Alfacalcidol Increases the Therapeutic Efficacy of Ibandronate on Bone Mineral Density in Japanese Women with Primary Osteoporosis
Bisphosphonates (BPs) increase bone mineral density (BMD) through the inhibition of osteoclast activity. Among BPs, ibandronate (IBN) is a strong inhibitor of bone resorption. However, the effects of a vitamin D analogue, alfacalcidol (ALF), on IBN treatment for osteoporosis is unknown. Fifty-three...
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Published in | The Tohoku Journal of Experimental Medicine Vol. 241; no. 4; pp. 319 - 326 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
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Japan
Tohoku University Medical Press
01.04.2017
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ISSN | 0040-8727 1349-3329 1349-3329 |
DOI | 10.1620/tjem.241.319 |
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Abstract | Bisphosphonates (BPs) increase bone mineral density (BMD) through the inhibition of osteoclast activity. Among BPs, ibandronate (IBN) is a strong inhibitor of bone resorption. However, the effects of a vitamin D analogue, alfacalcidol (ALF), on IBN treatment for osteoporosis is unknown. Fifty-three treatment-naïve post-menopausal women with primary osteoporosis were recruited and divided into IBN-treatment group (IBN group) and IBN with ALF group (IBN/ALF group). IBN (1.0 mg) was intravenously injected once a month, with or without oral ALF (1.0 μg/day). Ultimately, 19 subjects in IBN group and 26 in IBN/ALF group were analyzed. Bone turnover markers were examined at 4, 6, 12, and 18 months, and BMD was measured at 6, 12, and 18 months. Compared with pre-treatment, bone turnover markers significantly decreased in both groups after 4 months. The levels of serum N-terminal propeptide of type-1 procollagen and tartrate-resistant acid phosphatase-5b, and urinary N-terminal telopeptide of type-I collagen were significantly lower in IBN/ALF group than those in IBN group at 12 months. Lumbar 1-4 (L)-BMD significantly increased from 6 months in IBN/ALF group and at 18 months in IBN group. L-BMD was significantly higher in IBN/ALF group (6.6% increase) than in IBN group (3.4%) at 18 months. Total hip (H)-BMD significantly increased from 6 months in IBN/ALF group and tended to improve in IBN group. H-BMD was significantly higher in IBN/ALF group (4.8%) than in IBN group (3.2%) at 18 months. In conclusion, treatment with ALF in combination with IBN improves BMD in post-menopausal women with osteoporosis. |
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AbstractList | Bisphosphonates (BPs) increase bone mineral density (BMD) through the inhibition of osteoclast activity. Among BPs, ibandronate (IBN) is a strong inhibitor of bone resorption. However, the effects of a vitamin D analogue, alfacalcidol (ALF), on IBN treatment for osteoporosis is unknown. Fifty-three treatment-naïve post-menopausal women with primary osteoporosis were recruited and divided into IBN-treatment group (IBN group) and IBN with ALF group (IBN/ALF group). IBN (1.0 mg) was intravenously injected once a month, with or without oral ALF (1.0 μg/day). Ultimately, 19 subjects in IBN group and 26 in IBN/ALF group were analyzed. Bone turnover markers were examined at 4, 6, 12, and 18 months, and BMD was measured at 6, 12, and 18 months. Compared with pre-treatment, bone turnover markers significantly decreased in both groups after 4 months. The levels of serum N-terminal propeptide of type-1 procollagen and tartrate-resistant acid phosphatase-5b, and urinary N-terminal telopeptide of type-I collagen were significantly lower in IBN/ALF group than those in IBN group at 12 months. Lumbar 1-4 (L)-BMD significantly increased from 6 months in IBN/ALF group and at 18 months in IBN group. L-BMD was significantly higher in IBN/ALF group (6.6% increase) than in IBN group (3.4%) at 18 months. Total hip (H)-BMD significantly increased from 6 months in IBN/ALF group and tended to improve in IBN group. H-BMD was significantly higher in IBN/ALF group (4.8%) than in IBN group (3.2%) at 18 months. In conclusion, treatment with ALF in combination with IBN improves BMD in post-menopausal women with osteoporosis. Bisphosphonates (BPs) increase bone mineral density (BMD) through the inhibition of osteoclast activity. Among BPs, ibandronate (IBN) is a strong inhibitor of bone resorption. However, the effects of a vitamin D analogue, alfacalcidol (ALF), on IBN treatment for osteoporosis is unknown. Fifty-three treatment-naïve post-menopausal women with primary osteoporosis were recruited and divided into IBN-treatment group (IBN group) and IBN with