Validation of the Thai Osteoporosis Foundation and Royal College of Orthopaedic Surgeons of Thailand Clinical Practice Guideline for bone mineral density measurement in postmenopausal women

AbstractObjectiveThe primary objective of this study was to determine the sensitivity, specificity, and predictive values of the Thai Osteoporosis Foundation (TOPF) and Royal College of Orthopaedic Surgeons of Thailand (RCOST) Clinical Practice Guideline for bone mineral density (BMD) measurement for the detection of postmenopausal osteoporosis. Its secondary objective was to find better indicators to detect postmenopausal osteoporosis.MethodsPostmenopausal women were enrolled in this study between June and December 2014. The clinical risk factors following TOPF and RCOST Clinical Practice Guideline for BMD measurement were collected. Bone mineral density was measured using dual energy X-ray absorptiometry.ResultsFour hundred postmenopausal women were enrolled in the study. The mean age of the studied population was 66.16 ± 6.04 years. Twenty-seven percent of the participants had either osteoporosis of the lumbar spine, femoral neck, or total hip, of which 13.3% had osteoporosis at the lumbar spine, 21.3% had osteoporosis at the femoral neck, and 2.5% had osteoporosis of the total hip. The sensitivity and specificity for detecting osteoporosis of the whole TOPF and RCOST guideline were 96.2% and 16.7%, 98.8% and 18.7%, 90.0% and 15.1%, and 97.2% and 19.5% at the lumbar spine, femoral neck, total hip, and any sites, respectively. Multiple logistic regression analysis revealed that only OSTA ≤−1, osteopenia on X-ray and low trauma fracture after age of 40 years were significant clinical risk factors in the detection of postmenopausal osteoporosis. The Receiver Operating Characteristics (ROC) curve was used to obtain the optimum probability value of osteoporosis at any sites which revealed that the probability value of 0.2222236 would have a sensitivity of 67% and specificity of 62% as the optimal cut point to detect osteoporosis. A simple flow diagram of “OSTA ≤−1”, “Osteopenia on X-ray” and “A history of low trauma fracture after age of 40 years” was developed as a better trade-off guideline for BMD measurement.ConclusionsThis study revealed that the TOPF and RCOST guideline for BMD measurement provided a high true positive rate of disease detection but with an expense of high false positive rate. The simple flow diagram was proposed as a more appropriate guideline for BMD measurement in postmenopausal women

A landscape of micronutrient status in women through the reproductive years: Insights from seven regions in Asia

10.1177/1745506520973110Women's Health1

Thai Osteoporosis Foundation (TOPF) position statements on management of osteoporosis

The adjusted incidence rate of hip fracture in Thailand has increased more than 31% from 1997 to 2006. Mortality and morbidity after hip fracture are also high. One year mortality after a hip fracture has increased from 18% in 1999 to 21% in 2007. The Thai Osteoporosis Foundation (TOPF) developed the first Clinical Practice Guideline (CPG) in 2002 and keeps updating the CPG since then. This latest version of the CPG is our attempt to provide comprehensive positional statement on the diagnosis, prevention and treatment of osteoporosis in Thailand. The study group who revised this position statement contains experts from the TOPF, Four Royal Colleges of Thailand, includes the Orthopaedic Surgeons, Gynecologists and Obstetricians, Physiatrists, Radiologists and 2 Associations of Endocrinologists and Rheumatologists which have involved in the management of patients with osteoporosis

Prevalence and risk factors for cervical HPV infection and abnormalities in young adult women at enrolment in the multinational PATRICIA trial

Objective. We evaluated baseline data from the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681) on the association between behavioral risk factors and HPV infection and cervical abnormalities. Methods. Women completed behavioral questionnaires at baseline. Prevalence of HPV infection and cervical abnormalities (detected by cytological or histological procedures) and association with behavioral risk factors were analyzed by univariate and stepwise multivariable logistic regressions. Results. 16782 women completed questionnaires. Among 16748 women with data for HPV infection, 4059 (24.2%) were infected with any HPV type. Among 16757 women with data for cytological abnormalities, 1626 (9.7%) had a cytological abnormality, of whom 1170 (72.0%) were infected with at least one oncogenic HPV type including HPV-16 (22.7%) and HPV-18 (9.3%). Multivariable analysis (adjusted for age and region, N=14404) showed a significant association between infection with any HPV type and not living with a partner, smoking, age <15 years at first sexual intercourse, higher number of sexual partners during the past 12 months, longer duration of hormonal contraception and history of sexually transmitted infection (STI). For cervical abnormalities, only history of STI (excluding Chlamydia trachomatis) remained significant in the multivariable analysis after adjusting for HPV infection. Conclusions. Women reporting 3 + sexual partners in the past 12 months had the highest risk of HPV infection at baseline. HPV infection was the main risk factor for cervical abnormalities, and history of STIs excluding Chlamydia trachomatis increased risk to a lesser extent. Although behavioral factors can influence risk, all sexually active women are susceptible to HPV infection. (C) 2012 Elsevier Inc. All rights reserved.1273440450GlaxoSmithKline Biologicals S

Risk of first cervical HPV infection and pre-cancerous lesions after onset of sexual activity: analysis of women in the control arm of the randomized, controlled PATRICIA trial

BACKGROUND: More information is needed about time between sexual initiation and human papillomavirus (HPV) infection and development of cervical precancer. METHODS: The objectives were to investigate the time between first sexual activity and detection of first cervical HPV infection or development of first cervical intraepithelial neoplasia (CIN), and associated factors in women from the double-blind, multinational, 4-year PATRICIA trial. PATRICIA enroled women aged 15-25 years with no more than 6 lifetime sexual partners. Women were randomized 1:1 to the HPV-16/18 AS04-adjuvanted vaccine or to control, but only women from the control arm who began sexual intercourse during the study or within 6 months before enrolment, and had no HPV infection detected before the recorded date of their first sexual intercourse, were included in the present analysis. The time between onset of sexual activity and detection of the first cervical HPV infection or development of the first CIN lesion was analyzed using Kaplan-Meier and univariate and multivariable Cox proportional-hazards models. RESULTS: A total of 9337 women were enroled in the control arm of PATRICIA of whom 982 fulfilled the required inclusion criteria for analysis. A cumulative total of 28%, 44%, and 62% of the subjects had HPV infection within 12, 24, and 48 months, respectively. The overall incidence rate was 27.08 per 100 person-years. The most common oncogenic types associated with 6-month persistent infection were HPV-16 (incidence rate: 2.74 per 100 person-years), HPV-51 (2.70), HPV-52 (1.66), HPV-66 (1.14), and HPV-18 (1.09). Increased infection risk was associated with more lifetime sexual partners, being single, Chlamydia trachomatis history, and duration of hormone use. CIN1+ and CIN2+ lesions were most commonly associated with HPV-16, with an overall incidence rate of 1.87 and 1.07 per 100 person-years, respectively. Previous cervical HPV infection was most strongly associated with CIN development. CONCLUSIONS: More than 25% of women were infected with HPV within 1 year of beginning sexual activity. Without underestimating the value of vaccination at older ages, our findings emphasize its importance before sexual initiation. TRIAL REGISTRATION: clinicaltrials.gov: NCT00122681 .status: publishe

Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial

Background We evaluated the efficacy of the human papillomavirus HPV-16/18 AS04-adjuvanted vaccine against non-vaccine oncogenic HPV types in the end-of-study analysis after 4 years of follow-up in PATRICIA (PApilloma TRIal against Cancer In young Adults). Methods Healthy women aged 15-25 years with no more than six lifetime sexual partners were included in PATRICIA irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to HPV-16/18 vaccine or a control hepatitis A vaccine, via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites. The study was double-blind. The primary endpoint of PATRICIA has been reported previously; the present analysis evaluates cross-protective vaccine efficacy against non-vaccine oncogenic HPV types in the end-of-study analysis. Analyses were done for three cohorts: the according-to-protocol cohort for efficacy (ATP-E; vaccine n=8067, control n=8047), total vaccinated HPV-naive cohort (TVC-naive; no evidence of infection with 14 oncogenic HPV types at baseline, approximating young adolescents before sexual debut; vaccine n=5824, control n=5820), and the total vaccinated cohort (TVC; all women who received at least one vaccine dose, approximating catch-up populations that include sexually active women; vaccine n=9319, control=9325). Vaccine efficacy was evaluated against 6-month persistent infection, cervical intraepithelial neoplasia grade 2 or greater (CIN2+) associated with 12 non-vaccine HPV types (individually or as composite endpoints), and CIN3+ associated with the composite of 12 non-vaccine HPV types. This study is registered with ClinicalTrials.gov, number NCT00122681. Findings Consistent vaccine efficacy against persistent infection and CIN2+ (with or without HPV-16/18 co-infection) was seen across cohorts for HPV-33, HPV-31, HPV-45, and HPV-51. In the most conservative analysis of vaccine efficacy against CIN2+, where all cases co-infected with HPV-16/18 were removed, vaccine efficacy was noted for HPV-33 in all cohorts, and for HPV-31 in the ATP-E and TVC-naive. Vaccine efficacy against CIN2+ associated with the composite of 12 non-vaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), with or without HPV-16/18 co-infection, was 46.8% (95% CI 30.7-59.4) in the ATP-E, 56.2% (37.2-69.9) in the TVC-naive, and 34.2% (20.4-45.8) in the TVC. Corresponding values for CIN3+ were 73.8% (48.3-87.9), 91.4% (65.0-99.0), and 47.5% (22.8-64.8). Interpretation Data from the end-of-study analysis of PATRICIA show cross-protective efficacy of the HPV-16/18 vaccine against four oncogenic non-vaccine HPV types-HPV-33, HPV-31, HPV-45, and HPV-51-in different trial cohorts representing diverse groups of women.131100110GlaxoSmithKline Biologicals [NCT00122681/580299/008]Merck Sharp & Dohme (Sanofi Pasteur MSD)Helsinki University Hospital Research InstituteCSLGlaxoSmithKlineMerck Co.VaestoliittoGlaxoSmithKline Biologicals [NCT00122681/580299/008

Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial

We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+