard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d | Drug | Treatment |
Primary outcome
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
1 secondary outcome
Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.
Time frame: 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fuchs, MD principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing peginterferon alfa-2a and ribavirin in people with Hepatitis C, Chronic and Liver Diseases, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2011.