scholarly journals The influence of antiresorptive bone medication on the effect of high-intensity resistance and impact training on osteoporotic fracture risk in postmenopausal women with low bone mass: protocol for the MEDEX-OP randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029895
Author(s):  
Melanie Fischbacher ◽  
Benjamin K Weeks ◽  
Belinda R Beck
Keyword(s):  
Bone Mineral Density ◽  
Randomised Controlled Trial ◽  
Bone Mass ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
High Intensity ◽  
Controlled Trial ◽  
Low Bone Mass ◽  
Mineral Density ◽  
Randomised Controlled

IntroductionAntiresorptive medications increase bone density and decrease vertebral fracture, while high-intensity resistance and impact training (HiRIT) increases balance, bone and muscle strength decreasing risk for falls and fractures. Medications are typically prescribed by doctors and exercise by exercise specialists, frequently in isolation.ObjectiveOur primary aim is to determine the effect of an 8-month HiRIT programme with or without osteoporosis medications on bone mineral density (BMD) of the spine and hip in postmenopausal women with low bone mass.Methods and analysisOne hundred and sixty postmenopausal women with low bone mass will be recruited from the community to participate in an 8-month randomised controlled trial. Participants will be on stable doses of antiresorptive bone medication for at least 12 months (n=80) or have not taken bone medications for at least 12 months (n=80). Participants will be block randomised, stratified by medication intake, to twice-weekly 40-min supervised sessions of HiRIT or a low-intensity exercise programme (control). Primary outcomes include change in lumbar spine and total hip areal bone mineral density. Secondary outcomes include whole body, femoral neck and forearm BMD, proximal femur bone geometry and volumetric density, vertebral morphology, body composition, anthropometry, physical function, posture, rate of falls, osteoarthritis symptoms, pelvic floor health, quality of life, physical activity enjoyment, resting blood pressure, safety and compliance. All outcomes will be assessed at baseline and 8 months and intention-to-treat and per-protocol analyses will be conducted. Repeated measure analysis of covariance will be used to determine intervention effects on outcome measures, controlling for initial values, compliance and other variables found to differ between groups at baseline.Ethics and disseminationThe study has been approved by Griffith University Human Research Ethics Committee (Ref: 2017/739). Results will be reported in peer-reviewed journals and at conferences.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001511325).

scholarly journals Effects of Arzoxifene on Bone Mineral Density and Endometrium in Postmenopausal Women with Normal or Low Bone Mass

2009 ◽  
Vol 94 (7) ◽  
pp. 2284-2289 ◽  
Author(s):  
M. Bolognese ◽  
J. H. Krege ◽  
W. H. Utian ◽  
R. Feldman ◽  
S. Broy ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Placebo Group ◽  
Bone Mass ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Endometrial Thickness ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Low Bone Mass ◽  
Mineral Density

Introduction: Arzoxifene, a benzothiophene estrogen agonist/antagonist, is being developed for prevention and treatment of osteoporosis and for risk reduction of invasive breast cancer in postmenopausal women. Methods: The effects of arzoxifene 20 mg/d on bone mineral density (BMD), uterine safety, and overall safety were studied in the FOUNDATION study, a 2-yr randomized, placebo-controlled trial including 331 postmenopausal women with normal to low bone mass. Results: Compared to placebo, arzoxifene significantly increased lumbar spine (+2.9%) and total hip (+2.2%) BMD. Arzoxifene decreased biochemical markers of bone metabolism compared to placebo. Changes in breast density were neutral or slightly decreased in the arzoxifene vs. placebo group. There was no evidence of endometrial hyperplasia or carcinoma in the arzoxifene group as assessed by central review of baseline and follow-up endometrial biopsies. There was no significant change between the groups in endometrial thickness assessed by transvaginal ultrasound. The incidence of uterine polyps and vaginal bleeding was not significantly different between the groups. Vulvovaginal mycotic infection was the only adverse event significantly increased in the arzoxifene vs. placebo group. Hot flushes were not significantly different between the groups. Conclusion: In postmenopausal women with normal to low bone mass, arzoxifene 20 mg/d increased BMD at the spine and hip and had a neutral effect on the uterus and endometrium.

