Hepatitis B
Conditions
Interventions
The present study proposes to evaluate the effects of Tenofovir, compared to other nucleoside/nucleotide analogues (Entecavir and Lamivudine), on the bone mineral density of a group of patients with c
Drug
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Have a confirmed diagnosis of chronic hepatitis B; age greater than 18 years; being on Tenofovir for at least 12 months for group 1; being in use of Entecavir or Lamivudine for at least 12 months for group 2; have not made prior use of nucleoside / nucleotide analogues for group 3
Exclusion criteria
Exclusion criteria: Use of calcium and vitamin D supplements in the last month of inclusion in the study, as well as during the course of the study; liver cirrhosis score CHILD B or C; use of medications to treat osteoporosis; participants with previous thyroidectomy history; presence of chronic renal failure; concomitant HIV infection; concomitant hepatitis C virus infection; use of corticosteroids at doses greater than or equal to 1mg / kg body weight for more than 14 days of inclusion in the study, as well as during the course of the study; rheumatologic disease in activity; menopausal women or with secondary amenorrhea; women taking hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of changes in bone mineral density in patients with chronic hepatitis B using the antiretroviral Tenofovir. The changes will be verified from the bone densitometry examination, by the z-score classification of -1 to less than -2.50 and biochemical markers of bone formation and resorption. The examinations will be carried out in the second meeting with the patient, after the signing of the free and informed consent term (term of 15 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactAnderson Marliere Navarro
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed