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  • br Materials and methods br Participants br

    2022-07-28


    2. Materials and methods
    2.1. Participants
    This was a cross-sectional study that included 70 men treated with ADT for PCa, 52 men treated with non-hormonal therapies (including active surveillance) for PCa (PCa controls) and 70 men not diagnosed with PCa (healthy controls). Men treated with ADT in this analysis were involved in a larger randomised controlled trial involving exercise training and nutritional supplementation [29]. This cross sectional study includes the baseline data from these ADT-treated men. Eligible participants were men aged 50–85 years. Participants were excluded if they did not have the ability to complete surveys in the English lan-guage, had any disorder(s) known to affect bone, calcium or vitamin D N,N-Dimethylsphingosine (other than hypogonadism), were currently receiving pharmacological intervention known to affect bone metabolism (other than ADT), had supplemented with protein, calcium (> 600 mg/day) or vitamin D (> 1000 IU/day) in the past three months, had undertaken progressive resistance training (> 1 session/week) or regular weight bearing impact exercise (> 150 min/week) in the past three months, were current smokers, had a weight > 159 kg or had any absolute contraindications to exercise testing according to the American College of Sports Medicine guidelines [30]. Specific to ADT-treated men, treatment must have been pharmacological (surgical orchiectomy ex-cluded) and administered for > 12 weeks at enrolment.
    ADT-treated men were recruited between April 2014 and November 2017 via clinician referral from Alfred Health (Melbourne, Australia), Peter MacCallum Cancer Centre (Victoria, Australia) and six private urology practices (Victoria, Australia), as well as from 32 PCa support groups (Victoria, Australia) and advertisements in state/local news-papers. PCa and healthy controls were recruited between October 2014 
    and February 2016 from PCa support groups and advertisements in state/local newspapers. The study was conducted in accordance with Declaration of Helsinki and was approved by the human research ethics committees at Deakin University (HREC 2013-184), Alfred Health (Project No: 455/15) and Peter MacCallum Cancer Centre (Project No: 17/118). All participants gave their informed written consent prior to participation.
    2.2. Measurements
    Lumbar spine (L1-L4) and proximal femur (femoral neck and total hip) aBMD (g/cm2) were assessed using DXA (Lunar iDXA, GE Lunar Corp., Madison, WI, USA) and analysed using enCORE software (ver-sion 12.30.008), by a researcher blinded to group allocation. All scans were reviewed for artefacts or local structural abnormalities known to influence BMD and where necessary, artefacts were marked and ex-cluded from analysis. For the lumbar spine, T-scores from adjacent vertebrae were reviewed to determine any large differences in BMD from one vertebrae to the next. Individual vertebrae affected by structural abnormalities causing artificial elevation of BMD (T-score ≥ 2 SDs different to adjacent vertebrae) were excluded from the analysis such that the overall lumbar spine BMD results included only the remaining vertebrae (N = 11 participants with verterbrae ex-cluded). Additionally, two participants (PCa control, N = 1; healthy control, N = 1) with hip arthroplasty were excluded from the analysis of proximal femur sites. One ADT-treated participant was excluded from analysis of total hip aBMD due an abnormally high value (T-score of 7.3). The short-term coefficient of variation (CV) for aBMD measures range from 0.6% to 1.0% within our laboratory. The lowest T-score of the lumbar spine, femoral neck and/or total hip was used to classify participants with osteoporosis (T-score ≤ −2.5) or osteopenia (T-score between −2.5 and −1), consistent with World Health Organization criteria [31].