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The effect of magnetic therapy and moderate aerobic exercise on osteoporotic patients: A randomized clinical study.
Eid, MM, El-Gendy, AM, Abdelbasset, WK, Elkholi, SM, Abdel-Fattah, MS
Medicine. 2021;(39):e27379
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BACKGROUND Osteoporosis is a frequent musculoskeletal condition with significant complications that would be a global health problem and one of the major causes of mortality and morbidity. OBJECTIVES The current study aimed to ascertain the impact of pulsed magnetic therapy, aerobic exercise, and a combination of both modalities on osteoporotic female patients postthyroidectomy. METHODS Between May 2018 and September 2019, 45 female patients with osteoporosis were included in the randomized clinical study, their age ranged from 40 to 50 years, had thyroidectomy for at least 6 months ago, and had an inactive lifestyle for at least the previous 6 months. Patients were assigned randomly into 3 equal groups. Group A (magnetic therapy group): received routine medical treatment (bisphosphonates, calcium, and vitamin D) in addition to pulsed magnetic therapy on the hip region for 12 weeks (3 sessions/week). Group B (exercise group): received routine medical treatment plus moderate-intensity aerobic exercise for 12 weeks (3 sessions/week). Group C (combined magnetic therapy and exercise therapy group): received routine medical treatment plus pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks (3 sessions/week). The 3 groups were assessed for bone mineral density (BMD) at baseline by dual-energy x-ray absorptiometry and after 12 weeks of treatment. RESULTS The results showed that within-group analysis a statistically significant increase was reveled (P < .05) for BMD in the 3 studied groups. Comparing the results among the 3 tested groups revealed a significant increase (P < .05) in posttesting mean values of BMD in group (C) compared to group (A) and group (B). No significant statistical difference in BMD means values between the 2 groups (A) and (B) after testing was detected. CONCLUSION Combination of both pulsed magnetic therapy and moderate-intensity aerobic exercise showed significant improvement in BMD at the hip region than using any of the 2 modalities alone.
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Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial.
Sales, LP, Pinto, AJ, Rodrigues, SF, Alvarenga, JC, Gonçalves, N, Sampaio-Barros, MM, Benatti, FB, Gualano, B, Rodrigues Pereira, RM
The journals of gerontology. Series A, Biological sciences and medical sciences. 2020;(5):931-938
Abstract
BACKGROUND Creatine supplementation could be a nonexpensive, safe, and effective dietary intervention to counteract bone loss. The aim of this study was to investigate whether long-term creatine supplementation can improve bone health in older, postmenopausal women. METHODS A double-blind, placebo-controlled, parallel-group, randomized trial was conducted between November 2011 and December 2017 in Sao Paulo, Brazil. Two hundred postmenopausal women with osteopenia were randomly allocated to receive either creatine monohydrate (3 g/d) or placebo for 2 years. At baseline and after 12 and 24 months, we assessed areal bone mineral density (aBMD; primary outcome), lean and fat mass (through dual X-ray absorptiometry), volumetric BMD and bone microarchitecture parameters, biochemical bone markers, physical function and strength, and the number of falls and fractures. Possible adverse effects were self-reported. RESULTS Lumbar spine (p < .001), femoral neck (p < .001), and total femur aBMD (p = .032) decreased across time; however, no interaction effect was observed (all p > .050). Bone markers, microarchitecture parameters, and the number of falls/fractures were not changed with creatine (all p > .050). Lean mass and appendicular skeletal muscle mass increased throughout the intervention (p < .001), with no additive effect of creatine (p = .731 and p = .397, respectively). Creatine did not affect health-related laboratory parameters. CONCLUSION Creatine supplementation more than 2 years did not improve bone health in older, postmenopausal women with osteopenia, nor did it affect lean mass or muscle function in this population. This refutes the long-lasting notion that this dietary supplement alone has osteogenic or anabolic properties in the long run. CLINICAL TRIAL REGISTRY Clinicaltrials.gov: NCT: 01472393.
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Fall Prevention and Anti-Osteoporosis in Osteopenia Patients of 80 Years of Age and Older: A Randomized Controlled Study.
