Ontology highlight
ABSTRACT: Objective
Bone loss in people with HIV (PWH) is poorly understood. Switching tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) has yielded bone mineral density (BMD) increases. PETRAM (NCT#:03405012) investigated whether BMD and bone turnover changes correlate.Design
Open-label, randomized controlled trial.Setting
Single-site, outpatient, secondary care.Participants
Nonosteoporotic, virologically suppressed, cis-male PWH taking TDF/emtricitabine (FTC)/rilpivirine (RPV) for more than 24 weeks.Intervention
Continuing TDF/FTC/RPV versus switching to TAF/FTC/RPV (1 : 1 randomization).Main outcome measures
:[ 18 F]NaF-PET/CT for bone turnover (standardized uptake values, SUV mean ) and dual-energy x-ray absorptiometry for lumbar spine and total hip BMD.Results
Thirty-two men, median age 51 years, 76% white, median duration TDF/FTC/RPV 49 months, were randomized between 31 August 2018 and 09 March 2020. Sixteen TAF:11 TDF were analyzed. Baseline-final scan range was 23-103 (median 55) weeks. LS-SUV mean decreased for both groups (TAF -7.9% [95% confidence interval -14.4, -1.5], TDF -5.3% [-12.1,1.5], P = 0.57). TH-SUV mean showed minimal changes (TAF +0.3% [-12.2,12.8], TDF +2.9% [-11.1,16.9], P = 0.77). LS-BMD changes were slightly more favorable with TAF but failed to reach significance (TAF +1.7% [0.3,3.1], TDF -0.3 [-1.8,1.2], P = 0.06). Bone turnover markers decreased more with TAF ([CTX -35.3% [-45.7, -24.9], P1NP -17.6% [-26.2, -8.5]) than TDF (-11.6% [-28.8, +5.6] and -6.9% [-19.2, +5.4] respectively); statistical significance was only observed for CTX ( P = 0.02, P1NP, P = 0.17).Conclusion
Contrary to our hypothesis, lumbar spine and total hip regional bone formation (SUV mean ) and BMD did not differ postswitch to TAF. However, improved LS-BMD and CTX echo other TAF-switch studies. The lack of difference in SUV mean may be due to inadequate power.
SUBMITTER: Moore AEB
PROVIDER: S-EPMC10906193 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
Moore Amelia E B AEB Burns James E JE Sally Deirdre D Milinkovic Ana A Krokos Georgios G John Joemon J Rookyard Christopher C Borca Alessandro A Pool Erica R M ERM Tostevin Anna A Harman Alyss A Dulnoan Dwight S DS Gilson Richard R Arenas-Pinto Alejandro A Cook Gary J R GJR Saunders John J Saunders John J Dunn David D Blake Glen M GM Pett Sarah L SL
AIDS (London, England) 20240201 4
<h4>Objective</h4>Bone loss in people with HIV (PWH) is poorly understood. Switching tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) has yielded bone mineral density (BMD) increases. PETRAM (NCT#:03405012) investigated whether BMD and bone turnover changes correlate.<h4>Design</h4>Open-label, randomized controlled trial.<h4>Setting</h4>Single-site, outpatient, secondary care.<h4>Participants</h4>Nonosteoporotic, virologically suppressed, cis-male PWH taking TDF/emtricitabine ( ...[more]