Update on the efficacy, safety, and adherence to treatment of full length parathyroid hormone, Pth (1-84), in the treatment of postmenopausal osteoporosis

International Journal of Women's Health

Volumn 1, Issue 1, 2009, Pages 193-203

  Pietrogrande, Luca ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

Full length parathyroid hormone; Osteoporosis treatment; PTH (1 84)

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; CALCIUM CARBONATE; ESTROGEN; PARATHYROID HORMONE; PARATHYROID HORMONE[1-34]; RECOMBINANT PARATHYROID HORMONE; RISEDRONIC ACID; VITAMIN D;

BACKACHE; BONE DENSITOMETRY; BONE DENSITY; BONE TURNOVER; CALCIUM BLOOD LEVEL; CALCIUM URINE LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DIZZINESS; DOSE RESPONSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; FATIGUE; FEMUR FRACTURE; HEADACHE; HUMAN; HYPERCALCEMIA; HYPERCALCIURIA; HYPERURICEMIA; INJECTION SITE REACTION; LIMB PAIN; MELANOMA; NAUSEA; NONHUMAN; OSTEOPOROSIS; OSTEOSARCOMA; PATIENT COMPLIANCE; POSTMENOPAUSE OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL; REVIEW; SIDE EFFECT; UNSPECIFIED SIDE EFFECT; VERTEBRA FRACTURE; VITAMIN SUPPLEMENTATION; VOMITING;

EID: 77953438185     PISSN: None     EISSN: 11791411     Source Type: Journal    
DOI: None     Document Type: Review

References (51)

