We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01813292
First Posted: March 18, 2013
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière
March 12, 2013
March 18, 2013
November 22, 2016
May 2013
May 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01813292 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine
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.

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.

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).
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months.
HIV Seropositivity
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
July 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01813292
URT-Bone-001
No
Not Provided
Plan to Share IPD: No
Célia Lloret-Linares, MD PhD, Hopital Lariboisière
Hopital Lariboisière
Not Provided
Principal Investigator: Pierre O Sellier, M.D, Ph.D Hopital Lariboisiere, Paris, France
Hopital Lariboisière
November 2016