Teriparatide (recombinant human parathyroid hormone 1-34) in postmenopausal women with osteoporosis
systematic review
Keywords:
Osteoporosis, Fractures, bone, Postmenopause, Teriparatide, ReviewAbstract
CONTEXT AND OBJECTIVE: Osteoporosis is defined as a disease characterized by low bone mass and deterioration of the bone tissue microarchitecture. Teriparatide stimulates the formation and action of osteoblasts, which are responsible for bone formation, thus promoting bone tissue increase. The aim was to assess the effectiveness and safety of teriparatide for treating postmenopausal osteoporosis. METHODS: A systematic review was conducted using the Cochrane Collaboration methodology. RESULTS: 1) Teriparatide 20 µg or 40 µg versus placebo: there was a bene� t from teriparatide, considering the following outcomes: reduction in the number of new vertebral and non-vertebral fractures, and increased whole-body, lumbar and femoral bone mineral density. 2) Teriparatide 40 µg versus alendronate 10 mg/day for 14 months: there was no statistical difference regarding the incidence of new vertebral or non-vertebral fractures, although in the group that received teriparatide there was greater bone mineral density increase in the whole body, lumbar column and femur. 3) Estrogen plus teriparatide 25 µg versus estrogen: there was a bene� t, considering the following outcomes: reduction in the number of new vertebral fractures, and increased wholebody, lumbar and femoral bone mineral density after three years. CONCLUSIONS: When teriparatide is intermittently administered in low doses, it reduces the incidence of vertebral fractures (67%) and nonvertebral fractures (38%) and increases bone mineral density in the lumbar column and femur. There is a need for studies with longer observation in order to allow conclusions regarding the safety and duration of the therapeutic effects.
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References
Consensus development conference: prophylaxis and treatment of osteoporosis. Br Med J (Clin Res Ed). 1987;295(6603):914-5.
Kanis JA, Melton LJ 3rd, Christiansen C, Johnston CC, Khaltaev N. The diagnosis of osteoporosis. J Bone Miner Res. 1994;9(8):1137-41.
Doherty DA, Sanders KM, Kotowicz MA, Prince RL. Lifetime and five-year age-specific risks of first and subsequent osteo- porotic fractures in postmenopausal women. Osteoporos Int. 2001;12(1):16-23.
Kanis JA. Diagnosis of osteoporosis and assessment of fracture risk. Lancet. 2002;359(9321):1929-36.
Cranney A, Simon LS, Tugwell P, Adachi R, Ottawa Methods Group. Osteoporosis. In: Evidence-based Rheumatology. London: BMJ Books; 2003. p.225-32. Available from: http:// www.blackwellpublishing.com/medicine/bmj/rheumatology/ pdfs/alen.pdf. Accessed in 2008 (Sep 23).
Follin SL, Hansen LB. Current approaches to the prevention and treatment of postmenopausal osteoporosis. Am J Health Syst Pharm. 2003;60(9):883-901; quiz 903-4.
Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001;285(3):320-3.
Tosteston AN, Gabriel SE, Grove MR, Moncur MM, Kneeland TS, Melton LJ 3rd. Impact of hip and vertebral fractures on qual- ity-adjusted life years. Osteoporos Int. 2001;12(12):1042-9.
Greendale GA, Barrett-Connor E, Ingles S, Haile R. Late physi- cal and functional effects of osteoporotic fracture in women: the Rancho Bernardo Study. J Am Geriatr Soc.1995;43(9): 955-61.
Melton LJ 3rd, Chrischilles EA, Cooper C, Lane AW, Riggs BL. Perspective. How many women have osteoporosis? J Bone Miner Res. 1992;7(9):1005-10.
Delmas PD. Treatment of postmenopausal osteoporosis.Lancet. 2002;359(9322):2018-26.
Brown JP, Josse RG; Scientific Advisory Council of the Osteoporosis Society of Canada. 2002 clinical practice guidelines for diagnosis and management of osteoporosis in Canada. CMAJ. 2002;167(10 Suppl):S1-34.
AACE Osteoporosis Task Force. American Association of Clini- cal Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003. Endocr Pract. 2003;9(6):544-64.
Whitfield JF, Morley P, Willick GE. The bone-building action of the parathyroid hormone: implications for the treatment of osteoporosis. Drugs Aging. 1999;15(2):117-29.
Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1-12.
Higgins J, Green S, editors. Cochrane handbook for systematic reviews of interventions 4.2.6. The Cochrane Collaboration; 2006. Available from: http://www.cochrane.org/resources/ handbook/Handbook4.2.6Sep2006.pdf. Accessed in 2008 (Sep 23).
