Clinical Trial: Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Comparative Study of Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV + Men Being Given Tenofovir With FTC, Emtricitabine (TRUVADA®), or Without (VIREAD®), as Part of Their A

Brief Summary:

HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality.

The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.

Detailed Summary: Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be studied using a HR-pQCT scan (Xtreme, Scanco).
Sponsor: Hopital Lariboisière

Current Primary Outcome: Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA) [ Time Frame: ongoing, during the study period, according to the availability of DXA ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hopital Lariboisière

Dates:
Date Received: March 12, 2013
Date Started: May 2013
Date Completion:
Last Updated: November 21, 2016
Last Verified: November 2016