Alendronate for Prevention of AntiRetroviral Therapy-associated bone loss (APART study)

Over six thousand people have been diagnosed with HIV infection in Ireland. People living with HIV are now living longer because of effective therapy. However, therapy is life-long and is associated with significant side effects. In addition, immune damage induced by HIV persists even with effective therapy. As a result, people with HIV experience higher than expected rates of diseases related to ageing, such as cardiovascular disease, cancers and osteoporosis. Osteoporosis in particular has characteristics that are unique to HIV; there are higher rates of both osteoporosis and fractures in people with HIV, with a central role for antiretroviral therapy in its development. In particular, people with HIV who start antiretroviral therapy lose bone during the first year of therapy, leaving them potentially more prone to osteoporosis as they age. It is important to have a clear understanding of how these co-morbidities develop and how to limit their effect on overall lifespan of people living with HIV. This application brings together an international group of experienced collaborators to determine if bone loss accompanying initiation of antiretroviral therapy can be limited with a short course of a drug commonly used to treat osteoporosis; alendronate. We will conduct a clinical trial to randomize 80 people with HIV who are about to start antiretroviral therapy to either receive a short course of alendronate or a placebo taken weekly for 14 weeks and will determine the loss of bone density over the first year of antiretroviral therapy between the two treatment groups. This trial will answer an important question that will help the long-term management of not only people with HIV in Ireland, but across the world and increase our understanding of bone diseases in general, especially in those with HIV, which will help greatly in the management of this common condition.

Award Date
20 June 2014
Award Value
€795,667
Principal Investigator
Dr Patrick Mallon
Host Institution
University College Dublin
Scheme
Health Research Awards - Definitive Interventions