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Published in: Drugs in R&D 4/2016

Open Access 01-12-2016 | Original Research Article

Assessment of Distal Radius Bone Mineral Density in Osteoporosis Patients Receiving Denosumab, Including Those with Rheumatoid Arthritis and Those Receiving Oral Glucocorticoids

Author: Hiroaki Matsuno

Published in: Drugs in R&D | Issue 4/2016

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Abstract

Background and Objectives

Recently, the osteoporosis treatment has attracted attention, and several drugs have been developed. Among these, bisphosphonates (BPs), parathyroid hormone (PTH) and anti-receptor activator of nuclear factor kappa B ligand (RANKL) monoclonal (MAb) denosumab (DMAb) are the major osteoporosis agents. Several studies demonstrated that the effect of osteoporosis agents is evaluated by lumar or hip dual energy X-ray absorptiometry (DXA). However, private clinic commonly use the radial DXA. On the other hand, rheumatoid arthritis (RA) is sometimes associated with osteoporosis but there is no established treatment approach. In addition, glucocorticoids (GCs) are often used in the treatment of RA and sometimes induce osteoporosis. The present study assessed the effect of DMAb on osteoporosis in patients divided into RA and RA + GC patients by radial DXA.

Patients

The therapeutic effect of denosumab was assessed in female osteoporosis patients using radial dual-energy X-ray absorptiometry (radial DXA) in three groups: those with postmenopausal osteoporosis (PO group), PO with rheumatoid arthritis (RA group), and PO with RA receiving glucocorticoids (RA + GC group).

Methods

In total, 427 PO patients 60 years of age or older with a young adult mean value of <70 %, as determined by radial DXA, were treated with denosumab. The denosumab treatment group comprised a PO group (n = 205), RA group (n = 156), and RA + GC group (n = 66). The control group comprised a PO group (n = 44) and RA group (n = 33) who received oral bisphosphonate. Bone mineral density (BMD) was determined by using radial DXA. The bone turnover marker type I collagen cross-linked N-telopeptide (NTx) was also measured.

