Initiation of ART is associated with early reductions in BMD. This sub-study helped determine the role of tenofovir in any early loss of BMD and identify if all patients experienced early loss of BMD or if greater losses were experienced by those randomised to NRTI/tenofovir containing ART.
The objective of this sub-study was to compare changes in bone mineral density between the two treatment strategies, to compare markers of bone metabolism between the two groups and to determine the relationship between changes in bone mineral density and changes in body composition.
The sample size was 71 patients per treatment arm (142 in total) from selected participating sites.