Zhou, J, Liu, B, Qin, MZ, Liu, JP
Orthopaedic surgery. 2020;(3):890-899
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UNLABELLED To evaluate the effects of two fall-prevention and anti-osteoporotic protocols in elderly patients with osteopenia (OPA). METHODS The present randomized controlled study included patients with OPA (n =123). The age of these patients was ≥80 years old, with the mean age of 83.54 ± 2.99 years, and the male-to-female ratio was 2.97:1.00. Fall-prevention guidance was given to all patients. Patients in the experiment group (n = 62) orally received 600 mg/d of calcium carbonate, 0.5 μg/d of alfacalcidol, and 70 mg/week of alendronate, while patients in the control group (n = 61) orally received 600 mg/d of calcium carbonate and 0.5 μg/d of alfacalcidol for 18 months. The grip strength, gait speed, bone turnover markers, serum calcium, serum phosphorus, parathyroid hormone (PTH), and bone mineral density were measured, and the Timed Up and Go (TUG) test and the chair rising test (CRT) were performed. Falls, fragility fractures, medication compliance, and side effects of the drugs were recorded. RESULTS The serum levels of bone turnover markers (type I procollagen amino-terminal peptide [P1NP], type I collagen carboxyl terminal peptide [β-CTx], and osteocalcin [OC]) decreased, while the bone mineral density of the lumbar spine and bilateral femoral neck increased after treatment in the experiment group (P < 0.05, P < 0.01). The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01). After treatment, the proportion of patients with increased hip T scores in the experiment group (66.1%, 41/62) was significantly higher than the proportion (35.0%, 21/60) in the control group (P = 0.001). The incidence of fall decreased in both groups after treatment compared to that before treatment (54.8% vs 33.9% and 54.1% vs 36.7%, respectively; P < 0.05). The incidence of fragility fractures was lower in the experiment group than the control group (8.1% vs 20.0%, P = 0.057). During the intervention period, the incidence of fragility fractures in patients who did not fall (3.8%, 3/79) was significantly lower than that in patients who fell (32.6%, 14/43) (P = 0.000). The risk of fragility fractures was significantly lower in patients who did not fall compared to patients who fell (relative risk: 0.117, 95% confidence interval: 0.035-0.384). CONCLUSION The combination of alendronate sodium with alfacalcidol and calcium can significantly improve the bone mineral density of the lumbar spine and femoral neck. For older patients with OPA, subjectively paying attention to avoiding falls can significantly reduce the risk of fragility fractures.
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The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study.
Takács, I, Jókai, E, Kováts, DE, Aradi, I
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2019;(3):675-683
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UNLABELLED To demonstrate the clinical comparability between RGB-10 (a biosimilar teriparatide) and the originator, a comparative pharmacokinetic trial was conducted. The study was successful in establishing bioequivalence. Marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency in 2017. INTRODUCTION Teriparatide, the first bone anabolic agent, is the biologically active fragment of human parathyroid hormone. The imminent patent expiry of the originator will open the door for biosimilars to enter the osteology market, thereby improving access to a highly effective, yet prohibitively expensive therapy. METHODS Subsequent to establishing comparability on the quality and non-clinical levels between RGB-10, a biosimilar teriparatide, and its reference product (Forsteo®), a randomised, double-blind, 2-way cross-over comparative study (duration: four days) was conducted in 54 healthy women (ages: 18 to 55 years) to demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence and comparable safety of these products. Extents of exposure (AUC0-tlast) and peak exposure (Cmax), as measured by means of ELISA, were evaluated as co-primary PK endpoints, and serum calcium levels, as measured using standard automated techniques, were assessed for PD effects. Safety was monitored throughout the study. RESULTS The 94.12% CIs for the ratio of the test to the reference treatments, used due to the two-stage design (85.20-98.60% and 85.51-99.52% for AUC0-tlast and Cmax, respectively), fell within the 80.00-125.00% acceptance range. The calcium PD parameters were essentially identical with geometric mean ratios (GMRs) of 99.93% and 99.87% for AUC and Cmax, respectively. Analysis of the safety data did not reveal any differences between RGB-10 and its reference. CONCLUSION Based on the high level of similarity in the preclinical data and the results of this clinical study, marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency (EMA) in 2017.
