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Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial.
Havens, PL, Stephensen, CB, Van Loan, MD, Schuster, GU, Woodhouse, LR, Flynn, PM, Gordon, CM, Pan, CG, Rutledge, B, Harris, DR, et al
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2018;(2):220-228
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Abstract
BACKGROUND Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that vitamin D3 (VITD3) would increase BMD in youth receiving TDF. METHODS This was a randomized, double-blind, placebo-controlled trial of directly observed VITD3 vs placebo every 4 weeks for 48 weeks in youth aged 16-24 years with HIV, RNA load <200 copies/mL, taking TDF-containing combination antiretroviral therapy (TDF-cART) for ≥180 days. Participants (N = 214) received a daily multivitamin containing VITD3 400 IU and calcium 162 mg, plus monthly randomized VITD3 50000 IU (n = 109) or placebo (n = 105). Outcome was change from baseline to week 48 in lumbar spine BMD (LSBMD). Data presented are median (Q1, Q3). RESULTS Participants were aged 22.0 (21.0, 23.0) years, 84% were male, and 74% were black/African American. At baseline, 62% had 25-hydroxy vitamin D (25-OHD) <20 ng/mL. Multivitamin adherence was 49% (29%, 69%), and VITD3/placebo adherence 100% (100%, 100%). Vitamin D intake was 2020 (1914, 2168) and 284 (179, 394) IU/day, and serum 25-OHD concentration was 36.9 (30.5, 42.4) and 20.6 (14.4, 25.8) ng/mL at 48 weeks in VITD3 and placebo groups, respectively (P < .001). From baseline to week 48, LSBMD increased by 1.15% (-0.75% to 2.74%) in the VITD3 group (n = 99; P < .001) and 0.09% (-1.49% to 2.61%) in the placebo group (n = 89; P = .25), without between-group difference (P = .12). VITD3 group changes occurred with baseline 25-OHD <20 ng/mL (1.17% [-.82% to 2.90%]; P = .004) and ≥20 ng/mL (0.93% [-.26% to 2.15%]; P = .033). CONCLUSIONS For youth taking TDF-cART, LSBMD increased through 48 weeks with VITD3 plus multivitamin, but not with placebo plus multivitamin, independent of baseline vitamin D status. CLINICAL TRIALS REGISTRATION NCT01751646.
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Feasibility of intervention in elder self-neglecters: Setting the stage for future research.
Lee, JL, Burnett, J, Xia, R, Smith, SM, Dyer, CB
Journal of elder abuse & neglect. 2018;(3):223-235
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Abstract
OBJECTIVES Interventions are critical to improving clinical outcomes in elder self-neglecters. This study assessed feasibility of a randomized controlled trial of oral vitamin D in Adult Protective Services-substantiated self-neglect clients ≥65 years. METHODS Participants were directly observed to consume ergocalciferol 50,000 IU (treatment) or ergocalciferol 400 IU (control), once a month, for 10 months. For months 6-10, half the control group randomly crossed into the treatment group (crossover). Intervention feasibility was measured by number of potential participants who agreed to participate and by retention rates during the study. RESULTS Ninety-four referrals were received and 59 (63%) agreed to participate. Forty-nine participants were enrolled after prescreening and 35 completed the two-phase trial for a 72% retention rate. The participants' average age was 75.2 ± 6.8 years, mainly female (59%), African-American (47%), and living alone (41%). DISCUSSION Despite assumptions that self-neglecters are resistant to care, we have successfully conducted the first clinical intervention in this vulnerable population.
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Can Bisphosphonates Prevent Recurrent Fragility Fractures? A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Lee, SY, Jung, SH, Lee, SU, Ha, YC, Lim, JY
Journal of the American Medical Directors Association. 2018;(5):384-390.e1
Abstract
OBJECTIVES Although a few trials have explored whether bisphosphonates (BPs) prevented recurrent fragility fractures (FFs), little is known about the secondary preventative effects of BPs. Thus, we performed a meta-analysis to examine the effects of BPs on prevention of subsequent fractures, mortality, and on bone metabolic and functional parameters related to FF. We compared BP and control groups. DESIGN A meta-analysis of randomized controlled trials was conducted. SETTING AND PARTICIPANTS Twelve randomized controlled trials that included 5670 participants investigating the effects of BPs following FF were retrieved from PubMed, Embase, and the Cochrane Library. MEASURES We performed a pairwise meta-analysis using fixed- and random-effects models. RESULTS BPs exhibited significant secondary preventative effects after FF compared with controls [overall standardized mean difference = 0.766; 95% confidence interval (CI) 0.493-1.038; P < .001]. The risks of subsequent fracture (odds ratio = 0.499; 95% CI 0.418-0.596; P < .001) and mortality (odds ratio = 0.662; 95% CI 0.511-0.858; P = .002) decreased in the BP groups. Bone mineral density, bone turnover marker levels, pain at the fracture site, and health-related quality of life also differed significantly between the groups. CONCLUSIONS/IMPLICATIONS Our meta-analysis revealed that BPs administered after FF potentially prevented subsequent fractures and reduced mortality. Positive effects in terms of pain, quality of life, and increased bone mineral density and bone metabolism were also verified regardless of the fracture sites and the administration types (oral or intravenous). Therefore, more active BPs use is recommended to prevent recurrent fragility fractures. LEVEL OF EVIDENCE Level I, meta-analysis.
