Bone Mineral Density in HIV-Negative Men Participating in a Tenofovir Pre-Exposure Prophylaxis Randomized Clinical Trial in San Francisco
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{"title"=>"Bone mineral density in HIV-negative men participating in a tenofovir pre-exposure prophylaxis randomized clinical trial in San Francisco", "type"=>"journal", "authors"=>[{"first_name"=>"Albert Y.", "last_name"=>"Liu", "scopus_author_id"=>"37031463000"}, {"first_name"=>"Eric", "last_name"=>"Vittinghoff", "scopus_author_id"=>"7005264413"}, {"first_name"=>"Deborah E.", "last_name"=>"Sellmeyer", "scopus_author_id"=>"6602804910"}, {"first_name"=>"Risha", "last_name"=>"Irvin", "scopus_author_id"=>"50761142600"}, {"first_name"=>"Kathleen", "last_name"=>"Mulligan", "scopus_author_id"=>"7005703105"}, {"first_name"=>"Kenneth", "last_name"=>"Mayer", "scopus_author_id"=>"7201681809"}, {"first_name"=>"Melanie", "last_name"=>"Thompson", "scopus_author_id"=>"35450433400"}, {"first_name"=>"Robert", "last_name"=>"Grant", "scopus_author_id"=>"7402006018"}, {"first_name"=>"Sonal", "last_name"=>"Pathak", "scopus_author_id"=>"35760317600"}, {"first_name"=>"Brandon", "last_name"=>"O'Hara", "scopus_author_id"=>"55315783500"}, {"first_name"=>"Roman", "last_name"=>"Gvetadze", "scopus_author_id"=>"12773884300"}, {"first_name"=>"Kata", "last_name"=>"Chillag", "scopus_author_id"=>"55937321400"}, {"first_name"=>"Lisa", "last_name"=>"Grohskopf", "scopus_author_id"=>"57027845300"}, {"first_name"=>"Susan P.", "last_name"=>"Buchbinder", "scopus_author_id"=>"35391587900"}], "year"=>2011, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-80052279128", "sgr"=>"80052279128", "issn"=>"19326203", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"21897852", "doi"=>"10.1371/journal.pone.0023688", "pui"=>"362461747"}, "id"=>"0ac8a987-cb64-34a1-a7e2-ddf46c3975d6", "abstract"=>"BACKGROUND Pre-exposure prophylaxis (PrEP) trials are evaluating regimens containing tenofovir-disoproxil fumarate (TDF) for HIV prevention. We determined the baseline prevalence of low bone mineral density (BMD) and the effect of TDF on BMD in men who have sex with men (MSM) in a PrEP trial in San Francisco. METHODS/FINDINGS We evaluated 1) the prevalence of low BMD using Dual Energy X-ray Absorptiometry (DEXA) in a baseline cohort of 210 HIV-uninfected MSM who screened for a randomized clinical trial of daily TDF vs. placebo, and 2) the effects of TDF on BMD in a longitudinal cohort of 184 enrolled men. Half began study drug after a 9-month delay to evaluate changes in risk behavior associated with pill-use. At baseline, 20 participants (10%) had low BMD (Z score≤-2.0 at the L2-L4 spine, total hip, or femoral neck). Low BMD was associated with amphetamine (OR = 5.86, 95% CI 1.70-20.20) and inhalant (OR = 4.57, 95% CI 1.32-15.81) use; men taking multivitamins, calcium, or vitamin D were less likely to have low BMD at baseline (OR = 0.26, 95% CI 0.10-0.71). In the longitudinal analysis, there was a 1.1% net decrease in mean BMD in the TDF vs. the pre-treatment/placebo group at the femoral neck (95% CI 0.4-1.9%), 0.8% net decline at the total hip (95% CI 0.3-1.3%), and 0.7% at the L2-L4 spine (95% CI -0.1-1.5%). At 24 months, 13% vs. 6% of participants experienced >5% BMD loss at the femoral neck in the TDF vs. placebo groups (p = 0.13). CONCLUSIONS Ten percent of HIV-negative MSM had low BMD at baseline. TDF use resulted in a small but statistically significant decline in BMD at the total hip and femoral neck. Larger studies with longer follow-up are needed to determine the trajectory of BMD changes and any association with clinical fractures. TRIAL REGISTRATION ClinicalTrials.gov: NCT00131677.", "link"=>"http://www.mendeley.com/research/bone-mineral-density-hivnegative-men-participating-tenofovir-preexposure-prophylaxis-randomized-clin", "reader_count"=>68, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Librarian"=>2, "Researcher"=>6, "Student > Doctoral Student"=>6, "Student > Ph. D. Student"=>8, "Student > Postgraduate"=>5, "Student > Master"=>22, "Other"=>7, "Student > Bachelor"=>5, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Librarian"=>2, "Researcher"=>6, "Student > Doctoral Student"=>6, "Student > Ph. D. Student"=>8, "Student > Postgraduate"=>5, "Student > Master"=>22, "Other"=>7, "Student > Bachelor"=>5, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>5, "Mathematics"=>1, "Medicine and Dentistry"=>38, "Agricultural and Biological Sciences"=>5, "Philosophy"=>1, "Sports and Recreations"=>1, "Psychology"=>2, "Chemistry"=>1, "Social Sciences"=>8}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>38}, "Chemistry"=>{"Chemistry"=>1}, "Social Sciences"=>{"Social Sciences"=>8}, "Sports and Recreations"=>{"Sports and Recreations"=>1}, "Psychology"=>{"Psychology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>5}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>5}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"United States"=>1, "Brazil"=>1, "United Kingdom"=>1, "Ethiopia"=>1, "Spain"=>1}, "group_count"=>7}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/741499"], "description"=>"<p>Trajectory of mean percent change in BMD at the femoral neck (a), total hip (b), and L2–L4 spine (c), by treatment arm. Solid lines represent the immediate arm, and dashed lines represent the delayed arm. Participants who discontinued study drug due to >5% BMD loss from baseline are included. BMD, bone mineral density.</p>", "links"=>[], "tags"=>["percent", "bmd", "baseline", "femoral"], "article_id"=>411857, "categories"=>["Ecology", "Virology", "Infectious Diseases", "Biotechnology", "Pharmacology", "Physiology"], "users"=>["Albert Y. Liu", "Eric Vittinghoff", "Deborah E. Sellmeyer", "Risha Irvin", "Kathleen Mulligan", "Kenneth Mayer", "Melanie Thompson", "Robert Grant", "Sonal Pathak", "Brandon O'Hara", "Roman Gvetadze", "Kata Chillag", "Lisa Grohskopf", "Susan P. Buchbinder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023688.g003", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Mean_percent_change_in_BMD_from_baseline_at_the_total_spine_total_hip_and_femoral_neck_/411857", "title"=>"Mean percent change in BMD from baseline at the total spine, total hip, and femoral neck.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-29 00:30:57"}
  • {"files"=>["https://ndownloader.figshare.com/files/741621"], "description"=>"<p>Distribution curves of percent BMD change from baseline at last scan at the femoral neck (a), total hip (b), L2–L4 spine (c). BMD, bone mineral density;TDF, tenofovir disoproxil fumarate.</p>", "links"=>[], "tags"=>["curves", "demonstrating", "percent", "changes", "24", "months", "placebo", "tdf", "anatomic"], "article_id"=>411970, "categories"=>["Ecology", "Virology", "Infectious Diseases", "Biotechnology", "Pharmacology", "Physiology"], "users"=>["Albert Y. Liu", "Eric Vittinghoff", "Deborah E. Sellmeyer", "Risha Irvin", "Kathleen Mulligan", "Kenneth Mayer", "Melanie Thompson", "Robert Grant", "Sonal Pathak", "Brandon O'Hara", "Roman Gvetadze", "Kata Chillag", "Lisa Grohskopf", "Susan P. Buchbinder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023688.g004", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Normal_curves_demonstrating_percent_changes_in_bone_density_at_24_months_in_the_placebo_vs_TDF_groups_by_anatomic_site_/411970", "title"=>"Normal curves demonstrating percent changes in bone density at 24 months in the placebo vs. TDF groups, by anatomic site.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-29 00:32:50"}
  • {"files"=>["https://ndownloader.figshare.com/files/741747"], "description"=>"†<p>Baseline only = participants with only 1 DEXA performed; includes 14 screen failures.</p><p>‡TDF/placebo = participants randomized to TDF or placebo who had at least 1 follow-up DEXA and were included in the longitudinal cohort.</p><p>*<i>P</i> value compares TDF vs. placebo arms of longitudinal cohort.</p><p>¥For baseline only group, alcohol and recreational drug use data available for 12/26 participants who enrolled in the study.</p><p>\n <b>DEXA, dual energy X-ray absorptiometry; TDF, tenofovir disoproxil fumarate; BMD, bone mineral density.