Treatment with Zoledronic acid or Tenofovir Switching in HIV-Infected

Bisphosphonate Therapy with Zoledronic acid or Tenofovir Switching to Improve Low Bone Mineral Density in HIV-Infected Adults

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003359-39-ES

Enrollment

Registered

2014-01-16

Start date

2014-01-14

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

low bone mineral density - HIV MedDRA version: 16.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862

Interventions

Trade Name: Aclasta Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072-93-8 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. provision of written, informed consent 2. HIV infected adult ?18 years of age 3. stable and well-tolerated ART including tenofovir for the preceding 6 months 4. plasma HIV RNA 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

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 (total testosterone/oestrogen 25% above upper normal limit); hypothyroidism (low T4 and elevated TSH); hyperparathyroidism (elevated parathyroid hormone); inhaled fluticasone in a patient receiving ritonavir; prednisolone ?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 (defined above), 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effects of zoledronic acid 5 mg IV yearly to switching from tenofovir to another antiretroviral drug on lumbar spine BMD (primary endpoint) over 2 years.;Secondary Objective: To compare the randomised groups for: 1. other bone parameters - mean percent change in hip BMD - incidence of osteoporosis (T-score -1 at hip and spine) - fracture risk estimated with the Australian version of the FRAX equation48 - serum levels of CTx and P1NP - fractures (except of the skull, and of the small bones of the hands and feet) 2. safety (clinical adverse events [all grades]; all serious adverse events; AIDS; death; use of concomitant medications for toxicity; estimated glomerular filtration rate (eGFR, by MDRD equation; laboratory adverse events; virological failure (FDA definition: plasma HIV RNA >400 copies/mL on 2 consecutive occasions ?4 weeks apart) 3. modifications to ART (after baseline);Primary end point(s): mean percent change at the lumbar spine at 2 yeras;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To compare the effects of zoledronic acid 5 mg IV yearly to switching from tenofovir to another antiretroviral drug on lumbar spine BMD (primary endpoint) over 2 years.;Secondary Objective: To compare the randomised groups for: 1. other bone parameters - mean percent change in hip BMD - incidence of osteoporosis (T-score -1 at hip and spine) - fracture risk estimated with the Australian version of the FRAX equation48 - serum levels of CTx and P1NP - fractures (except of the skull, and of the small bones of the hands and feet) 2. safety (clinical adverse events [all grades]; all serious adverse events; AIDS; death; use of concomitant medications for toxicity; estimated glomerular filtration rate (eGFR, by MDRD equation; laboratory adverse events; virological failure (FDA definition: plasma HIV RNA >400 copies/mL on 2 consecutive occasions ?4 weeks apart) 3. modifications to ART (after baseline);Primary end point(s): mean percent change at the lumbar spine at 2 yeras;Timepoint(s) of evaluation of this end point: 2 years

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Secondary

Measure	Time frame
Secondary end point(s): - mean percent change in hip BMD - incidence of osteoporosis (T-score -1 at hip and spine) - fracture risk estimated with the Australian version of the FRAX equation48 - serum levels of CTx and P1NP - fractures (except of the skull, and of the small bones of the hands and feet) 2. safety (clinical adverse events [all grades]; all serious adverse events; AIDS; death; use of concomitant medications for toxicity; estimated glomerular filtration rate (eGFR, by MDRD equation; laboratory adverse events; virological failure (FDA definition: plasma HIV RNA >400 copies/mL on 2 consecutive occasions ?4 weeks apart) 3. modifications to ART (after baseline);Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Secondary end point(s): - mean percent change in hip BMD - incidence of osteoporosis (T-score -1 at hip and spine) - fracture risk estimated with the Australian version of the FRAX equation48 - serum levels of CTx and P1NP - fractures (except of the skull, and of the small bones of the hands and feet) 2. safety (clinical adverse events [all grades]; all serious adverse events; AIDS; death; use of concomitant medications for toxicity; estimated glomerular filtration rate (eGFR, by MDRD equation; laboratory adverse events; virological failure (FDA definition: plasma HIV RNA >400 copies/mL on 2 consecutive occasions ?4 weeks apart) 3. modifications to ART (after baseline);Timepoint(s) of evaluation of this end point: 2 years

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Countries

Australia, Spain

Contacts

Public ContactJoan Albert Arnaiz

CTU (Clinical Trials Unit)

jaarnaiz@clinic.ub.es34932279838

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026