Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis

Journal of Clinical Endocrinology and Metabolism

Volumn 100, Issue 2, 2015, Pages 697-706

  Leder, Benjamin Z ^a   O'Dea, Louis St L ^b   Zanchetta, José R ^d   Kumar, Prasana ^c   Banks, Kathleen ^b   McKay, Kathleen ^b   Lyttle, C Richard ^b   Hattersley, Gary ^b  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b Radius Health Inc   (United States)

^c Centre for Diabetes and Endocrine Care   (India)

^d Instituto de Investigaciones Metabolicas   (Argentina)

Author keywords

[No Author keywords available]

Indexed keywords

ABALOPARATIDE; BIOLOGICAL MARKER; PARATHYROID HORMONE[1-34]; PLACEBO; BONE DENSITY CONSERVATION AGENT; PARATHYROID HORMONE RELATED PROTEIN;

ADULT; AGED; ARTICLE; BONE DENSITY; BONE TURNOVER; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMALE; FEMUR NECK; HIP; HUMAN; LUMBAR SPINE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OSTEOPOROSIS; POSTMENOPAUSE; PRIORITY JOURNAL; TREATMENT DURATION; CLINICAL TRIAL; DRUG EFFECTS; LUMBAR VERTEBRA; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; RADIOGRAPHY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; DOUBLE-BLIND METHOD; FEMALE; FEMUR NECK; HUMANS; LUMBAR VERTEBRAE; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; PARATHYROID HORMONE-RELATED PROTEIN; TERIPARATIDE; TREATMENT OUTCOME;

EID: 84922553490     PISSN: 0021972X     EISSN: 19457197     Source Type: Journal    
DOI: 10.1210/jc.2014-3718     Document Type: Article

References (32)