</b></p>", "links"=>[], "tags"=>["characteristics", "baseline", "longitudinal"], "article_id"=>412106, "categories"=>["Ecology", "Virology", "Infectious Diseases", "Biotechnology", "Pharmacology", "Physiology"], "users"=>["Albert Y. Liu", "Eric Vittinghoff", "Deborah E. Sellmeyer", "Risha Irvin", "Kathleen Mulligan", "Kenneth Mayer", "Melanie Thompson", "Robert Grant", "Sonal Pathak", "Brandon O'Hara", "Roman Gvetadze", "Kata Chillag", "Lisa Grohskopf", "Susan P. Buchbinder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023688.t001", "stats"=>{"downloads"=>3, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_of_participants_in_the_baseline_only_and_longitudinal_analysis_cohorts_/412106", "title"=>"Baseline characteristics of participants in the baseline only and longitudinal analysis cohorts.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-29 00:35:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/373976", "https://ndownloader.figshare.com/files/374028"], "description"=>"<div><h3>Background</h3><p>Pre-exposure prophylaxis (PrEP) trials are evaluating regimens containing tenofovir-disoproxil fumarate (TDF) for HIV prevention. We determined the baseline prevalence of low bone mineral density (BMD) and the effect of TDF on BMD in men who have sex with men (MSM) in a PrEP trial in San Francisco.</p> <h3>Methods/Findings</h3><p>We evaluated 1) the prevalence of low BMD using Dual Energy X-ray Absorptiometry (DEXA) in a baseline cohort of 210 HIV-uninfected MSM who screened for a randomized clinical trial of daily TDF vs. placebo, and 2) the effects of TDF on BMD in a longitudinal cohort of 184 enrolled men. Half began study drug after a 9-month delay to evaluate changes in risk behavior associated with pill-use. At baseline, 20 participants (10%) had low BMD (Z score≤−2.0 at the L2–L4 spine, total hip, or femoral neck). Low BMD was associated with amphetamine (OR = 5.86, 95% CI 1.70–20.20) and inhalant (OR = 4.57, 95% CI 1.32–15.81) use; men taking multivitamins, calcium, or vitamin D were less likely to have low BMD at baseline (OR = 0.26, 95% CI 0.10–0.71). In the longitudinal analysis, there was a 1.1% net decrease in mean BMD in the TDF vs. the pre-treatment/placebo group at the femoral neck (95% CI 0.4–1.9%), 0.8% net decline at the total hip (95% CI 0.3–1.3%), and 0.7% at the L2–L4 spine (95% CI −0.1–1.5%). At 24 months, 13% vs. 6% of participants experienced >5% BMD loss at the femoral neck in the TDF vs. placebo groups (p = 0.13).</p> <h3>Conclusions</h3><p>Ten percent of HIV-negative MSM had low BMD at baseline. TDF use resulted in a small but statistically significant decline in BMD at the total hip and femoral neck. Larger studies with longer follow-up are needed to determine the trajectory of BMD changes and any association with clinical fractures.</p> <h3>Trial Registration</h3><p>ClinicalTrials.gov: <a href=\"http://clinicaltrials.gov/ct2/show/NCT00131677\">NCT00131677</a></p> </div>", "links"=>[], "tags"=>["hiv-negative", "men", "participating", "tenofovir", "pre-exposure", "prophylaxis", "randomized", "san", "francisco"], "article_id"=>133846, "categories"=>["Cancer", "Biotechnology", "Pharmacology", "Physiology", "Ecology"], "users"=>["Albert Y. Liu", "Eric Vittinghoff", "Deborah E. Sellmeyer", "Risha Irvin", "Kathleen Mulligan", "Kenneth Mayer", "Melanie Thompson", "Robert Grant", "Sonal Pathak", "Brandon O'Hara", "Roman Gvetadze", "Kata Chillag", "Lisa Grohskopf", "Susan P. Buchbinder"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023688.s001", "https://dx.doi.org/10.1371/journal.pone.0023688.s002"], "stats"=>{"downloads"=>26, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Bone_Mineral_Density_in_HIV_Negative_Men_Participating_in_a_Tenofovir_Pre_Exposure_Prophylaxis_Randomized_Clinical_Trial_in_San_Francisco/133846", "title"=>"Bone Mineral Density in HIV-Negative Men Participating in a Tenofovir Pre-Exposure Prophylaxis Randomized Clinical Trial in San Francisco", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-08-29 01:04:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/741409"], "description"=>"<p>Participants were randomly assigned to one of four arms. Participants in the 2 immediate arms (TDF vs. placebo) initiated study drug at enrollment; those in the 2 delayed arms (TDF vs. placebo) initiated study drug at the 9 month visit. TDF, tenofovir disoproxil fumarate.