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Clinical characteristics and bisphosphonates treatment of rare pregnancy- and lactation-associated osteoporosis.
Li, LJ, Zhang, J, Gao, P, Lv, F, Song, YW, Chang, XY, Zhao, DC, Wang, O, Jiang, Y, Xing, XP, et al
Clinical rheumatology. 2018;(11):3141-3150
Abstract
Pregnancy- and lactation-associated osteoporosis (PLO) is a rare disorder with poorly known etiology, pathophysiology, and therapy. We aimed to investigate the clinical characteristics of PLO and evaluate the effectiveness and safety of bisphosphonates on it. A total of 12 patients were diagnosed with PLO on the basis of medical history, bone mineral density (BMD), and/or fragility fractures during pregnancy and lactation. We investigated the clinical, biochemical, and radiological characteristics of patients. We assessed the effects of alendronate or zoledronic acid through observing the changes of bone turnover biomarkers and BMD during the treatment. Secondary osteoporosis was excluded by comprehensive differential diagnosis. The mean age of these patients was 31 ± 5 years old. All of these patients presented severe back pain. Multiple vertebral compression fractures (VCFs) were found in 10 patients, and the median (P25th, P75th) number of compressed vertebra was 3 (3, 5). Ten patients had vitamin D insufficiency or deficiency. Serum level of bone resorption marker (β-CTX with mean of 0.68 ± 0.41 ng/ml) was moderately higher than the normal range. BMD at lumbar spine, femoral neck, and total hip were low as 0.894 ± 0.153 g/cm2, 0.728 ± 0.090 g/cm2, and 0.728 ± 0.080 g/cm2, respectively. Either alendronate or zoledronic acid could effectively relieve bone pain, reduce β-CTX level, and increase BMD. PLO is a rare type of osteoporosis, which was characterized by increased bone resorption and decreased BMD, even VCFs. Bisphosphonate therapy was well tolerated and effective in management of PLO, but needed to be further verified in randomized controlled trial.
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Rush Fracture Liaison Service for capturing "missed opportunities" to treat osteoporosis in patients with fragility fractures.
Gupta, MJ, Shah, S, Peterson, S, Baim, S
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2018;(8):1861-1874
Abstract
UNLABELLED In spite of being a public health problem of pandemic proportions, osteoporosis continues to be underdiagnosed and undertreated especially in older adults with fragility fractures. Confirmation of this hypothesis resulted in the development of a novel Fracture Liaison Service (Rush FLS). Results of the first 12 months of operation revealed that patients with confirmed fragility fracture do not have a timely diagnosis at fracture occurrence or treatment of their disease. The Rush FLS is an effective fracture liaison model. INTRODUCTION Determining the prevalence of undiagnosed and untreated osteoporosis in fragility fracture patients, either admitted to an academic tertiary care center or treated and discharged from the center's emergency department to be followed in the endocrinology bone clinic, using an innovative, educational, low-cost, physician-run Fracture Liaison Service (FLS). METHODS An automated alert was integrated into the electronic medical record at Rush University Medical Center (RUMC), triggered by historical and/or acute fracture(s) in patients 50 years or older, in patients that were either admitted to the hospital or in patients evaluated in the emergency department and discharged to be followed in the endocrinology bone clinic. We report the results of the first 12 months of operation in patients admitted to the hospital. RESULTS First acute fragility fracture(s) were identified in 36% (80/223), only historical fragility fracture(s) in 28% (63/223) and both acute and historical fragility fracture(s) in 36% (80/223). The cumulative subgroup with historical fragility fractures with/without new fractures included 67% (96/143) without a previous diagnosis of osteoporosis. First acute fragility fracture group included 83.8% (67/80) without a previous diagnosis of osteoporosis. Rush FLS "captured missed opportunities" in 73.1% (163/223) of previously undiagnosed and 77.1% (172/223) of previously untreated osteoporosis patients. Dual-energy x-ray absorptiometry (DXA) prior to FLS consult was confirmed in 30% (67/223). Vitamin D deficiency (25-hydroxy vitamin D < 20 ng/ml) in 41.9% (78/186) including undetectable levels in 16.6% (31/186) and secondary hyperparathyroidism in 43.3% (78/180) were the most common laboratory confirmed secondary etiologies for bone loss. CONCLUSIONS This study reported undiagnosed, uninvestigated, and untreated osteoporosis in the majority of fragility fracture patients seen by the Rush FLS in the first 12 months of operation.
