Bisphosphonate Therapy with Zoledronic acid or Tenofovir Switching to Improve Low Bone Mineral Density in HIV-Infected Adults: a Strategic, Randomised Trial

Phase 4

Completed

• Conditions: HIV; osteopenia; Inflammatory and Immune System - Other inflammatory or immune system disorders; Musculoskeletal - Osteoporosis; Infection - Acquired immune deficiency syndrome (AIDS / HIV)

• Registration Number: ACTRN12612000776808
• Lead Sponsor: St Vincents Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. provision of written, informed consent
2. HIV infected adult equal to or greater than 18 years of age
3. stable and well-tolerated ART including tenofovir for the preceding 6 months
4. plasma HIV RNA <50 copies/ml for at least the preceding 3 months
5. eGFR >60ml/min (patients at higher risk of zoledronic acid/tenofovir nephrotoxicity)
6. spine or neck of femur T score = -1.0 measured by DXA (i.e. osteopenia)

Exclusion Criteria

1. prior bisphosphonate therapy
2. use of tenofovir for previously active chronic hepatitis B co-infection
3. requiring therapy for low BMD (e.g. prior fragility fracture; other metabolic bone disease)
4. other secondary causes of osteoporosis: hypogonadism (low total testosterone/oestrogen and luteinizing hormone >25% above upper normal limit); hypothyroidism (low T4 and elevated TSH); hyperparathyroidism (elevated parathyroid hormone); inhaled fluticasone in a patient receiving ritonavir; prednisolone equal to or greater than 7.5mg/d or equivalent
5. contra-indications to zoledronic acid (known hypersensitivity to bisphosphonates, hypocalcaemia, prior or current uveitis, eGFR<35 mL/min)
6. recent (within the last 2 months) or planned dental surgery (at investigators discretion)
7. previous virological failure, genotypic resistance, intolerance or contraindication to proposed switch antiretroviral drug
8. HLA-B*5701 positive (abacavir contra-indicated) or prior ischaemic cardiovascular disease if planning to switch from tenofovir to abacavir
9. concurrent use of any nephrotoxic drug
10. breast-feeding or pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the effects of zoledronic acid 5 mg IV yearly to switching from tenofovir to another antiretroviral drug on lumbar spine BMD measured by Dual-energy X-ray absorptiometry [DEXA] scanning[2 years];the effects of zoledronic acid 5 mg IV yearly to switching from tenofovir to another antiretroviral drug on hip BMD measured by Dual-energy X-ray absorptiometry [DEXA] scanning[2 years]