</p>", "links"=>[], "tags"=>["Virology", "Infectious diseases", "public health and epidemiology", "physiology", "pharmacology", "rheumatology"], "article_id"=>411763, "categories"=>["Ecology", "Virology", "Infectious Diseases", "Biotechnology", "Pharmacology", "Physiology"], "users"=>["Albert Y. Liu", "Eric Vittinghoff", "Deborah E. Sellmeyer", "Risha Irvin", "Kathleen Mulligan", "Kenneth Mayer", "Melanie Thompson", "Robert Grant", "Sonal Pathak", "Brandon O'Hara", "Roman Gvetadze", "Kata Chillag", "Lisa Grohskopf", "Susan P. Buchbinder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023688.g002", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_design_/411763", "title"=>"Study design.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-29 00:29:23"}
  • {"files"=>["https://ndownloader.figshare.com/files/741705"], "description"=>"<p>†BMI, alcohol, and recreational drug use data were available in 196 subjects who enrolled.</p><p>‡There were no cases of low BMD among Asian/Pacific Islander men, heavy alcohol users, and those who reported use of corticosteroids, anabolic hormones, or muscle building supplements.</p><p>*Tobacco use and exercise/family history data available in 155 participants who enrolled.</p>", "links"=>[], "tags"=>["parameters"], "article_id"=>412065, "categories"=>["Ecology", "Virology", "Infectious Diseases", "Biotechnology", "Pharmacology", "Physiology"], "users"=>["Albert Y. Liu", "Eric Vittinghoff", "Deborah E. Sellmeyer", "Risha Irvin", "Kathleen Mulligan", "Kenneth Mayer", "Melanie Thompson", "Robert Grant", "Sonal Pathak", "Brandon O'Hara", "Roman Gvetadze", "Kata Chillag", "Lisa Grohskopf", "Susan P. Buchbinder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023688.t002", "stats"=>{"downloads"=>4, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Selected_Parameters_Associated_with_Low_Bone_Mineral_Density_Z_score_8804_8722_2_0_/412065", "title"=>"Selected Parameters Associated with Low Bone Mineral Density (Z score≤−2.0).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-29 00:34:25"}
  • {"files"=>["https://ndownloader.figshare.com/files/741263"], "description"=>"<p>The <b><i>baseline only cohort</i></b> shown in red shading includes 26 men who had only 1 DEXA scan performed, either during screening or after enrollment. The <b><i>longitudinal</i></b> cohort shown in green shading includes 184 men who had a baseline and at least 1 additional scan during study follow-up. Of the 210 participants who had a baseline DEXA scan, 178 had this scan performed during screening, and 32 shortly after enrollment (prior to the protocol amendment moving DEXA scans to screening). †Delayed arm participants who enrolled prior to protocol amendment had baseline DEXA performed at 9 months prior to starting study drug. DEXA, dual energy X-ray absorptiometry; TDF, tenofovir disoproxil fumarate.</p>", "links"=>[], "tags"=>["Virology", "Infectious diseases", "public health and epidemiology", "physiology", "pharmacology", "rheumatology"], "article_id"=>411615, "categories"=>["Ecology", "Virology", "Infectious Diseases", "Biotechnology", "Pharmacology", "Physiology"], "users"=>["Albert Y. Liu", "Eric Vittinghoff", "Deborah E. Sellmeyer", "Risha Irvin", "Kathleen Mulligan", "Kenneth Mayer", "Melanie Thompson", "Robert Grant", "Sonal Pathak", "Brandon O'Hara", "Roman Gvetadze", "Kata Chillag", "Lisa Grohskopf", "Susan P. Buchbinder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023688.g001", "stats"=>{"downloads"=>1, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_design_and_participant_disposition_/411615", "title"=>"Study design and participant disposition.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-29 00:26:55"}

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