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

Sponsor

Hopital Lariboisière (Other)

Overall Status

Completed

CT.gov ID

NCT01813292

Collaborator

(none)

103

Enrollment

Location

Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Seropositivity

Detailed Description

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).

Study Design

Study Type:

Observational

Actual Enrollment :

103 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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 Antiretroviral Therapy.

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

HIV+ patients
male patients
patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months.

Exclusion Criteria:

chronic use of fluoroquinolones, antifungal agents, steroids
malignancy (current or previous) requiring chemotherapy or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Lariboisiere	Paris		France	75475

Sponsors and Collaborators

Hopital Lariboisière

Investigators

Principal Investigator: Pierre O Sellier, M.D, Ph.D, Hopital Lariboisiere, Paris, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Célia Lloret-Linares, MD PhD, Professor, Medicine A Department,, Hopital Lariboisière

ClinicalTrials.gov Identifier:

NCT01813292

Other Study ID Numbers:

URT-Bone-001

First Posted:

Mar 18, 2013

Last Update Posted:

Nov 22, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Célia Lloret-Linares, MD PhD, Professor, Medicine A Department,, Hopital Lariboisière

male patients

treated by TRUVADA® or VIREAD® for more than 60 months

Additional relevant MeSH terms:

HIV Seropositivity

Study Results

No Results Posted as of Nov 22, 2016