Clinical Trial: Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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, H

Brief 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 Summary:

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.

Sponsor: University College Dublin

Current Primary Outcome: Rate of changes in bone mineral density [ Time Frame: 50 weeks ]

Between-group differences in percentage change in total hip, lumbar spine, femoral neck BMD and body composition to week 50 among subjects who received at least one dose of the study medication


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of changes in bone turnover markers [ Time Frame: 50 weeks ]
    Between-group differences in percentage change in bone turnover markers
  • Impact of ART choice on alendronate protective effect [ Time Frame: 50 weeks ]
    Impact of choice of ART on changes in BMD and bone turnover markers


Original Secondary Outcome: Same as current

Information By: University College Dublin

Dates:
Date Received: December 17, 2014
Date Started: May 2016
Date Completion: October 2018
Last Updated: November 29, 2016
Last Verified: November 2016