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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01813292
Other study ID # URT-Bone-001
Secondary ID
Status Completed
Phase N/A
First received March 12, 2013
Last updated November 21, 2016
Start date May 2013
Est. completion date July 2014

Study information

Verified date November 2016
Source Hopital Lariboisière
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date July 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
France Hopital Lariboisiere Paris

Sponsors (1)

Lead Sponsor Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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