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Trial registered on ANZCTR


Registration number
ACTRN12605000208606
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
25/08/2005
Date last updated
25/11/2019
Date data sharing statement initially provided
15/11/2019
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
Osteoporosis

Intervention/exposure
Study type
Interventional
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
Placebo
Control group
Placebo

Outcomes
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.

Eligibility
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
Sex
Males
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2003
Actual
5/02/2003
Date of last participant enrolment
Anticipated
Actual
17/03/2004
Date of last data collection
Anticipated
Actual
16/08/2016
Sample size
Target
70
Accrual to date
Final
43
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
Country [1] 385 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor A Grey
Address
Country
Secondary sponsor category [1] 314 0
University
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
Approved
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
07/11/2002
Ethics approval number [1] 1378 0

Summary
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
1. Bolland MJ, Horne AM, Briggs SE, Thomas MG, Reid IR, Gamble GD, Grey A. Long-Term Stable Bone Mineral Density in HIV-Infected Men Without Risk Factors for Osteoporosis Treated with Antiretroviral Therapy. Calcif Tissue Int 2019;105:423-429.
2. Bolland MJ, Horne AM, Briggs SE, Thomas MG, Reid I, Gamble GD, Grey A. Effects of Intravenous Zoledronate on Bone Turnover and Bone Density Persist for at Least 11 Years in HIV-Infected Men. J Bone Miner Res 2019;34:1248-1253.
3. Bolland MJ, Grey A, Horne AM, Briggs SE, Thomas MG, Ellis-Pegler RB, Gamble GD, Reid IR. Effects of Intravenous Zoledronate on Bone Turnover and Bone Density Persist for at Least Five Years in HIV-Infected Men. J Clin Endocrinol Metab 2012;97:1922-8.
4. Bolland MJ, Grey A, Horne AM, Briggs SE, Thomas MG, Ellis-Pegler RB, Gamble GD, Reid IR. Stable bone mineral density over 6 years in HIV-infected men treated with highly active antiretroviral therapy (HAART). Clin Endocrinol (Oxf) 2012;76:643-8.
5. Bolland MJ, Grey A, Horne AM, Thomas MG. Osteomalacia in an HIV-infected man receiving rifabutin, a cytochrome P450 enzyme inducer: a case report. Ann Clin Microbiol Antimicrob 2008;7:3.
6. Bolland MJ, Grey AB, Horne AM, Briggs SE, Thomas MG, Ellis-Pegler RB, Woodhouse AF, Gamble GD, Reid IR. Bone mineral density remains stable in HAART-treated HIV-infected men over 2 years. Clin Endocrinol (Oxf) 2007;67:270-5.
7. Bolland MJ, Grey AB, Horne AM, Briggs SE, Thomas MG, Ellis-Pegler RB, Woodhouse AF, Gamble GD, Reid IR. Bone mineral density is not reduced in HIV-infected Caucasian men treated with highly active antiretroviral therapy. Clin Endocrinol (Oxf) 2006;65:191-7.
Public notes

Contacts
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
[email protected]
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.