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Long-Term Ultra-High Hydrostatic Pressurized Brown Rice Intake Prevents Bone Mineral Density Decline in Elderly Japanese Individuals.
Matsuzaki, K, Yano, S, Sumiyoshi, E, Shido, O, Katsube, T, Tabata, M, Okuda, M, Sugimoto, H, Yoshino, K, Hashimoto, M
Journal of nutritional science and vitaminology. 2019;(Supplement):S88-S92
Abstract
Bone embrittlement with aging, namely osteoporosis, is characterized by low bone mass and deterioration of bone tissue, and can lead to increased risk of fracture. The development of functional foods that can prevent geriatric diseases is in progress. Our focus was on brown rice because of its properties. An interventional study using of ultra-high hydrostatic pressurized brown rice (UHHPBR) for human has not yet been conducted. In this study, we investigated whether long-term dietary intake of UHHPBR prevents aging-related decline of bone mineral density in elderly Japanese individuals. Elderly participants (n=40; mean 73.1 y) in Iinan-cho, Shimane, Japan, were randomly divided into two groups. The UHHPBR-intake group (n=20) consumed 100 g of UHHPBR and 100 g of white rice (WR) per day for 12 mo, while the WR-intake group (n=20) consumed 200 g of WR per day. Pre- and 12-mo post-intervention, bone mineral density was evaluated by quantitative ultrasound. After 12 mo of intervention, the UHHPBR group's bone mineral density was significantly higher than the WR group's bone mineral density. Moreover, chronic intake of UHHPBR had no adverse side effects on participants. Long-term oral UHHPBR intake may have beneficial effects on bone mineral density decline and may attenuate osteoporosis in the elderly.
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The effect of educational text message based on health belief model on osteoporosis preventive behaviors in women: a randomized controlled clinical trial.
Parandeh, L, Shafaie, FS, Malakouti, J, Mirghafourvand, M, Asghari-Jafarabadi, M
Women & health. 2019;(10):1128-1140
Abstract
The purpose of this study was to investigate the effect of educational text messages, based on the health belief model, on osteoporosis preventive behaviors among women aged 30-45 years. This trial was conducted on 121 women from November until September 2017 in Shabestar, Iran. The intervention group received a daily educational text message about osteoporosis for one month, and the control group received educational text messages on frequently occurring cancers in women. Two months after the training, data were collected using the osteoporosis health belief scale, a food frequency questionnaire and the International Physical Activity Questionnaire. No significant differences were observed at baseline between the two groups, except for the perceived benefits construct. After the intervention, controlling for baseline score and adjusting for educational level, a statistically significant difference was observed between the two groups in HBM structures and nutrition performance, while no significant difference was observed in physical activity between the two groups. This study showed that educational text messages can be effective in increasing awareness, perceived susceptibility and severity, and nutritional behavior change related to risk of osteoporosis.
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Effect of two prophylactic bolus vitamin D dosing regimens (1000 IU/day vs. 400 IU/day) on bone mineral content in new-onset and infrequently-relapsing nephrotic syndrome: a randomised clinical trial.
