NCT02322099

Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

A Multi-centre, Prospective, Randomised Trial of Short Course Alendronate Therapy or Placebo Combined With Vitamin D and Calcium to Prevent Loss of Bone Mineral Density in Antiretroviral-naïve, HIV-1 Infected Subjects Initiating Antiretroviral Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral density (BMD), characterised by increases in bone turnover, which is largely limited to the first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone turnover and can limit loss of bone mineral density. This study aims to determine if a short course of treatment with the oral bisphosphonate alendronate can limit loss of bone mineral density associated with initiation of ART in HIV-1 infected, antiretroviral naive, adult subjects.

Detailed description

Multi-centre, prospective, randomised, double-blind, placebo-controlled trial over 50 weeks. The aims of this study include: 1. To determine if short-course treatment with alendronate versus placebo combined with calcium and vitamin D, initiated 2 weeks prior to start of ART and can prevent loss of BMD over 48 weeks of follow-up post ART initiation. 2. To explore the effect of alendronate on bone turnover in the setting of ART initiation. 3. To determine which factors, such as choice of ART, impacts the protective effect of alendronate in preventing BMD loss. 4. To determine the relationship between changes in bone turnover markers, vitamin D, parathyroid hormone and calcium levels. 5. To explore the pathogenesis of BMD loss with initiation of ART by investigating relationships between changes in immune function (T-cells and B-cells subsets), bone turnover and BMD.

Conditions

• Bone Demineralization

Interventions

Type	Name	Description
DRUG	Alendronate	alendronate 70 mg tablets to be administered weekly for a total of 14 weeks, commencing 2 weeks prior to ART initiation
DRUG	Placebo	Sugar pill manufactured to mimic alendronate 70 mg tablet administered weekly for a total of 14 weeks, commencing 2 weeks prior to ART
DIETARY_SUPPLEMENT	calcium carbonate and colecalciferol	Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) and colecalciferol 400 iu (equivalent to 10 micrograms of vitamin D3) tablets administered twice daily for a total of 14 weeks, commencing 2 weeks prior to ART initiation
DRUG	Tenofovir disoproxil	Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label) commencing 2 weeks after alendronate initiation and continuing for 48 weeks

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2014-12-22
• Last updated: 2022-05-26

Locations

2 sites across 1 country: Ireland