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Comparison of the Effects of Native Vitamin D and Eldecalcitol on Muscular Strength and Dynamic Balance in Patients with Postmenopausal Osteoporosis

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Comparison of the Effects of Native Vitamin D and Eldecalcitol on Muscular Strength and Dynamic Balance in Patients with Postmenopausal Osteoporosis doi: 10.2490/prm.20200026 Progress in Rehabilitation Medicine 2020; Vol. 5, 20200026 ORIGINAL ARTICLE Comparison of the Effects of Native Vitamin D and Eldecalcitol on Muscular Strength and Dynamic Balance in Patients with Postmenopausal Osteoporosis Naohisa Miyakoshi, MD, PhD Norimitsu Masutani, MD, PhD Yuji Kasukawa, MD, PhD Daisuke Kudo, MD, PhD Kimio Saito, MD, PhD Toshiki Matsunaga, MD, PhD and Yoichi Shimada, MD, PhD Objectives: Previous studies have suggested that the effects of vitamin D in preventing osteopo- rotic fractures result in part from its influence on fall prevention. However, the effects of vitamin D on dynamic balance as a contributor to fall prevention have not been fully evaluated. Moreover, few studies have compared the effects of native and active forms of vitamin D. The objective of this preliminary randomized prospective study was to compare the effects of native vitamin D and eldecalcitol on muscular strength and dynamic balance in postmenopausal patients undergo- ing denosumab treatment for osteoporosis. Methods: A total of 30 women with postmenopausal osteoporosis were randomly assigned to a native D group (administered denosumab and native vitamin D with calcium) or an ELD group (administered denosumab and eldecalcitol) and were followed up for 6 months. The following parameters were compared: the strengths of the back extensor and lower extremity muscles; static balance evaluated using the one-leg standing test; and dynamic balance evaluated using the 10-m walk test, the functional reach test, the timed up and go test, and the total length of the trajectory of the center of gravity (LNG) measured using a dynamic sitting balance measurement device. Results: Compared to baseline measurements, back extensor and knee extensor strengths had significantly increased after 6 months of treatment in the native D group (P<0.05) but not in the ELD group. In contrast, LNG significantly improved in both groups after 6 months (P<0.05). No significant differences between the two groups were seen in any of these measured parameters after treatment. Conclusions: Both native vitamin D + denosumab and eldecalcitol + denosumab were effective for improving dynamic sitting balance in postmenopausal women with osteoporosis. Key Words: balance; eldecalcitol; muscle strength; osteoporosis; vitamin D INTRODUCTION resentative methods of measuring static balance include the one-leg standing test (OLS) and the standing center-of-grav- Most osteoporotic fractures in the elderly are caused by ity examination,2) whereas dynamic balance in the elderly is falls. Because impairment of balance and muscle weakness commonly evaluated using the timed up and go test (TUG)3) are the major risk factors for falls in the elderly,1) the assess- and the functional reach test (FRT).4) ment of muscle strength and balance are central to evaluating In regard to falls, the assessment of dynamic balance is the tendency to fall and to instigating preventive measures considered to be more important than that of static balance. against falls. When assessing balance, we should consider Many falls are caused by sudden external stimuli such as dynamic balance as well as static balance. Clinically, rep- slipping or tripping5); falls arising as a consequence of bal- Received: July 20, 2020, Accepted: October 14, 2020, Published online: October 30, 2020 Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan Correspondence: Naohisa Miyakoshi, MD, PhD, Department of Orthopedic Surgery, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita 010-8543, Japan, E-mail: [email protected] Copyright © 2020 The Japanese Association of Rehabilitation Medicine This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND) 4.0 License. http://creativecommons.org/licenses/by-nc-nd/4.0/ 1 2 Miyakoshi N, et al: Effects of Vitamin D on Dynamic Balance ance dysfunction are more closely related to the ability to Mineral Research (2012 revision).18) Briefly, patients with: respond to external stimuli and dynamic balance than to (1) fragility fracture in either the lumbar spine or proximal maintaining a static posture.6) We therefore developed a de- femur; (2) other fragility fracture and BMD <80% of the vice for measuring dynamic balance in the sitting position. young adult mean (YAM); or (3) BMD ≤70% or −2.5 stan- The device is capable of measuring trunk balance ability by dard deviations below the YAM were diagnosed as having adding a disturbance that periodically tilts the seat surface osteoporosis. in the frontal