scholarly journals O13 Pregnancy vitamin D supplementation leads to greater offspring bone mineral density at 4 years: the MAVIDOS randomised placebo controlled trial

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Elizabeth M Curtis ◽  
Rebecca J Moon ◽  
Stefania D'Angelo ◽  
Sarah R Crozier ◽  
Nicholas J Bishop ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Vitamin D ◽  
Bone Mass ◽  
Bone Mineral ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Whole Body ◽  
Mineral Density ◽  
Double Blind ◽  
Randomised Controlled

Abstract Background Observational studies have demonstrated associations between maternal gestational vitamin D status and offspring bone health. We have recently shown, in a randomised controlled trial, that pregnancy vitamin D supplementation leads to improved offspring bone mass at birth amongst winter deliveries (when background 25(OH)-vitamin D levels are lowest). In the present analysis, we aimed to evaluate whether the beneficial effect of pregnancy vitamin D supplementation on neonatal bone mass is sustained into early childhood, with bone indices assessed at age 4 years in a subset of participants of the MAVIDOS trial. Methods Pregnant women were randomised in Southampton, Oxford and Sheffield, in a double-blind design, to 1000 IU/day cholecalciferol or matched placebo from 14 weeks’ gestation to birth. At 4 years of age (Southampton participants only, n = 723 births), offspring assessments included anthropometry, whole-body dual-energy x-ray absorptiometry (DXA) [Hologic Horizon, yielding whole body less head (WBLH) bone mineral content (BMC), bone mineral density (BMD), bone area (BA) and lean mass (LM)], and a maternal questionnaire. Linear regression was used to estimate the mean difference (represented by β) in outcomes between the two randomisation arms, adjusted for sex and age at DXA. Further models were additionally adjusted for gestational age, maternal BMI, and child’s sedentary time. All outcomes were standardised to a standard deviation scale, for ease of comparison. Full ethics and MHRA approvals were granted. Results 564 children attended the 4-year visit; 452 had a useable DXA with minimal movement artefact. Maternal pregnancy vitamin D supplementation led to greater offspring indices of bone mass compared with placebo, irrespective of season. For example, WBLH BMD at age 4 years was greater in the offspring of supplemented mothers [β = 0.18 SD (95%CI: 0.00, 0.35), p = 0.047]; there was also evidence of greater LM in the intervention group [β = 0.15 SD (95%CI: -0.02, 0.31), p = 0.081]. In fully adjusted models associations were consistent for lumbar spine indices and for BA and BMC. In keeping with the offspring findings, maternal vitamin D supplementation led to significantly higher maternal plasma 25(OH)D concentrations in late pregnancy (34 weeks’ gestation): placebo group (median(IQR)): 42.4 nmol/l (23.3, 56.4); vitamin D group: 67.4 nmol/l (56.2, 80.3); p < 0.001. Conclusion This is the first ever demonstration in a large placebo-controlled, double-blind randomised controlled trial that maternal pregnancy vitamin D supplementation leads to improved bone and lean mass in children. Our findings suggest that maternal cholecalciferol supplementation may have lasting benefits for offspring musculoskeletal health and thus represent an important public health message. This work was supported by grants from Versus Arthritis 17702, Medical Research Council (MRC #405050259; #U105960371), Bupa Foundation, NIHR Southampton Biomedical Research Centre (BRC), University of Southampton, and NIHR Oxford BRC, University of Oxford. EC was supported by the Wellcome Trust (#201268/Z/16/Z). Disclosures E.M. Curtis None. R.J. Moon None. S. D'Angelo None. S.R. Crozier None. N.J. Bishop None. S. Gopal- Kothandapani None. S. Kennedy None. A.T. Papageorghiou None. R. Fraser None. S.V. Gandhi None. I. Schoenmakers None. A. Prentice None. H.M. Inskip None. K.M. Godfrey None. K. Javaid None. R. Eastell None. C. Cooper None. N.C. Harvey None.

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