ALF group (IBN/ALF group). IBN (1.0 mg) was intravenously injected once a month, with or without oral ALF (1.0 μg/day). Ultimately, 19 subjects in IBN group and 26 in IBN/ALF group were analyzed. Bone turnover markers were examined at 4, 6, 12, and 18 months, and BMD was measured at 6, 12, and 18 months. Compared with pre-treatment, bone turnover markers significantly decreased in both groups after 4 months. The levels of serum N-terminal propeptide of type-1 procollagen and tartrate-resistant acid phosphatase-5b, and urinary N-terminal telopeptide of type-I collagen were significantly lower in IBN/ALF group than those in IBN group at 12 months. Lumbar 1-4 (L)-BMD significantly increased from 6 months in IBN/ALF group and at 18 months in IBN group. L-BMD was significantly higher in IBN/ALF group (6.6% increase) than in IBN group (3.4%) at 18 months. Total hip (H)-BMD significantly increased from 6 months in IBN/ALF group and tended to improve in IBN group. H-BMD was significantly higher in IBN/ALF group (4.8%) than in IBN group (3.2%) at 18 months. In conclusion, treatment with ALF in combination with IBN improves BMD in post-menopausal women with osteoporosis.Bisphosphonates (BPs) increase bone mineral density (BMD) through the inhibition of osteoclast activity. Among BPs, ibandronate (IBN) is a strong inhibitor of bone resorption. However, the effects of a vitamin D analogue, alfacalcidol (ALF), on IBN treatment for osteoporosis is unknown. Fifty-three treatment-naïve post-menopausal women with primary osteoporosis were recruited and divided into IBN-treatment group (IBN group) and IBN with ALF group (IBN/ALF group). IBN (1.0 mg) was intravenously injected once a month, with or without oral ALF (1.0 μg/day). Ultimately, 19 subjects in IBN group and 26 in IBN/ALF group were analyzed. Bone turnover markers were examined at 4, 6, 12, and 18 months, and BMD was measured at 6, 12, and 18 months. Compared with pre-treatment, bone turnover markers significantly decreased in both groups after 4 months. The levels of serum N-terminal propeptide of type-1 procollagen and tartrate-resistant acid phosphatase-5b, and urinary N-terminal telopeptide of type-I collagen were significantly lower in IBN/ALF group than those in IBN group at 12 months. Lumbar 1-4 (L)-BMD significantly increased from 6 months in IBN/ALF group and at 18 months in IBN group. L-BMD was significantly higher in IBN/ALF group (6.6% increase) than in IBN group (3.4%) at 18 months. Total hip (H)-BMD significantly increased from 6 months in IBN/ALF group and tended to improve in IBN group. H-BMD was significantly higher in IBN/ALF group (4.8%) than in IBN group (3.2%) at 18 months. In conclusion, treatment with ALF in combination with IBN improves BMD in post-menopausal women with osteoporosis. |
Author | Kamimura, Mikio Kato, Hiroyuki Suzuki, Takako Ikegami, Shota Nakamura, Yukio Uchiyama, Shigeharu |
Author_xml | – sequence: 1 fullname: Uchiyama, Shigeharu organization: Department of Orthopaedic Surgery, Shinshu University School of Medicine – sequence: 1 fullname: Suzuki, Takako organization: Department of Orthopaedic Surgery, Shinshu University School of Medicine – sequence: 1 fullname: Ikegami, Shota organization: Department of Orthopaedic Surgery, Shinshu University School of Medicine – sequence: 1 fullname: Kamimura, Mikio organization: Center of Osteoporosis and Spinal Disorders, Kamimura Orthopedic Clinic – sequence: 1 fullname: Kato, Hiroyuki organization: Department of Orthopaedic Surgery, Shinshu University School of Medicine – sequence: 1 fullname: Nakamura, Yukio organization: Department of Orthopedic Surgery, Showa-Inan General Hospital |
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CitedBy_id | crossref_primary_10_1016_j_afos_2019_06_001 crossref_primary_10_47360_1995_4484_2020_637_645 crossref_primary_10_1007_s11657_017_0371_y crossref_primary_10_1016_j_afos_2019_11_004 crossref_primary_10_1016_j_afos_2018_04_001 crossref_primary_10_3390_ijms25042125 |
Cites_doi | 10.1359/JBMR.040325 10.1007/s00776-003-0655-5 10.1007/s00198-011-1775-y 10.1093/ajcn/80.6.1689S 10.1007/s001980050214 10.2147/IJWH.S73944 10.1007/s00223-013-9734-6 10.1185/03007995.2011.580341 10.1016/j.clinthera.2009.02.012 10.1359/JBMR.050313 10.1038/boneres.2016.55 10.1002/jbmr.5650081308 10.1007/s00296-006-0288-z 10.1016/j.bone.2011.07.011 10.1186/s12902-015-0077-3 10.1007/s00296-012-2429-x 10.4172/2161-0509.1000188 10.1007/s11657-012-0109-9 10.3390/nu8060347 10.1620/tjem.237.339 10.1007/s00198-014-2817-z |
