Prevention of Bone loss in HIV-infected patients taking Highly Active Antiretroviral Therapy with Zoledronate

A two year double blind, randomised, controlled trial to evaluate the efficacy of zoledronic acid in the prevention of bone loss in patients infected with human immunodeficiency virus taking highly active antiretroviral therapy (HAART)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000208606

Enrollment

Registered

2005-08-25

Start date

2003-02-05

Completion date

2004-03-17

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a 2 year study designed to determine whether the use of an annual dose of zoledronate prevents bone loss associated with HIV infection

Interventions

4mg intravenous zoledronate given annually for 2 years compared with placebo. All participants will also take 50,000u calciferol monthly and 400mg calcium daily.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

HIV positive and have taken HAART for at least 3 months and have a bone mineral density T score of less than -0.5SD at any site.

Exclusion criteria

Renal impairment (serum creatinine >0.15 mmol/L), untreated hypothyroidism or hyperthyroidism, chronic liver disease, concurrent major systemic illness, including malignancy, active major gastrointestinal disease, metabolic bone diseases, primary hyperparathyroidism, more than 2 hospital admissions within 6 months of study entry, use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding six months.

Outcome results