plane; we have previously reported its utility in Subjects with comorbidities such as gastrectomy; renal balance evaluation.7–9) Dynamic balance evaluation with the failure; or bone diseases such as cancer-induced bone loss, subject in the sitting position is safer than other positions for primary hyperparathyroidism, hyperthyroidism, Cushing’s assessing balance in elderly individuals at risk of falls. syndrome, multiple myeloma, Paget’s disease of the bone, Studies have shown that vitamin D, an essential hormone or osteogenesis imperfecta were excluded from this study. for bone health, exerts positive effects on balance and muscle Subjects with the following conditions who could have neu- strength and is effective in preventing falls, especially in the romuscular or musculoskeletal diseases were also excluded elderly.10–13) However, much of the clinical research into the because of the increased risk of falls: dementia, Parkinson’s effects of vitamin D regarding fall prevention has been done disease, cranial nerve disorders, spinal cord disorders, anti- 10–13) using native vitamin D with calcium supplementation, psychotic drug usage, or severe osteoarthritis of the knee. whereas research into active vitamin D3, including eldecal- Subjects were randomly allocated to either the native D citol [2β-(3-hydroxypropyloxy)-1,25-dihydroxyvitamin D3], group (n=15) or the ELD group (n=15). In the native D group, remains insufficient. patients were treated with denosumab (60 mg subcutaneous- Among many anti-osteoporotic agents, denosumab, a ly every 6 months) in combination with orally administered human monoclonal antibody against receptor activator of cholecalciferol at 400 IU/day (10 µg/day) and calcium at nuclear factor κ-B ligand, is used worldwide as one of the 610 mg/day (Denotas; Daiichi Sankyo, Tokyo, Japan). In the most effective agents. Denosumab selectively inhibits os- ELD group, patients were treated with denosumab (60 mg teoclastogenesis and exerts potent inhibitory effects on bone subcutaneous injection every 6 months) in combination turnover, thereby increasing bone mineral density (BMD) with orally administered eldecalcitol at 0.75 µg/day (Edirol; and preventing osteoporotic fractures.14–17) In Japan, to pre- Chugai Pharmaceutical Co., Tokyo, Japan). We used the vent hypocalcemia resulting from denosumab treatment, use RAND function in Excel to randomize the subjects. Enrolled of the insurance-covered chewable tablet of native vitamin D subjects with a RAND value of less than 0.5 were assigned with calcium supplementation is recommended. However, in to the native D group, whereas those with a RAND value of clinical practice, active vitamin D3, including eldecalcitol, is more than 0.5 were allocated to the ELD group. In the ELD also used with denosumab. Consequently, the purpose of this group, to minimize the risk of hypercalcemia (in accordance open-label, prospective, randomized study was to compare with the warning given in the drug package insert for el- the effects of native vitamin D with calcium supplementation decalcitol), calcium supplementation was not administered; and eldecalcitol on balance (both dynamic and static) and however, active intake of dietary calcium was not prohibited. muscle strength in postmenopausal patients undergoing de- During the 6-month treatment period, nine patients nosumab treatment for osteoporosis. This preliminary study dropped out of the study. The reasons were cessation of examined the effects of native vitamin D and eldecalcitol in hospital visits for any reason (1 patient in the native D group, a limited number of subjects. 3 patients in the ELD group), numbness in the extremities (1 patient in the native D group, 3 patients in the ELD group), METHODS or withdrawn consent (1 subject in the ELD group). Con- sequently, data from 21 subjects (13 patients in the native Patients and Study Design D group, 8 patients in the ELD group) were included in the A total of 30 women (≥60 years old) with postmenopausal final analyses (Fig. 1). The protocol for this randomized pro- osteoporosis, no history of treatment for osteoporosis, and spective study was approved by the ethics committee at our in whom measuring physical function parameters was fea- institute (approval no. 1188), and the study was conducted at sible, were recruited to this open-label, prospective, 6-month Oga-Minato General Hospital. Written informed consent for randomized study. Osteoporosis was diagnosed according to the study and publication of its results was obtained from all the criteria proposed by the Japanese Society for Bone and patients. Copyright © 2020 The Japanese Association of Rehabilitation Medicine Prog. Rehabil. Med. 2020; Vol.5, 20200026 3 Fig. 1. Flowchart depicting the steps involved in the recruitment process. BMD, bone mineral density. Evaluations significant change for this measurement modality
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