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Medical optimization of lumbar fusion in the osteoporotic patient.
Morris, MT, Tarpada, SP, Tabatabaie, V, Cho, W
Archives of osteoporosis. 2018;(1):26
Abstract
PURPOSE In patients undergoing lumbar fusion, osteoporosis has been shown to lead to poorer outcomes and greater incidence of fusion-related complications. Given the undesirable effect of osteoporosis on lumbar fusion surgery, a number of medications have been proposed for use in the peri- and postoperative period to mitigate risks and enhance outcomes. The purpose of this review was to summarize and synthesize the current literature regarding medical management of osteoporosis in the context of lumbar fusion surgery. METHODS A literature search of PubMed, Embase, and Web of Science was conducted in October 2016, using permutations of various search terms related to osteoporosis, medications, and lumbar fusion. RESULTS Teriparatide injections may lead to faster, more successful fusion, and may reduce fusion-related complications. Bisphosphonate therapy likely does not hinder fusion outcomes and may be useful in reducing certain complications of fusion in osteoporotic patients. Calcitonin and selective estrogen receptor modulator therapy show mixed results, but more research is necessary to make a recommendation. Vitamin D deficiency is associated with poor fusion outcomes, but evidence for supplementation in patients with normal serum levels is weak. CONCLUSIONS Overall, the current body of research appears to support the use of teriparatide therapy to enhance lumbar fusion outcomes in the osteoporotic patient, although the extent of research on this topic is limited. Additionally, very little evidence exists to cease any of the mentioned osteoporosis treatments prior to lumbar fusion.
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[Utilization of alfacalcidol and active vitamin D analogs in chronic kidney disease].
Ureña-Torres, PA, Cozzolino, M, Bover, J
Nephrologie & therapeutique. 2018;(4):189-200
Abstract
Secondary hyperparathyroidism (SHPT) is one of the most frequent and deleterious complication of chronic kidney disease (CKD). SHPT is also one of the principal components of the now called CKD-mineral and bone disorders (MBD) syndrome. It is usually prevented and treated by vitamin D derivatives. However, the rationale for the prescription of vitamin D sterols in those patients is still a matter of hotly debates, mainly because of unsatisfactory results from numerous observational and not well-controlled studies. Scanty clinical data on head-to-head comparisons between the multiple vitamin D sterols are currently available. Moreover, there is crescent expectations on nutritional vitamin D, as well as vitamin D receptor activators (VDRA), regarding their putative pleiotropic effects even in CKD patients, and the promising effects of VDRA against proteinuria and myocardial hypertrophy in diabetic CKD cohorts. Nevertheless, additional randomized controlled trials (RCT) are needed to answer to many open questions and incertitude considering the effect of nutritional vitamin D and VDRA on hard end points including the risk of skeletal fractures and of mortality in CKD patients. RCT comparing VDRA to calcimimetics in the control of SHPT are also needed in dialysis patients. The present review will visit these open questions that nephrologists should ask before starting a treatment by nutritional vitamin D or VDRA.
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Clinical characteristics associated with bone mineral density improvement after 1-year alendronate/vitamin d3 or calcitriol treatment: Exploratory results from a phase 3, randomized, controlled trial on postmenopausal osteoporotic women in China.