1. Silverberg SJ, Shane E, de la Cruz L, et al. Skeletal disease in primary hyperparathyroidism. J Bone Miner Res. 1989;4:283-291.
2. Dempster DW, Parisien M, Silverberg SJ, et al. On the mechanism of cancellous bone preservation in postmenopausal women with mild primary hyperparathyroidism. J Clin Endocrinol Metab. 1999;84:1562-1566.
3. Bilezikian JP, Silverberg SJ, Shane E, et al. Characterization and evaluation of asymptomatic primary hyperparathyroidism. J Bone Miner Res. 1991;6 Suppl 2:S85-S89; discussion S121-S124.
4. Hodsman AB, Hanley DA, Ettinger MP, et al. Efficacy and safety of human PTH-(1-84) in increasing bone mineral density in postmenopausal osteoporosis. J Clin Endocrinol Metab. 2003;88:5212-5220.
5. Dempster DW, Cosman F, Parisien M, et al. Anabolic actions of PTH on bone. Endocr Rev. 1993;14:690-709.
6. Tam CS, Heersche JN, Murray TM, Parsons JA. PTH stimulates the bone apposition rate independently of its resorptive action: differential effects of intermittent and continuous administration. Endocrinology. 1982;110:506-512.
7. Calvo MS, Eastell R, Offord KP, et al. Circadian variation in ionized calcium and intact PTH: evidence for sex differences in calcium homeostasis. J Clin Endocrinol Metab. 1991;72:69-76.
8. Hock JM, Gera I. Effects of continuous and intermittent administration and inhibition of resorption on the anabolic response of bone to PTH. J Bone Miner Res. 1992;7:65-72.
9. Potts JT. PTH: past and present. J Endocrinol. 2005;187:311-325.
10. Stilgren LS, Rettmer E, Eriksen EF, Hegedüs L, Beck-Nielsen H, Abrahamsen B. Skeletal changes in osteoprotegerin and receptor activator of nuclear factor-kappaB ligand mRNA levels in primary hyperparathyroidism: effect of parathyroidectomy and association with bone metabolism. Bone. 2004;35:256-265.
11. Ma YL, Cain RL, Halladay DL, et al. Catabolic effects of continuous human PTH (1-38) in vivo is associated with sustained stimulation of RANKL and inhibition of osteoprotegerin and gene-associated bone formation. Endocrinology. 2001;142:4047-4054.
12. Onyia JE, Miles RR, Yang X, et al. In vivo demonstration that human PTH 1-38 inhibits the expression of osteoprotegerin in bone with the kinetics of an immediate early gene. J Bone Miner Res. 2000;15:863-871.
13. Locklin RM, Khosla S, Riggs BL. Mechanisms of biphasic anabolic and catabolic effects of PTH (PTH) on bone cells. Bone. 2001;28(Suppl):S80.
14. Jilka RL, Weinstein RS, Bellido T, Roberson P, Parf itt AM, Manolagas SC. Increased bone formation by prevention of osteoblast apoptosis with PTH. J Clin Invest. 1999;104:439-446.
15. Buxton EC, Yao W, Lane NE. Changes in serum receptor activator of nuclear factor-kappaB ligand, osteoprotegerin, and interleukin-6 levels in patients with glucocorticoid-induced osteoporosis treated with human PTH (1-34). J Clin Endocrinol Metab. 2004;89:3332-3336.
16. Adami S. Full length PTH, PTH (1-84), for the treatment of severe osteoporosis in postmenopausal women. Curr Med Res Opin. 2008;24:3259-3274.
17. European Medical Agency - Product Information 27/11/2007 Preotact-H-C-659-N-04. URL: http://www.emea.europa.eu/humandocs/PDFs/EPAR/ preotact/H-659-PI-en.pdf.
18. Greenspan SL, Bone HG, Ettinger MP, et al. Effect of recombinant human PTH (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med. 2007;146:326-339.
19. Roux C, Clausen J. Sustained effect of PTH (1-84) on the risk of vertebral fractures 12 months after cessation of therapy. Calcified Tissue Int. 2007;80(Suppl 1):S146.
20. Black DM, Greenspan SL, Ensrud KE, et al. The effects of PTH and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003;349:1207-1215.
21. Black DM, Bilezikian JP, Ensrud KE, et al. One year of alendronate after one year of PTH (1-84) for osteoporosis. N Engl J Med. 2005;353:555-565.
22. Fogelman I, Fordham JN, Fraser WD, et al. PTH(1-84) Treatment of Postmenopausal Women with Low Bone Mass Receiving Hormone Replacement Therapy. Calcified Tissue Int. 2008;83:85-92.
23. Jodar-Gimeno E, Leib ES, Zanchetta JR, Mautalen CA, Greisen H. Continued increase in hip BMD after 36 Months of PTH(1-84) treatment in Postmenopausal women. Calcified Tissue Int. 2008;82(Suppl 1):S231.
24. Hosking D, Brandi M, Díaz-Curiel M, Felsenberg D, Hyldstrup LH. One year of treatment with PTH(1-84) and the change in lumbar spine BMD in postmenopausal women with primary osteoporosis after pretreatment with a bisphosphonate. Bone. 2009;44(Suppl 2):S428.
25. Minisola S, Bone HG, Zanchetta JR, et al. Influence of lumbar spine BMD at baseline on the incidence of new vertebral fractures after 18 months treatment with PTH(1-84). Results from the top study. Calcified Tissue Int. 2008;82(Suppl 1):S238.
26. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of PTH (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344:1434-1441.
27. Roux C, Illera-martìn O, Clausen J. Efficacy of PTH (1-84) on vertebral and non-vertebral fractures in postmenopausal women with a high risk of vertebral fractures. Calcified Tissue Int. 2007;80(Suppl 1):S48.
28. Moen MD, Scott LJ. Recombinant full-length PTH (1-84). Drugs. 2006;66(18):2371-2381.
29. Black D, Bilezikian J, Greenspan S, et al. Gains in lumbar spine BMD in highly compliant patients treated with PTH (1-84). Bone. 2009;44(Suppl 2):S428-S429.
30. Khoo BC, Beck TJ, Qiao QH, et al. In vivo short-term precision of hip structure analysis variables in comparison with bone mineral density using paired dual-energy X-ray absorptiometry scans from multicenter clinical trials. Bone. 2005;37:112-121.
31. van Londen GJ, Palermo L, Beck TJ, et al. Hip structural analysis and volumetric qct in postmenopausal women from the PaTH study: monoor combination therapy with alendronate and PTH. J Bone Miner Res. 2008; ASBMR Annual Meeting Abstracts: M306.
32. Keaveny TM, Hoffmann PF, Singh M, et al. Femoral bone strength and its relation to cortical and trabecular changes after treatment with PTH, Alendronate, and their combination as assessed by Finite Element Analysis of Quantitative CT Scans. J Bone Miner Res. 2008;23:1974-1982.
33. Bilezikian JP. Combination anabolic and antiresorptive therapy for osteoporosis: opening the anabolic window. Curr Osteoporos Rep. 2008;6:24-30.
34. Miller PD. Safety of PTH for the treatment of osteoporosis. Curr Osteoporos Rep. 2008;6:12-16.
35. Vahle JL, Sato M, Long GG, et al. Skeletal changes in rats given daily subcutaneous injections of recombinant human PTH (1-34) for 2 years and relevance to human safety. Toxicol Pathol. 2002;30:312-321.
36. Vahle JL, Long GG, Ma YL, Sato M. Bone neoplasms in F344 rats given teriparatide [rhPTH (1-34)] are dependent on duration of treatment and dose. Toxicol Pathol. 2004;32:426-438.
37. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of PTH (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344:1434-1441.
38. Wilker CE, Jolette J, Smith SY, et al. No observable carcinogenic effect dose level identified in Fischer 344 rats following daily treatment with PTH (1-84) for 2 years: role of the c-terminal PTH receptor? J Bone Miner Res. 2004;19(Suppl 1):S98.
39. Harper K, Krege JH, Marcus R, Mitlak BH. Osteosarcoma and teriparatide? J Bone Miner Res. 2007;22:334.
40. Damron TA, Ward WG, Stewart A. Osteosarcoma, chondrosarcoma, and Ewing's sarcoma: National Cancer Data Base Report. Clin Orthop Relat Res. 2007;459:40-47.
41. Recker RR, Zanchetta CA, Mautalen CA, et al. Safety indices from iliac crest biopsies from postmenopausal osteoporotic women after 36 months of treatment with PTH(1-84). Bone. 2009;44(Suppl 2):S431-S432.
42. Forslund T, Koski AM, Koistinen A, Sikiö A. Malignant myeloma in a patient after treatment for osteoporosis with teriparatide; a rare coincidence. Clinical Medicine: Case Reports. 2008;1:119-122.
43. Vestergaard P, Jorgensen NR, Mosekilde L, Schwarz P. Effects of PTH alone or in combination with antiresorptive therapy on bone mineral density and fracture risk - a meta-analysis. Osteoporos Int. 2007;18:45-57.
44. Verhaar HJJ, Lems WF. PTH-analogs: comparable or different? Arch Gerontol Geriatr. 2009;49(2):e130-e132.
45. Antoniucci DM, Sellmeyer DE, Bilezikian JP, et al. Elevations in Serum and Urinary Calcium with PTH (1-84) with and without Alendronate for Osteoporosis. J Clin Endocrinol Metab. 2007;92(3):942-947.
46. Bevilacqua M, Dominguez LJ, Chebat E, et al. Treatment with daily subcutaneous teriparatide (1-34) compared with daily subcutaneous PTH (1-84) in women with severe postmenopausal osteoporosis: a randomized, head-to-head study. Osteoporos Int. 2009;20(Suppl 1):S173.
47. Black DM, Bouxsein ML, Palermo L, et al. Randomized trial of once-weekly PTH (1-84) on bone mineral density and remodeling. J Clin Endocrinol Metab. 2008;93:2166-2172.
48. Asmussen M, Benhamou CL, Törring O, Minisola S, Hyldstrup LH. Preferences from postmenopausal osteoporosis patients for administration of PTH treatment. Calcif Tissue Int. 2008;82(S1):P400.
49. Hosking D, Alonso CG, Brandi ML. Management of osteoporosis with PTH: treatment and prescription patterns in Europe. Curr Med Res Opin. 2009;25(1):263-270.
50. Perez-Edo L, Zanchetta JR, Mautalen CA, Bolognese MA, Greisen H. Safety of PTH (1-84) after 24 months therapy and a 12 months follow-up period. Calcif Tissue Int. 2008;82(Suppl 1):S241-S242.
51. Díaz-Curiel M, Hosking D, Brandi M, Hyldstrup LH, Felsenberg D. Serum calcium levels in postmenopausal women with osteoporosis after 1, 6 and 12 months of PTH (1-84) treatment - the latest results from the PEAK trial. Bone. 2009;44(Suppl 2):S435-S436.