Results and Conclusions

Radial DXA revealed a significant increase in BMD in the denosumab treatment group but not in the bisphosphonate treatment group. The onset of an increase in BMD with denosumab was slower in the RA group than in those without RA. The effect of denosumab in preventing increased NTx levels was smaller in the RA and RA + GC groups than in the PO group. Adherence to denosumab treatment was statistically significantly greater than for bisphosphonate treatment.
Literature
1.
go back to reference Mandema JW, Zheng J, Libanati C, Perez Ruixo JJ. Time course of bone mineral density changes with denosumab compared with other drugs in postmenopausal osteoporosis: a dose-response-based meta-analysis. J Clin Endocrinol Metab. 2014;99(10):3746–55.CrossRefPubMed Mandema JW, Zheng J, Libanati C, Perez Ruixo JJ. Time course of bone mineral density changes with denosumab compared with other drugs in postmenopausal osteoporosis: a dose-response-based meta-analysis. J Clin Endocrinol Metab. 2014;99(10):3746–55.CrossRefPubMed
2.
go back to reference Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int. 2000;11(1):83–91.CrossRefPubMed Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int. 2000;11(1):83–91.CrossRefPubMed
3.
go back to reference Nakamura T, Matsumoto T, Sugimoto T, Hosoi T, Miki T, Gorai I, et al. Clinical Trials Express: fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT). J Clin Endocrinol Metab. 2014;99(7):2599–607.CrossRefPubMedPubMedCentral Nakamura T, Matsumoto T, Sugimoto T, Hosoi T, Miki T, Gorai I, et al. Clinical Trials Express: fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT). J Clin Endocrinol Metab. 2014;99(7):2599–607.CrossRefPubMedPubMedCentral
4.
go back to reference Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, et al. Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010;25(10):2256–65.CrossRefPubMed Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, et al. Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010;25(10):2256–65.CrossRefPubMed
5.
go back to reference Leder BZ, Tsai JN, Uihlein AV, Burnett-Bowie SA, Zhu Y, Foley K, et al. Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. J Clin Endocrinol Metab. 2014;99(5):1694–700.CrossRefPubMedPubMedCentral Leder BZ, Tsai JN, Uihlein AV, Burnett-Bowie SA, Zhu Y, Foley K, et al. Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. J Clin Endocrinol Metab. 2014;99(5):1694–700.CrossRefPubMedPubMedCentral
6.
go back to reference Zebaze RM, Ghasem-Zadeh A, Bohte A, Iuliano-Burns S, Mirams M, Price RI, et al. Intracortical remodelling and porosity in the distal radius and post-mortem femurs of women: a cross-sectional study. Lancet. 2010;375(9727):1729–36.CrossRefPubMed Zebaze RM, Ghasem-Zadeh A, Bohte A, Iuliano-Burns S, Mirams M, Price RI, et al. Intracortical remodelling and porosity in the distal radius and post-mortem femurs of women: a cross-sectional study. Lancet. 2010;375(9727):1729–36.CrossRefPubMed
7.
go back to reference Yamauchi H, Fukunaga M, Nishikawa A, Orimo H. Changes in distribution of bone densitometry equipment from 1996 to 2006 in Japan. J Bone Miner Metab. 2010;28(1):60–7.CrossRefPubMed Yamauchi H, Fukunaga M, Nishikawa A, Orimo H. Changes in distribution of bone densitometry equipment from 1996 to 2006 in Japan. J Bone Miner Metab. 2010;28(1):60–7.CrossRefPubMed
8.
go back to reference Arnett FC, Edworthy SM, Bloch DA, McShane DJ. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315–24.CrossRefPubMed Arnett FC, Edworthy SM, Bloch DA, McShane DJ. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315–24.CrossRefPubMed
9.
go back to reference Matsuno H, Okada M, Sakai Y, Abe C, Katayama K, Sagawa A, et al. The usefulness of a new triple combination treatment utilizing methotrexate, salazosulfapyridine, and bucillamine in rheumatoid arthritis. Mod Rheumatol. 2016;26(1):51–6.CrossRefPubMed Matsuno H, Okada M, Sakai Y, Abe C, Katayama K, Sagawa A, et al. The usefulness of a new triple combination treatment utilizing methotrexate, salazosulfapyridine, and bucillamine in rheumatoid arthritis. Mod Rheumatol. 2016;26(1):51–6.CrossRefPubMed
10.
go back to reference Albaum JM, Youn S, Levesque LE, Gershon AS, Cadarette SM. Osteoporosis management among chronic glucocorticoid users: a systematic review. J Popul Ther Clin Pharmacol. 2014;21(3):e486–504.PubMed Albaum JM, Youn S, Levesque LE, Gershon AS, Cadarette SM. Osteoporosis management among chronic glucocorticoid users: a systematic review. J Popul Ther Clin Pharmacol. 2014;21(3):e486–504.PubMed
11.
go back to reference Dore RK, Cohen SB, Lane NE, Palmer W, Shergy W, Zhou L, Denosumab RA Study Group, et al. Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates. Ann Rheum Dis. 2010;69(5):872–5.CrossRefPubMed Dore RK, Cohen SB, Lane NE, Palmer W, Shergy W, Zhou L, Denosumab RA Study Group, et al. Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates. Ann Rheum Dis. 2010;69(5):872–5.CrossRefPubMed
