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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hopital Lariboisière
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT01813292
First received: March 12, 2013
Last updated: December 5, 2013
Last verified: December 2013

March 12, 2013
December 5, 2013
November 2012
January 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01813292 on ClinicalTrials.gov Archive Site
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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
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Non-Probability Sample

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

HIV+
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2014
January 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
Male
18 Years to 55 Years
No
France
 
NCT01813292
URT-Bone-001
No
Stephane Mouly, MD PhD, Hopital Lariboisière
Hopital Lariboisière
Not Provided
Principal Investigator: Pierre O Sellier, M.D, Ph.D Hopital Lariboisiere, Paris, France
Hopital Lariboisière
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP