Alendronate for Prevention of ART-associated bone loss (APART study)
Research type
Research Study
Full 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, HIV-1 infected subjects initiating antiretroviral therapy.
IRAS ID
230970
Contact name
Kings College Hospital R&D Department
Contact email
Sponsor organisation
University College Dublin
Eudract number
2014-004819-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 29 days
Research summary
This is a randomised trial of short course alendronate therapy or placebo (combined with vitamin D and calcium) to prevent bone loss in HIV positive persons initiating antiretroviral therapy. Previous studies have shown an increased risk of fracture and an increased prevalence of low bone mineral density (BMD) in people with HIV, and 2-6% reductions in BMD after initiating antiretroviral therapy.
In people with low BMD and osteoporosis, low BMD and risk of fracture can be attenuated with use of bisphosphonates (such as alendronate). In people with chronic HIV infection and low BMD, alendronate has been shown to increase BMD, generally safe and well tolerated. The role of bisphosphonates in limiting bone loss with ART initiation has not been widely studied.
This study aims to demonstrate if alendronate can prevent bone loss associated with the early stages of ART initiation. This is a novel, targeted use of bisphosphonates to limit specific effects of ART on bone.REC name
London - South East Research Ethics Committee
REC reference
18/LO/1481
Date of REC Opinion
16 Jan 2019
REC opinion
Further Information Favourable Opinion