Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has already been proved.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

Inclusion Criteria:

1. 18 years old or elder.

2. Documented HIV-1 infection, with or without antiretroviral treatment.

3. 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)

4. Willing to follow the study protocol.

5. Informed Consent signature.

Exclusion Criteria:

1. In women, pregnancy or breastfeeding.

2. Other possible causes of secondary osteoporosis.

3. Creatinin over 2.3mg/mL

4. Glomerular filter less than 50 mL/min (estimated through MDRD)

5. Alendronate treatment in the last 6 months.