Liao, EY, Zhang, ZL, Xia, WB, Lin, H, Cheng, Q, Wang, L, Hao, YQ, Chen, DC, Tang, H, Peng, YD, et al
Medicine. 2018;(31):e11694
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Baseline and on-treatment characteristics, including age, obesity, calcium intake, and bone turnover markers, may predict the bone mineral density (BMD) response in women with postmenopausal osteoporosis (PMO) to 1 to 2 years of antiresorptive therapy and/or vitamin D supplementation. This study aimed to explore clinical characteristics associated with 12-month BMD improvement in Chinese women with postmenopausal osteoporosis (PMO).In this post hoc analysis of a previous phase 3 multicenter, randomized controlled trial, Chinese PMO women who were treated with once weekly alendronate 70 mg/vitamin D3 5600 IU (ALN/D5600) or once daily calcitriol 0.25 mcg, and had measurements of 1-year lumbar spine BMD (LS-BMD) and on-treatment bone turnover markers (BTMs) were included in the analysis.In Chinese PMO patients on ALN/D5600, 1-year LS-BMD change was negatively correlated with age (β = -0.00084, P < .01), dietary calcium (β = -0.0017, P = .07), and procollagen type 1 N-terminal propeptide (P1NP) change at month 6 (β = -0.000469, P = .0016), but positively with body mass index (BMI) (β = 0.00128, P = .08); baseline P1NP above the median was associated with a significantly greater BMD percentage change at the lumbar spine (P = .02) and the total hip (P = .0001). In the calcitriol group, a significant 1-year LS-BMD increase was associated with BMI (β = 0.0023, P = .02), baseline P1NP (β = 0.00035, P = .0067), history of prior vertebral fracture(s) (β = 0.034, P < .0001) and baseline serum 25(OH)D level (β = -0.00083, P = .02).The presented findings from Chinese postmenopausal osteoporotic women suggested clinically meaningful baseline and on-treatment characteristics predicting BMD improvement after 1 year of ALN/D5600 treatment, which differed from calcitriol treatment with baseline identifiable associations. The study remained exploratory and further accumulation of evidence is needed.
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[Bone and calcium metabolism associated with malignancy. Bone metastasis of prostate cancer:overview of clinical features and treatments.].
Suzuki, K, Miyazawa, Y
Clinical calcium. 2018;(11):1441-1449
Abstract
Bones are the most frequent sites in patients with progressive prostate cancer. Spinal column and pelvic bone are vulnerable for metastasis, and osteoblastic lesions are frequently observed. Imaging evaluation is performed using bone scintigrapy with 99mTc, CT or MRI. Extent of disease is categorized as EOD score, and it is still used for evaluation of bone metastasis in clinical trials. Clinical guidelines recommend the uses of bone modifying agents including zoledronic acid and denosumab for bone metastasis in patients with castration-resistant prostate cancer. New androgen targeted agents, enzalutamide and abiraterone, or taxans, docetaxel and cabazitaxel, show clinical efficacy for bone metastasis of prostate cancer. Recently, metastasis free survival(MFS)has been approved as a primary endpoint for nonmetastatic castration-resistant prostate cancer. For this category, enzalutamide and apalutamide have been approved for patients with nonmetastatic castration-resistant prostate cancer. Treatment and follow-up strategy is now dramatically changed in the area of bone metastasis of prostate cancer.
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Treatment of Hypovitaminosis D in an Orthopaedic Trauma Population.
Andres, BA, Childs, BR, Vallier, HA
Journal of orthopaedic trauma. 2018;(4):e129-e133
Abstract
OBJECTIVES To determine the incidence of hypovitaminosis D and to evaluate a supplementation intervention. We hypothesized that patients would exhibit high adherence with a free sample, and levels would become sufficient. DESIGN Prospective observational study. SETTING Level 1 trauma center. PATIENTS One hundred forty-four consecutive, skeletally mature patients treated for acute fractures. INTERVENTION All were provided 600 mg calcium and 800 IU vitamin D3 capsules twice daily. MAIN OUTCOME MEASUREMENTS Serum 25(OH) D levels were obtained on presentation and after supplementation. Patient surveys determined adherence, vitamin D intake, and sun exposure. RESULTS Ninety-one men and 53 women, mean age 45 years, mean body mass index 28.1, were studied. Mean baseline 25(OH) D level was 20.2 ng/mL, including 9 patients taking vitamin D supplements before injury. All others (mean baseline 16.9 ng/mL) were prescribed calcium and vitamin D and were offered free supplements when discharged. Seventy-seven patients completed surveys, and mean 25(OH) D level was 36.7 ng/mL after a mean of 7.0 weeks of supplementation (P < 0.0001). Seventy-nine percent reported adherence to supplement recommendations. All adherent patients achieved normal levels. Sixteen patients were nonadherent, with 10 who forgot to take the supplement, 4 choosing not to use it, 1 choosing to sell the sample, and 1 losing the sample. CONCLUSION Hypovitaminosis D was present in 97% of orthopaedic trauma patients who were not already taking supplements. The intervention was effective in reducing hypovitaminosis D within several weeks, with all supplemented patients achieving normal levels. Seventy-nine percent of patients adhered to recommendations. Further study to determine the long-term cost-effectiveness of this strategy seems warranted. LEVEL OF EVIDENCE Therapeutic, Level II. See Instructions for Authors for a complete description of levels of evidence.