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(1999) A double-masked multicenter comparative study between alendronate and alfacalcidol in Japanese patients with osteoporosis. The Alendronate Phase III Osteoporosis Treatment Research Group. Osteoporos. Int., 10, 183-192. Nakamura, T., Nakano, T., Ito, M., Hagino, H., Hashimoto, J., Tobinai, M. & Mizunuma, H.; MOVER Study Group (2013) Clinical efficacy on fracture risk and safety of 0.5 mg or 1 mg/month intravenous ibandronate versus 2.5 mg/day oral risedronate in patients with primary osteoporosis. Calcif. Tissue Int., 93, 137-146. 11 22 12 23 13 14 15 16 17 18 19 1 2 3 4 5 6 7 8 9 20 10 21 |
References_xml | – reference: Chesnut, C.H. 3rd., Skag, A., Christiansen, C., Recker, R., Stakkestad, J.A., Hoiseth, A., Felsenberg, D., Huss, H., Gilbride, J., Schimmer, R.C. & Delmas, P.D.; Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE) (2004) Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J. Bone Miner. Res., 19, 1241-1249. – reference: Nakamura, T., Nakano, T., Ito, M., Hagino, H., Hashimoto, J., Tobinai, M. & Mizunuma, H.; MOVER Study Group (2013) Clinical efficacy on fracture risk and safety of 0.5 mg or 1 mg/month intravenous ibandronate versus 2.5 mg/day oral risedronate in patients with primary osteoporosis. Calcif. Tissue Int., 93, 137-146. – reference: Silverman, S. & Christiansen, C. (2012) Individualizing osteoporosis therapy. Osteoporos. Int., 23, 797-809. – reference: Ringe, J.D., Farahmand, P., Schacht, E. & Rozehnal, A. (2007) Superiority of a combined treatment of Alendronate and Alfacalcidol compared to the combination of Alendronate and plain vitamin d or Aalfacalcidol alone in established postmenopausal or male osteoporosis (AAC-Trial). Rheumatol. Int., 27, 425-434. – reference: Orimo, H., Nakamura, T., Fukunaga, M., Ohta, H., Hosoi, T., Uemura, Y., Kuroda, T., Miyakawa, N., Ohashi, Y. & Shiraki, M.; A-TOP (Adequate Treatment of Osteoporosis) research group (2011) Effects of alendronate plus alfacalcidol in osteoporosis patients with a high risk of fracture: the Japanese Osteoporosis Intervention Trial (JOINT) - 02. Curr. Med. Res. Opin., 27, 1273-1284. – reference: Nakamura, Y., Kamimura, M., Ikegami, S., Mukaiyama, K., Uchiyama, S., Kato, H. & Taguchi, A. (2015) Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study. BMC Endocr. Disord., 15, 81. – reference: DeLuca, H.F. (2004) Overview of general physiologic features and functions of vitamin D. Am. J. Clin. Nutr., 80 (6 Suppl), 1689S-1696S. – reference: Bouillon, R., Okamura, W.H. & Norman, A.W. (1995) Structure-function relationships in the vitamin D endocrine system. Endocr. Rev., 16, 200-257. – reference: Mukaiyama, K., Uchiyama, S., Nakamura, Y., Ikegami, S., Taguchi, A., Kamimura, M. & Kato, H. (2015) Eldecalcitol, in combination with bisphosphonate, is effective for treatment of Japanese osteoporotic patients. Tohoku J. Exp. Med., 237, 339-343. – reference: Paggiosi, M.A., Peel, N., McCloskey, E., Walsh, J.S. & Eastell, R. (2014) Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: the TRIO study. Osteoporos. Int., 25, 2729-2741. – reference: Shiraki, M., Kushida, K., Fukunaga, M., Kishimoto, H., Taga, M., Nakamura, T., Kaneda, K., Minaguchi, H., Inoue, T., Morii, H., Tomita, A., Yamamoto, K., Nagata, Y., Nakashima, M. & Orimo, H. (1999) A double-masked multicenter comparative study between alendronate and alfacalcidol in Japanese patients with osteoporosis. The Alendronate Phase III Osteoporosis Treatment Research Group. Osteoporos. Int., 10, 183-192. – reference: Miller, P.D., McClung, M.R., Macovei, L., Stakkestad, J.A., Luckey, M., Bonvoisin, B., Reginster, J.Y., Recker, R.R., Hughes, C., Lewiecki, E.M., Felsenberg, D., Delmas, P.D., Kendler, D.L., Bolognese, M.A., Mairon, N. & Cooper, C. (2005) Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J. Bone Miner. Res., 20, 1315-1322. – reference: Ste-Marie, L.G., Brown, J.P., Beary, J.F., Matzkin, E., Darbie, L.M., Burgio, D.E. & Racewicz, A.J. 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SubjectTerms | Absorptiometry, Photon Administration, Intravenous Administration, Oral Aged alfacalcidol Asian Continental Ancestry Group Bone Density - drug effects Bone Density Conservation Agents - therapeutic use bone mineral density bone turnover markers Diphosphonates - therapeutic use Drug Synergism Female Hip - diagnostic imaging Humans Hydroxycholecalciferols - adverse effects Hydroxycholecalciferols - therapeutic use ibandronate osteoporosis Osteoporosis - drug therapy Postmenopause Tartrate-Resistant Acid Phosphatase - blood |
Title | Alfacalcidol Increases the Therapeutic Efficacy of Ibandronate on Bone Mineral Density in Japanese Women with Primary Osteoporosis |
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