Muske, S, Krishnamurthy, S, Kamalanathan, SK, Rajappa, M, Harichandrakumar, KT, Sivamurukan, P
Paediatrics and international child health. 2018;(1):23-33
Abstract
OBJECTIVES To examine the efficacy of two vitamin D dosages (1000 vs. 400 IU/day) for osteoprotection in children with new-onset and infrequently-relapsing nephrotic syndrome (IFRNS) receiving corticosteroids. METHODS This parallel-group, open label, randomised clinical trial enrolled 92 children with new-onset nephrotic syndrome (NS) (n = 28) or IFRNS (n = 64) to receive 1000 IU/day (Group A, n = 46) or 400 IU/day (Group B, n = 46) vitamin D (administered as a single bolus initial supplemental dose) by block randomisation in a 1:1 allocation ratio. In Group A, vitamin D (cholecalciferol in a Calcirol® sachet) was administered in a single stat dose of 84,000 IU on Day 1 of steroid therapy (for new-onset NS), calculated for a period of 12 weeks@1000 IU/day) and 42,000 IU on Day 1 of steroid therapy (for IFRNS, calculated for a period of 6 weeks@1000 IU/day). In Group B, vitamin D (cholecalciferol in a Calcirol® sachet) was administered as a single stat dose of 33,600 IU on Day 1 of steroid therapy (for new-onset NS, calculated for a period of 12 weeks@400 IU/day) and 16,800 IU on Day 1 of steroid therapy (for IFRNS, calculated for a period of 6 weeks@400 IU/day). The proportionate change in bone mineral content (BMC) was analysed in both groups after vitamin D supplementation. RESULTS Of the 92 children enrolled, 84 (n = 42 new onset, n = 42 IFRNS) completed the study and were included in the final analysis. Baseline characteristics including initial BMC, bone mineral density, cumulative prednisolone dosage and serum 25-hydroxycholecalciferol levels were comparable in the two groups. There was a greater median proportionate change in BMC in the children who received 1000 IU/day vitamin D (3.25%, IQR -1.2 to 12.4) than in those who received 400 IU/day vitamin D (1.2%, IQR -2.5 to 3.8, p = 0.048). The difference in proportionate change in BMC was only statistically significant in the combined new-onset and IFRNS, but not for IFRNS alone. There was a greater median proportionate change in serum 25-hydroxycholecalciferol, in the children who received 1000 IU/day vitamin D (20.6%, IQR 14.9-36.75) than in those who received 400 IU/day vitamin D (7.7%, IQR 3.5-18.5, p < 0.01). There was a greater median proportionate change in serum calcium in the children who received 1000 IU/day vitamin D (20%, IQR 13.1-29.0) than in those who received 400 IU/day vitamin D (11.3%, IQR 2.8-25.0, p = 0.03). Despite vitamin D therapy, BMC decreased from the baseline in 15 (32.6%) children receiving 1000 IU/day vitamin D and in 17 (36.9%) children receiving 400 IU/day vitamin D. There were no adverse effects attributable to vitamin D. CONCLUSION The 1000 IU/day dose is marginally more effective than 400 IU/day and it is likely than an even larger dose is required. Further research is required to assess the efficacy and safety of vitamin D doses higher than 1000 IU/day.
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Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial.
Danila, MI, Outman, RC, Rahn, EJ, Mudano, AS, Redden, DT, Li, P, Allison, JJ, Anderson, FA, Wyman, A, Greenspan, SL, et al
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2018;(5):763-772
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Osteoporosis treatment rates are declining, even among those with past fractures. Novel, low-cost approaches are needed to improve osteoporosis care. We conducted a parallel group, controlled, randomized clinical trial evaluating a behavioral intervention for improving osteoporosis medication use. A total of 2684 women with self-reported fracture history after age 45 years not using osteoporosis therapy from US Global Longitudinal Study of Osteoporosis in Women (GLOW) sites were randomized 1:1 to receive a multimodal, tailored, direct-to-patient, video intervention versus usual care. The primary study outcome was self-report of osteoporosis medication use at 6 months. Other outcomes included calcium and vitamin D supplementation, bone mineral density (BMD) testing, readiness for behavioral change, and barriers to treatment. In intent-to-treat analyses, there were no significant differences between groups (intervention versus control) in osteoporosis medication use (11.7% versus 11.4%, p = 0.8), calcium supplementation (31.8% versus 32.6%, p = 0.7), vitamin D intake (41.3% versus 41.9%, p = 0.8), or BMD testing (61.8% versus 57.1%, p = 0.2). In the intervention group, fewer women were in the precontemplative stage of behavior change, more women reported seeing their primary care provider, had concerns regarding osteonecrosis of the jaw, and difficulty in taking/remembering to take osteoporosis medications. We found differences in BMD testing among the subgroup of women with no prior osteoporosis treatment, those who provided contact information, and those with no past BMD testing. In per protocol analyses, women with appreciable exposure to the online intervention (n = 257) were more likely to start nonbisphosphonates (odds ratio [OR] = 2.70; 95% confidence interval [CI] 1.26-5.79) compared with the usual care group. Although our intervention did not increase the use of osteoporosis therapy at 6 months, it increased nonbisphosphonate medication use and BMD testing in select subgroups, shifted participants' readiness for behavior change, and altered perceptions of barriers to osteoporosis treatment. Achieving changes in osteoporosis care using patient activation approaches alone is challenging. © 2018 American Society for Bone and Mineral Research.
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The relationship of Physical performance and Osteoporosis prevention with vitamin D in older African Americans (PODA).
Dhaliwal, R, Mikhail, M, Usera, G, Stolberg, A, Islam, S, Ragolia, L, Aloia, JF
Contemporary clinical trials. 2018;:39-45
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RATIONALE Vitamin D deficiency is associated with bone loss, poor muscle strength, falls and fracture. This information in older African Americans (AAs) is sparse. OBJECTIVE The study of the relationship of Physical performance, Osteoporosis prevention with vitamin D in older African Americans (PODA) is a randomized, double-blind, placebo-controlled 3-year trial examining the effect of vitamin D on bone loss and physical performance in older AA women. METHODS 260 healthy AA women aged >60years were assigned to receive placebo or vitamin D3. Initial vitamin D3 dose was determined by the baseline serum 25OHD level, and adjusted further to maintain serum 25OHD between 30 and 69ng/ml. Subjects with baseline 25OHD levels ≤8ng/ml or ≥26ng/ml were excluded. Objective measures of neuromuscular strength [Short Physical Performance Battery (SPPB), grip strength and 6-minute walking distance (6MWD)] and bone mineral density (BMD) were obtained. RESULTS SPPB gait speed, grip strength and 6MWD showed a significant positive correlation with free 25OHD. 1pg/ml increase in free 25OHD predicted a 32% increase in the odds of having higher gait speed and a 1.42lb. increase in grip strength. No significant differences in BMI, BMD, muscle mass, grip strength, serum total 25OHD and free 25OHD were observed between groups. None of the measures of physical performance showed an association with baseline serum 25OHD. CONCLUSIONS This is the first study to show an association between free 25OHD and physical performance. These findings indicate a positive relationship of free 25OHD with gait speed and grip strength in older AA women. Further studies are needed to understand the role of free 25OHD.
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Racial Differences and Disparities in Osteoporosis-related Bone Health: Results From the PAADRN Randomized Controlled Trial.
Cram, P, Saag, KG, Lou, Y, Edmonds, SW, Hall, SF, Roblin, DW, Wright, NC, Jones, MP, Wolinsky, FD, ,
Medical care. 2017;(6):561-568
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BACKGROUND Determining whether observed differences in health care can be called disparities requires persistence of differences after adjustment for relevant patient, provider, and health system factors. We examined whether providing dual-energy x-ray absorptiometry (DXA) test results directly to patients might reduce or eliminate racial differences in osteoporosis-related health care. DESIGN, SUBJECTS, AND MEASURES We analyzed data from 3484 white and 1041 black women who underwent DXA testing at 2 health systems participating in the Patient Activation after DXA Result Notification (PAADRN) pragmatic clinical trial (ClinicalTrials.gov NCT-01507662) between February 2012 and August 2014. We examined 7 outcomes related to bone health at 12 weeks and 52 weeks post-DXA: (1) whether the patient correctly identified their DXA baseline results; (2) whether the patient was on guideline-concordant osteoporosis pharmacotherapy; (3) osteoporosis-related satisfaction; (4) osteoporosis knowledge; (5 and 6) osteoporosis self-efficacy for exercise and for diet; and (7) patient activation. We examined whether unadjusted differences in outcomes between whites and blacks persisted after adjusting for patient, provider, and health system factors. RESULTS Mean age was 66.5 years and 29% were black. At baseline black women had less education, poorer health status, and were less likely to report a history of osteoporosis (P<0.001 for all). In unadjusted analyses black women were less likely to correctly identify their actual DXA results, more likely to be on guideline-concordant therapy, and had similar patient activation. After adjustment for patient demographics, baseline health status and other factors, black women were still less likely to know their actual DXA result and less likely to be on guideline-concordant therapy, but black women had greater patient activation. CONCLUSIONS Adjustment for patient and provider level factors can change how racial differences are viewed, unmasking new disparities, and providing explanations for others.