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Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of Bone loss in HIV-infected patients taking Highly Active Antiretroviral Therapy with Zoledronate
Scientific title
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)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-related osteopenia 290 0
HIV-related osteoporosis 291 0
Condition category
Condition code
Inflammatory and Immune System 326 326 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Musculoskeletal 327 327 0 0

Study type
Description of intervention(s) / exposure
4mg intravenous zoledronate given annually for 2 years compared with placebo. All participants will also take 50,000u calciferol monthly and 400mg calcium daily.
Intervention code [1] 222 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 381 0
The change in spine bone density over 2 years in the zoledronate-treated group compared to the change in the control group.
Timepoint [1] 381 0
Secondary outcome [1] 846 0
The change in hip bone density in the zoledronate-treated group compared to the change in the control group.
Timepoint [1] 846 0
Over 2 years.
Secondary outcome [2] 847 0
The change in bone turnover markers in the zoledronate-treated group compared to the change in the control group.
Timepoint [2] 847 0
Over 2 years.

Key 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.
Minimum age
Not stated
Maximum age
Not stated
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Medication was prepared by a nurse not involved with study participants. The medication was then administered by a study doctor who was unaware of the contents. All study personnel with patient contact were blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers in variable blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 142 0
New Zealand
State/province [1] 142 0

Funding & Sponsors
Funding source category [1] 385 0
Government body
Name [1] 385 0
Health Research Council of New Zealand
Address [1] 385 0
Country [1] 385 0
New Zealand
Primary sponsor type
Associate Professor A Grey
Secondary sponsor category [1] 314 0
Name [1] 314 0
University of Auckland Bone Research Group
Address [1] 314 0
Country [1] 314 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 1378 0
Auckland University
Ethics committee address [1] 1378 0
Ethics committee country [1] 1378 0
New Zealand
Date submitted for ethics approval [1] 1378 0
Approval date [1] 1378 0
Ethics approval number [1] 1378 0

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35463 0
Address 35463 0
Country 35463 0
Phone 35463 0
Fax 35463 0
Email 35463 0
Contact person for public queries
Name 9411 0
Anne Horne
Address 9411 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 9411 0
New Zealand
Phone 9411 0
+64 9 3078970
Fax 9411 0
+64 9 3737677
Email 9411 0
Contact person for scientific queries
Name 339 0
Associate Professor Andrew Grey
Address 339 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 339 0
New Zealand
Phone 339 0
+64 9 3737599
Fax 339 0
+64 9 3737677
Email 339 0