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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1-ANNUAL

1\. Zoledronic acid + Lifestyle modifications (experimental)

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Zoledronic Acid 5mg/year

Lifestyle modifications

Intervention Type BEHAVIORAL

Lifestyle modifications

2-CONTROL

2\. Lifestyle modifications (control)

Group Type OTHER

Lifestyle modifications

Intervention Type BEHAVIORAL

Lifestyle modifications

3-BIENNIAL

3\. Zoledronic acid + Lifestyle modifications (experimental)

Group Type EXPERIMENTAL

Lifestyle modifications

Intervention Type BEHAVIORAL

Lifestyle modifications

Zoledronic acid

Intervention Type DRUG

Zoledronic acid (5mg/2years)

Interventions

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Zoledronic acid

Zoledronic Acid 5mg/year

Intervention Type DRUG

Lifestyle modifications

Intervention Type BEHAVIORAL

Zoledronic acid

Zoledronic acid (5mg/2years)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No