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A New Active Vitamin D, ED-71, Increases Bone Mass in Osteoporotic Patients under Vitamin D Supplementation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Department of Medicine and Bioregulatory Sciences (T.Ma.), University of Tokushima Graduate School of Health Biosciences, Tokushima 770-8503, Japan; Osaka City University (T.Mi.), Osaka 545-0051, Japan; Tottori University (H.H.), Tottori 683-0826, Japan; Kobe University (T.S.), Kobe 650-0017, Japan; Sanyo Osteoporosis Research Foundation (S.O.) Oita 870-0924, Japan; Tsuji Academy of Nutrition (T.H.), Osaka 530-0021, Japan; Keio University Hospital (Y.T.), Tokyo 160-8582, Japan; Tokyo Metropolitan Geriatric Hospital (Y.H.), Tokyo 173-0015, Japan; Kawasaki Medical School (M.F.), Kurashiki 701-0192, Japan; Research Institute and Practice for Involutional Diseases (M.S.), Nagano 399-8101, Japan; and University of Occupational and Environmental Health (T.N.), Fukuoka 807-8582, Japan

Address all correspondence and requests for reprints to: Toshio Matsumoto, M.D., Department of Medicine and Bioregulatory Sciences, University of Tokushima Graduate School of Health Biosciences, 3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan. E-mail: toshimat{at}clin.med.tokushima-u.ac.jp.

Context: ED-71 has been shown to increase lumbar bone mineral density (BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED-71 on BMD.

Objective: Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D supplementation.

Design, Setting, and Patients: We conducted a randomized, double-blind, placebo-controlled clinical trial of 219 osteoporotic patients (49–87 yr of age).

Interventions: Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 µg/d ED-71 for 12 months. All the subjects received 200 or 400 IU/d vitamin D₃.

Main outcome measures: We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.

Results: Lumbar BMD increased with ED-71 treatment for 12 months (2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 µg ED-71, respectively). Total hip BMD also increased with 0.75 and 1.0 µg ED-71 (–0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 µg ED-71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 µg ED-71 treatment. Transient hypercalcemia over 2.6 mmol/liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 µg ED-71 groups, respectively, but none of them developed sustained hypercalcemia.

Conclusions: These results demonstrate that ED-71 treatment at around 0.75 µg/d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation.