Efficacy and safety of abaloparatide for the treatment of post-menopausal osteoporosis

References

• Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement. 2000;17:1–45.
   Google Scholar
• Amin S, Achenbach SJ, Atkinson EJ, et al. Trends in fracture incidence: a population-based study over 20 years. J Bone Miner Res. 2014;29:581–589.
   PubMed Web of Science ®Google Scholar
• Cummings SR, Melton LJ. Epidemiology and outcomes of osteoporotic fractures. Lancet. 2002;359:1761–1767.
   PubMed Web of Science ®Google Scholar
• Black DM, Rosen CJ. Postmenopausal osteoporosis. N Engl J Med. 2016;374:254–262.
   PubMed Web of Science ®Google Scholar
• Gennari L, Rotatori S, Bianciardi S, et al. Treatment needs and current options for postmenopausal osteoporosis. Expert Opin Pharmacother. 2016;17:1141–1152.
   PubMed Web of Science ®Google Scholar
• Gennari L, Merlotti D, Valleggi F, et al. Selective estrogen receptor modulators for postmenopausal osteoporosis: current state of development. Drugs Aging. 2007;24:361–379.
   PubMed Web of Science ®Google Scholar
• Khosla S, Bilezikian JP, Dempster DW, et al. Benefits and risks of bisphosphonate therapy for osteoporosis. J Clin Endocrinol Metab. 2012;97:2272–2282.
   PubMed Web of Science ®Google Scholar
• Kearns AE, Khosla S, Kostenuik PJ. Receptor activator of nuclear factor κB ligand and osteoprotegerin regulation of bone remodeling in health and disease. Endocr Rev. 2008;29:155–192.
   PubMed Web of Science ®Google Scholar
• Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344:1434–1441.
   PubMed Web of Science ®Google Scholar
• Rubin MR, Bilezikian JP. New anabolic therapies in osteoporosis. Endocrinol Metab Clin North Am. 2003;32:285–308.
   PubMed Web of Science ®Google Scholar
• Cosman F. Anabolic and antiresorptive therapy for osteoporosis: combination and sequential approaches. Curr Osteoporos Rep. 2014;12:385–395.
   PubMed Web of Science ®Google Scholar
• Andrews EB, Gilsenan AW, Midkiff K, et al. The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the last 7 years. J Bone Miner Res. 2012;27:2429–2437.
   PubMed Web of Science ®Google Scholar
• Black DM, Bilezikian JP, Ensrud KE, et al. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med. 2005;353:555–565.
   PubMed Web of Science ®Google Scholar
• Kim SC, Kim DH, Mogun H, et al. Impact of the US Food and Drug Administration’s safety-related announcements on the use of bisphosphonates after hip fracture. J Bone Miner Res. 2016;31:1535–1540.
   Web of Science ®Google Scholar
• Ferrari S. Future directions for new medical entities in osteoporosis. Best Pract Clin Endocrinol Metab. 2014;28:859–870.
   PubMed Web of Science ®Google Scholar
• Canalis E, Giustina A, Bilezikian JP. Mechanisms of anabolic therapies for osteoporosis. N Engl J Med. 2007;357:905–916.
   PubMed Web of Science ®Google Scholar
• Compston J, Bowring C, Cooper A, et al. Diagnosis and management of osteoporosis in postmenopausal women and older men in the UK: National Osteoporosis Guideline Group (NOGG) update 2013. Maturitas. 2013;75:392–396.
   PubMed Web of Science ®Google Scholar
• Papaioannou A, Morin S, Cheung AM, et al. 2010 Clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ. 2010;182:1864–1873.
   PubMed Web of Science ®Google Scholar
• Khosla S, Hofbauer LC. Osteoporosis treatment: recent developments and ongoing challenges. Lancet Diabetes Endocrinol. 2017;5:898–907.
