Status:
COMPLETED
Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The purpose of this project is to determine the incidence of osteoporosis in the investigators' population of HIV-infected patients and to assess the efficacy and security of zoledronic acid, whose ef...
Detailed Description
The lower bone mineral density that has been described in patients with HIV-infection has not meant an increase of long term complications. Nevertheless, it could involve an increase if the associated...
Eligibility Criteria
Inclusion
- 18 years old or older.
- Documented HIV-1 infection, with or without antiretroviral treatment.
- Presence of WHO osteoporosis criteria, defined as t-score under -2.5 in lumbar, hip and/or trochanter (DEXA in the last 6 months is needed).
- Willing to follow the study protocol.
- Informed Consent signature.
Exclusion
- In women, pregnancy or breastfeeding.
- Other possible causes of secondary osteoporosis.
- Creatinine over 2.3 mg/mL.
- Glomerular filter less than 50 mL/min (estimated through MDRD).
- Treatment for Osteoporosis in the last 4 months.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00795483
Start Date
November 1 2009
End Date
November 1 2011
Last Update
January 31 2020
Active Locations (1)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916