12.
go back to reference Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, et al. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014;59:173–9.CrossRefPubMed Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, et al. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014;59:173–9.CrossRefPubMed
13.
go back to reference Cotté FE, Fardellone P, Mercier F, Gaudin AF, Roux C. Adherence to monthly and weekly oral bisphosphonates in women with osteoporosis. Osteoporos Int. 2010;21(1):145–55.CrossRefPubMed Cotté FE, Fardellone P, Mercier F, Gaudin AF, Roux C. Adherence to monthly and weekly oral bisphosphonates in women with osteoporosis. Osteoporos Int. 2010;21(1):145–55.CrossRefPubMed
14.
go back to reference Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov. 2010;9(10):767–74.CrossRefPubMed Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov. 2010;9(10):767–74.CrossRefPubMed
15.
go back to reference Lems WF, Lodder MC, Lips P, Bijlsma JW, Geusens P, Schrameijer N, et al. Positive effect of alendronate on bone mineral density and markers of bone turnover in patients with rheumatoid arthritis on chronic treatment with low-dose prednisone: a randomized, double-blind, placebo-controlled trial. Osteoporos Int. 2006;17(5):716–23.CrossRefPubMed Lems WF, Lodder MC, Lips P, Bijlsma JW, Geusens P, Schrameijer N, et al. Positive effect of alendronate on bone mineral density and markers of bone turnover in patients with rheumatoid arthritis on chronic treatment with low-dose prednisone: a randomized, double-blind, placebo-controlled trial. Osteoporos Int. 2006;17(5):716–23.CrossRefPubMed
16.
go back to reference Jensen TW, Hansen MS, Hørslev-Petersen K, Hyldstrup L, Abrahamsen B, Langdahl B, Cimestra Study Group, et al. Periarticular and generalised bone loss in patients with early rheumatoid arthritis: influence of alendronate and intra-articular glucocorticoid treatment. Post hoc analyses from the CIMESTRA trial. Ann Rheum Dis. 2014;73(6):1123–9.CrossRefPubMed Jensen TW, Hansen MS, Hørslev-Petersen K, Hyldstrup L, Abrahamsen B, Langdahl B, Cimestra Study Group, et al. Periarticular and generalised bone loss in patients with early rheumatoid arthritis: influence of alendronate and intra-articular glucocorticoid treatment. Post hoc analyses from the CIMESTRA trial. Ann Rheum Dis. 2014;73(6):1123–9.CrossRefPubMed
17.
go back to reference Takeuchi T, Tanaka Y, Ishiguro N, Yamanaka H, Yoneda T, Ohira T, et al. Effect of denosumab on Japanese patients with rheumatoid arthritis: a dose-response study of AMG 162 (Denosumab) in patients with RheumatoId arthritis on methotrexate to Validate inhibitory effect on bone Erosion (DRIVE)-a 12-month, multicentre, randomised, double-blind, placebo-controlled, phase II clinical trial. Ann Rheum Dis. 2016;75(6):983–90.CrossRefPubMed Takeuchi T, Tanaka Y, Ishiguro N, Yamanaka H, Yoneda T, Ohira T, et al. Effect of denosumab on Japanese patients with rheumatoid arthritis: a dose-response study of AMG 162 (Denosumab) in patients with RheumatoId arthritis on methotrexate to Validate inhibitory effect on bone Erosion (DRIVE)-a 12-month, multicentre, randomised, double-blind, placebo-controlled, phase II clinical trial. Ann Rheum Dis. 2016;75(6):983–90.CrossRefPubMed
18.
go back to reference Grossman JM, Gordon R, Ranganath VK, Deal C, Caplan L, Chen W, et al. American College of Rheumatology 2010 recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Care Res (Hoboken). 2010;2(11):1515–26.CrossRef Grossman JM, Gordon R, Ranganath VK, Deal C, Caplan L, Chen W, et al. American College of Rheumatology 2010 recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Care Res (Hoboken). 2010;2(11):1515–26.CrossRef
19.
go back to reference Di Fede O, Bedogni A, Giancola F, Saia G, Bettini G, Toia F, et al. BRONJ in patients with rheumatoid arthritis: a multicenter case series. Oral Dis. 2016;22(6):543–8.CrossRefPubMed Di Fede O, Bedogni A, Giancola F, Saia G, Bettini G, Toia F, et al. BRONJ in patients with rheumatoid arthritis: a multicenter case series. Oral Dis. 2016;22(6):543–8.CrossRefPubMed
Metadata
Title
Assessment of Distal Radius Bone Mineral Density in Osteoporosis Patients Receiving Denosumab, Including Those with Rheumatoid Arthritis and Those Receiving Oral Glucocorticoids
Author
Hiroaki Matsuno
Publication date
01-12-2016
Publisher
Springer International Publishing
Published in
Drugs in R&D / Issue 4/2016
Print ISSN: 1174-5886
Electronic ISSN: 1179-6901
DOI
https://doi.org/10.1007/s40268-016-0146-8

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