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.
1 other identifier
observational
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedNovember 22, 2016
November 1, 2016
1 year
March 12, 2013
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months.
You may qualify if:
- HIV+ patients
- male patients
- patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months.
You may not qualify if:
- chronic use of fluoroquinolones, antifungal agents, steroids
- malignancy (current or previous) requiring chemotherapy or radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Lariboisiere
Paris, 75475, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre O Sellier, M.D, Ph.D
Hopital Lariboisiere, Paris, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Medicine A Department,
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 18, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
July 1, 2014
Last Updated
November 22, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share