1. 2004. Bone health and osteoporosis: A report of the Surgeon General. In: United States Department of Health and Human Services PHS, ed. Office of the Surgeon General.
2. Papapoulos SE Use of bisphosphonates in the management of post-menopausal osteoporosis. Ann N Y Acad Sci. 2011; 1218: 15-32.
3. Cosman F. Parathyroid hormone treatment for osteoporosis. Curr Opin Endocrinol Diabetes Obes. 2008; 15: 495-501.
4. MacLean C, Newberry S, Maglione M, et al. Systematic review: Comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med. 2008; 148: 197-213.
5. Recker RR, Marin F, Ish-Shalom S, et al. Comparative effects of teriparatide and strontium ranelate on bone biopsies and biochemical markers of bone turnover in postmenopausal women with osteoporosis. J Bone Miner Res. 2009; 24: 1358-1368.
6. Dempster DW, Zhou H, Recker RR, et al. Skeletal histomorphometry in subjects on teriparatide or zoledronic acid therapy (SHOTZ) study: A randomized controlled trial. J Clin Endocrinol Metab. 2012; 97: 2799-2808.
7. Ma YL, Marin F, Stepan J, et al. Comparative effects of teriparatide and strontium ranelate in the periosteum of iliac crest biopsies in postmenopausal women with osteoporosis. Bone. 2011; 48: 972-978.
8. Leder BZ, Tsai JN, Uihlein AV, 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: 1694-1700.
9. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34)on fractures and bone mineral densityin postmenopausal women with osteoporosis. N Engl J Med. 2001; 344: 1434-1441.
10. Kronenberg HM PTHrP and skeletal development. Ann N Y Acad Sci. 2006; 1068: 1-13.
11. Pioszak AA, Parker NR, Gardella TJ, Xu HE. Structural basis for parathyroid hormone-related protein binding to the parathyroid hormone receptor and design of conformation-selective peptides. J Biol Chem. 2009; 284: 28382-28391.
12. Okazaki M, Ferrandon S, Vilardaga JP, Bouxsein ML, Potts JT, Jr, Gardella TJ. Prolonged signaling at the parathyroid hormone receptor by peptide ligands targeted to a specific receptor conformation. Proc Natl Acad Sci U S A. 2008; 105: 16525-16530.
13. Dean T, Vilardaga JP, Potts JT, Jr, Gardella TJ. Altered selectivity of parathyroid hormone (PTH) and PTH-related protein (PTHrP) for distinct conformations of the PTH/PTHrP receptor. Mol Endocrinol. 2008; 22: 156-166.
14. Horwitz MJ, Augustine M, Khan L, et al. A comparison of parathyroid hormone-related protein (1-36) and parathyroid hormone (1-34) on markers of bone turnover and bone density in postmenopausal women: The PrOP study. J Bone Miner Res. 2013; 28: 2266-2276.
15. Horwitz MJ, Tedesco MB, Garcia-Ocaña A, et al. Parathyroid hormone-related protein for the treatment of postmenopausal osteoporosis: Defining the maximal tolerable dose. J Clin Endocrinol Metab. 2010; 95: 1279-1287.
16. Horwitz MJ, Tedesco MB, Sereika SM, et al. Safety and tolerability of subcutaneous PTHrP(1-36) in healthy human volunteers: A dose escalation study. Osteoporos Int. 2006; 17: 225-230.
17. Obaidi M, Chavira RE, Reinbolt L, Offman E, McKay E, O'Dea LL. Pharmacokinetics and Pharmacokinetics and pharmacodynamic of subcutaneously (SC) administered doses of BA058, a bone mass density restoring agent in healthy postmenopausal women. AAPS. 2010 (abstract); W5385.
18. Doyle N, Varela A, Smith SY, Guldberg R, Hattersley G. Long Term effect of BA058, a Novel Human PTHrP Analog, Restores Bone Mass in the Aged Osteopenic Ovariectomized Cynomolgus Monkey. J Bone Miner Res. 2013; 28(Suppl 1)(abstract).
19. Hattersley G, Lesage E, Varela A, Mith SY. BA058, aNovel Human PTHrP Analog, Restores Bone Density and Increases Bone Strength At the Spine and Femur in Osteopenic Rats. Endocr Rev. 2013; 34(abstract).
20. Bonnick SL, Johnston CC, Jr, Kleerekoper M, et al. Importance of precision in bone density measurements. J Clin Densitom. 2001; 4: 105-110.
21. Bonnick S, Saag KG, Kiel DP, et al. Comparisonofweekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab. 2006; 91: 2631-2637.
22. Gallagher JC, Rosen CJ, Chen P, Misurski DA, Marcus R. Response rate of bone mineral density to teriparatide in postmenopausal women with osteoporosis. Bone. 2006; 39: 1268-1275.
23. Hochberg MC, Ross PD, Black D, et al. Larger increases in bone mineral density during alendronate therapy are associated with a lower risk of new vertebral fractures in women with postmenopausal osteoporosis. Fracture Intervention Trial Research Group. Arthritis Rheum. 1999; 42: 1246-1254.
24. Miller PD, McClung MR, Macovei L, et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res. 2005; 20: 1315-1322.
25. Sebba AI Significance of a decline in bone mineral density while receiving oral bisphosphonate treatment. Clin Ther. 2008; 30: 443-452.
26. Sebba AI, Bonnick SL, Kagan R, et al. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Curr Med Res Opin. 2004; 20: 2031-2041.
27. Hansen S, Hauge EM, Beck Jensen JE, Brixen K. Differing effects of PTH 1-34, PTH 1-84, and zoledronic acid on bone microarchitecture and estimated strength in postmenopausal women with osteoporosis: An 18-month open-labeled observational study using HR-pQCT. J Bone Miner Res. 2013; 28: 736-745.
28. Tsai J, Uihlein A, Burnett-Bowie SM, et al. Comparative effects of teriparatide, denosumab, and combination therapy on peripheral compartmental bone density, microarchitecture, and estimated strength: the DATA-HRpQCT Study. J Bone Miner Res. DOI: 10.1002/jbmr.2315. Online date July 17, 2014.
29. Nishiyama KK, Cohen A, Young P, et al. Teriparatide increases strength of the peripheral skeleton in premenopausal women with idiopathic osteoporosis: A pilot HR-pQCT study. J Clin Endocrinol Metab. 2014; 99: 2418-2425.
30. Ma YL, Zeng QQ, Chiang AY, et al. Effects of teriparatide on cortical histomorphometric variables in postmenopausal women with or without prior alendronate treatment. Bone. 2014; 59: 139-147.
31. Keaveny TM, McClung MR, Wan X, Kopperdahl DL, Mitlak BH, Krohn K. Femoral strength in osteoporotic women treated with teriparatide or alendronate. Bone. 2012; 50: 165-170.
32. Han SL, Wan SL. Effect of teriparatide on bone mineral density and fracture in postmenopausal osteoporosis: Meta-analysis of randomised controlled trials. Int J Clin Pract. 2012; 66: 199-209.