Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

HIV Infections Clinical Trial

Official title:

Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795483
• Other study ID #: VIH-ZOL
• Status: Completed
• Phase: Phase 4
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 efficacy in post-menopausal women with high fracture risk treatment and in Paget's disease treatment has already been demonstrated.

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 co-morbidity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That is why it is necessary to know the real prevalence of osteoporosis in this population of patients so the real dimensions of the problems can be defined.

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of zoledronic acid. If the annual use of endovenous zoledronic acid obtains equivalent results to those obtained with oral and weekly alendronate in other studies with the same population, its use would be justified because of its posology benefits. The annual administration can improve compliance in patients who are receiving a big quantity of drugs, as HIV-infected patients do, and who probably have to be treated for life. Moreover, its elimination is renal so there is absence of interactions with antiretroviral drugs what makes of zoledronic acid a very promising alternative. Finally, there is no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bisphosphonates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. 18 years old or older.

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. Creatinine over 2.3 mg/mL.

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

5. Treatment for Osteoporosis in the last 4 months.

Related Conditions & MeSH terms

• HIV Infections
• Osteoporosis

Intervention

Drug:
• Zoledronic acid
Zoledronic Acid 5mg/year

Behavioral:
• Lifestyle modifications
Lifestyle modifications

Drug:
• Zoledronic acid
Zoledronic acid (5mg/2years)

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density		Evolution from baseline to week 48
Primary	Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density		Evolution from baseline to week 96
Secondary	Adverse events		From baseline to week 96
Secondary	Lab tests		Evolution from baseline to week 96
Secondary	Related clinical events (bone fractures)		From baseline to week 96
Secondary	Osteoblastic/Osteoclastic activity, bone formation/reabsorption.		Evolution from baseline to week 48
Secondary	Osteoblastic/Osteoclastic activity, bone formation/reabsorption.		Evolution from baseline to week 96