   PubMed Web of Science ®Google Scholar
• Cosman F. Long-term treatment strategies for postmenopausal osteoporosis. Curr Opin Rheumatol. 2018;30:420–426.
   PubMed Web of Science ®Google Scholar
• Shirley M. Abaloparatide: first global approval. Drugs. 2017;77:1363–1368.
   PubMed Web of Science ®Google Scholar
• Okazaki M, Potts JT, Gardella TJ. Identification and optimization of residues in PTH and PTHrP that determine altered modes of binding to the PTH/PTHrP receptor. J Bone Miner Res. 2008;23:S103.
   PubMed Web of Science ®Google Scholar
• Dean T, Vilardaga JP, Potts JT Jr, et al. Altered selectivity of parathyroid hormone (PTH) and PTH-related protein (PTHrP) for distinct conformations of the PTH/PTHrP receptor. Mol Endocrinol. 2008;22:156e66.
   Web of Science ®Google Scholar
• Cosman F. Abaloparatide: a new anabolic therapy on the horizon. Bonekey Rep. 2015;4:661.
   PubMed Web of Science ®Google Scholar
• Hattersley G, Dean T, Corbin BA, et al. Binding selectivity of abaloparatide for PTH-type-1-receptor conformations and effects on downstream signaling. Endocrinology. 2016;157:141–149.
   PubMed Web of Science ®Google Scholar
• Lee K, Brown D, Urena P, et al. Localization of parathyroid hormone/parathyroid hormone-related peptide receptor mRNA in kidney. Am J Physiol. 1996;270:F186–F191.
   PubMed Web of Science ®Google Scholar
• Lee M, Partridge NC. Parathyroid hormone signaling in bone and kidney. Curr Opin Nephrol Hypertens. 2009;18:298–302.
   PubMed Web of Science ®Google Scholar
• McCudden CR, Hains MD, Kimple RJ, et al. G-protein signaling: back to the future. Cell Mol Life Sci. 2005;62:551–577.
   PubMed Web of Science ®Google Scholar
• Pierce KL, Premont RT, Lefkowitz RJ. Seven-transmembrane receptors. Nat Rev Mol Cell Biol. 2002;3:639–650.
   PubMed Web of Science ®Google Scholar
• Ferrandon S, Feinstein TN, Castro M, et al. Sustained cyclic AMP production by parathyroid hormone receptor endocytosis. Nat Chem Biol. 2009;5:734–742.
   PubMed Web of Science ®Google Scholar
• Ugiyama T, Oda H. Osteoporosis therapy: bone modeling during growth and aging. Front Endocrinol (Lausanne). 2017;8:46.
   PubMedGoogle Scholar
• Wu M, Deng L, Zhu G, et al. G protein and its signaling pathway in bone development and disease. Front Biosci (Landmark Ed). 2010;15:957–985.
   PubMed Web of Science ®Google Scholar
• Stewart A, Cain R, Burr D, et al. Six month daily administration of parathyroid hormone and parathyroid hormone related protein peptides to adult ovariectomized rats markedly enhances bone mass and biomechanical properties: a comparison of human parathyroid hormone 1-34, parathyroid hormone-related protein 1-36, and SDZ-parathyroid hormone 893. J Bone Miner Res. 2000;15:1517–1525.
   PubMed Web of Science ®Google Scholar
• Xu J, Rong H, Ji H, et al. Effects of different dosages of parathyroid hormone-related protein 1-34 on the bone metabolism of the ovariectomized rat model of osteoporosis. Calcif Tissue Int. 2013;93:276–287.
   PubMed Web of Science ®Google Scholar
• Varela A, Chouinard L, Lesage E, et al. One year of abaloparatide, a selective activator of the PTH1 receptor, increased bone formation and bone mass in osteopenic ovariectomized rats without increasing bone resorption. J Bone Miner Res. 2017;32:24–33.