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 parathyroid hormone (1-34). J Clin Endocrinol Metab. 2004;89(7):3332-6.
Adis International Ltd. ALX 111: ALX1-11, parathyroid hormone (1-84) - NPS Allelix, PREOS, PTH, recombinant human parathyroid hormone, rhPTH (1-84). Drugs R D. 2003;4(4):231-5.
Rehman Q, Lang TF, Arnaud CD, Modin GW, Lane NE. Daily treatment with parathyroid hormone is associated with an increase in vertebral cross-sectional area in postmenopausal women with glucocorticoid-induced osteoporosis. Osteoporos Int. 2003;14(1):77-81.
Lane NE, Sanchez S, Modin GW, Genant HK, Pierini E, Arnaud CD. Bone mass continues to increase at the hip after parathyroid hormone treatment is discontinued in glucocorticoid-induced osteoporosis: results of a randomized controlled clinical trial. J Bone Miner Res. 2000;15(5):944-51.
Lane NE, Sanchez S, Modin GW, Genant HK, Pierini E, Arnaud CD. Parathyroid hormone treatment can reverse corticosteroid- induced osteoporosis. Results of a randomized controlled clinical trial. J Clin Invest. 1998;102(8):1627-33.
Cosman F, Nieves J, Woelfert L, Gordon S, Shen V, Lindsay
R. Parathyroid responsivity in postmenopausal women with osteoporosis during treatment with parathyroid hormone. vJ Clin Endocrinol Metab. 1998;83(3):788-90.
Hodsman AB, Fraher LJ. Biochemical responses to sequential human parathyroid hormone (1-38) and calcitonin in osteo- porotic patients. Bone Miner. 1990;9(2):137-52.
Kurland ES, Cosman F, McMahon DJ, Rosen CJ, Lindsay R, Bilezikian JP. Parathyroid hormone as a therapy for idiopathic osteoporosis in men: effects on bone mineral density and bone markers. J Clin Endocrinol Metab. 2000;85(9):3069-76.
Kaufman JM, Orwoll E, Goemaere S, et al. Teriparatide ef- fects on vertebral fractures and bone mineral density in men with osteoporosis: treatment and discontinuation of therapy. Osteoporos Int. 2005;16(5):510-6.
Orwoll ES, Scheele WH, Paul S, et al. The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone den- sity in men with osteoporosis. J Bone Miner Res. 2003;18(1): 9-17.
Jiang Y, Zhao JJ, Mitlak BH, Wang O, Genant HK, Eriksen EF. Recombinant human parathyroid hormone (1-34) [teriparatide] improves both cortical and cancellous bone structure. J Bone Miner Res. 2003;18(11):1932-41.
Hodsman AB, Kisiel M, Adachi JD, Fraher LJ, Watson PH. Histomorphometric evidence for increased bone turnover without change in cortical thickness or porosity after 2 years of cyclical hPTH(1-34) therapy in women with severe osteoporosis. Bone. 2000;27(2):311-8.
Hodsman AB, Hanley DA, Ettinger MP, et al. Efficacy and safety of human parathyroid hormone-(1-84) in increasing bone mineral density in postmenopausal osteoporosis. J Clin Endocrinol Metab. 2003;88(11):5212-20.
Black DM, Greenspan SL, Ensrud KE, et al. The effects of parathyroid hormone and alendronate alone or in com- bination in postmenopausal osteoporosis. N Engl J Med. 2003;349(13):1207-15.
Hodsman AB, Fraher LJ, Watson PH, et al. A randomized controlled trial to compare the efficacy of cyclical parathyroid hormone versus cyclical parathyroid hormone and sequential calcitonin to improve bone mass in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 1997;82(2):620-8.
Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathy- roid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344(19):1434-41.
Marcus R, Wang O, Satterwhite J, Mitlak B. The skeletal response to teriparatide is largely independent of age, initial bone mineral density, and prevalent vertebral fractures in postmenopausal women with osteoporosis. J Bone Miner Res. 2003;18(1):18-23.
Body JJ, Gaich GA, Scheele WH, et al. A randomized double- blind trial to compare the efficacy of teriparatide [recombinant human parathyroid hormone (1-34)] with alendronate in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2002;87(10):4528-35.
Lindsay R, Nieves J, Formica C, et al. Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on estrogen with osteoporosis. Lancet. 1997;350(9077):550-5.
Finkelstein JS, Klibanski A, Schaefer EH, Hornstein MD, Schiff I, Neer RM. Parathyroid hormone for the prevention of bone loss induced by estrogen deficiency. N Engl J Med. 1994;331(24):1618-23.