   PubMed Web of Science ®Google Scholar
• Doyle N, Varela A, Haile S, et al. Abaloparatide, a novel PTH receptor agonist, increased bone mass and strength in ovariectomized cynomolgus monkeys by increasing bone formation without increasing bone resorption. Osteoporos Int. 2018;29:685–697.
   PubMed Web of Science ®Google Scholar
• Jolette J, Attalla B, Varela A, et al. Comparing the incidence of bone tumors in rats chronically exposed to the selective PTH type 1 receptor agonist abaloparatide or PTH(1-34). Regul Toxicol Pharmacol. 2017;86:356–365.
   PubMed Web of Science ®Google Scholar
• US FDA. TymlosTM (abaloparatide) injection, for subcutaneous use: US prescribing information. 2017. cited 2018 Nov 11. https://www.accessdata. fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf
   Google Scholar
• Leder BZ, O’Dea LS, Zanchetta JR, et al. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015;100:697–706.
   PubMed Web of Science ®Google Scholar
• Bilezikian JP, Hattersley G, Fitzpatrick LA, et al. Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial. Osteoporos Int. 2018;29:323–328.
   PubMed Web of Science ®Google Scholar
• Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016;316:722–733.
   PubMed Web of Science ®Google Scholar
• Miller PD, Hattersley G, Lau E, et al. Bone mineral density response rates are greater in patients treated with abaloparatide compared with those treated with placebo or teriparatide: results from the ACTIVE phase 3 trial. Bone. 2018;120:137–140.
   PubMed Web of Science ®Google Scholar
• Moreira CA, Fitzpatrick LA, Wang Y, et al. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: the ACTIVE phase 3 trial. Bone. 2017;97:314–319.
   PubMed Web of Science ®Google Scholar
• Cosman F, Hattersley G, Hu MY, et al. Effects of abaloparatide-SC on fractures and bone mineral density in subgroups of postmenopausal women with osteoporosis and varying baseline risk factors. J Bone Miner Res. 2017;32:17–23.
   PubMed Web of Science ®Google Scholar
• Cosman F, Miller PD, Williams GC, et al. Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: results of the ACTIVExtend trial. Mayo Clin Proc. 2017;92:200–210.
   PubMed Web of Science ®Google Scholar
• Bone HG, Cosman F, Miller PD, et al. ACTIVExtend: 24 months of alendronate after 18 months of abaloparatide or placebo for postmenopausal osteoporosis. J Clin Endocrinol Metab. 2018;103:2949–2957.
   PubMed Web of Science ®Google Scholar
• Saeh J, Pais D, Hamad E, et al. Clinical development of an optimized abaloparatide transdermal patch. J Bone Miner Res. 2016;31(Suppl. 1):LB–1162; [cited 2018 Nov 14]. Available from: http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=51d4e88b-f79d-47e2-a15b-134f0c57b52e
   Google Scholar
• EMA/504599/2018. [cited 2019 Feb 19]. https://www.ema.europa.eu/documents/smop-initial/questions-answers-refusal-marketing-authorisation-eladynos-abaloparatide_en.pdf
   Google Scholar
• Le QA, Hay JW, Becker R, et al. Cost-effectiveness analysis of sequential treatment of abaloparatide followed by alendronate versus teriparatide followed by alendronate in postmenopausal women with osteoporosis in the United States. Ann Pharmacother. 2018:1060028018798034. doi: 10.1177/1060028018798034. [Epub ahead of print]
   Web of Science ®Google Scholar
• Boyce EG, Mai Y, Pham C. Abaloparatide: review of a next-generation parathyroid hormone agonist. Ann Pharmacother. 2018;52:462–472.
   PubMed Web of Science ®Google Scholar
• Reginster JY, Hattersley G, Williams GC, et al. Abaloparatide is an effective treatment option for postmenopausal osteoporosis: review of the number needed to treat compared with teriparatide. Calcif Tissue Int. 2018;103:540–545.
   PubMed Web of Science ®Google Scholar