Parathyroid Hormone Replacement Therapy in Hypoparathyroidism: A Meta-Analysis

X.-x. Liu; X.-y. Zhu; G.-h. Mei

doi:10.1055/s-0042-106970

Hormone and Metabolic Research, Inhaltsverzeichnis

Horm Metab Res 2016; 48(06): 377-383
DOI: 10.1055/s-0042-106970

Endocrine Care

Parathyroid Hormone Replacement Therapy in Hypoparathyroidism: A Meta-Analysis

X.-x. Liu

¹Department of Endocrinology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China

,

X.-y. Zhu

²Department of Neurology, Shanghai First People’s Hospital, Shanghai Jiao Tong University, Shanghai, China

,

G.-h. Mei

³Department of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China

› Institutsangaben

Abstract

This study investigated the effect of human parathyroid hormone replacement therapy on specific disease-related outcomes in patients with hypoparathyroidism. Medline, Cochrane, EMBASE, and Google Scholar databases were searched until January 13, 2015 for randomized trials using the following search terms: hypoparathyroidism, parathyroid hormone/PTH, and hormone replacement therapy. Five randomized controlled trials (n=245) that investigated effect of either PTH (1–34) (3 trials) or PTH (1–84) (2 trials) on serum calcium, phosphate, 1, 25-dihydroxyvitamin D, 25-dihydroxyvitamin D levels, and urine level of calcium were included in the meta-analysis. Both PTH (1–34) and PTH (1–84) therapies were not associated with change in serum calcium level compared with calcitriol/placebo. The level of 24-h urine calcium excretion had a significant decrease in PTH (1–34)-treated group compared placebo/calcitriol (control) group (p≤0.012). PTH (1–34) did not change serum phosphate (p=0.053). PTH (1–84) did not change level of 24-h urine calcium excretion compared with control (p≥0.214) but it did decrease the levels of serum phosphorous (p=0.000). Both PTH-replacement therapies were not associated with change in serum 1,25-dihydroxyvitamin D level compared with control (p≥0.606), but were associated with a significant decrease in serum 25-dihydroxyvitamin D levels (p≤0.04). In conclusion, although the number of randomized trial is limited, our meta-analysis suggests that PTH (1–34) replacement therapy may maintain the serum calcium levels in the normal range by reducing the levels of urine calcium excretion, and both replacement therapies may maintain 1,25-dihydroxyvitamin D serum levels by reducing serum level of 25-dihydroxyvitamin D.

Key words

parathyroid hormone 1–34 - calcitriol - calcium - bone mineral density

Volltext

Referenzen

References
1 Kim ES, Keating GM. Recombinant Human Parathyroid Hormone (1–84): A Review in Hypoparathyroidism. Drugs 2015; 75: 1293-1303
2 Rosato L, Avenia N, Bernante P, De Palma M, Gulino G, Nasi PG, Pelizzo MR, Pezzullo L. Complications of thyroid surgery: analysis of a multicentric study on 14,934 patients operated on in Italy over 5 years. World J Surg 2004; 28: 271-276
3 Youngwirth L, Benavidez J, Sippel R, Chen H. Parathyroid hormone deficiency after total thyroidectomy: incidence and time. J Surg Res 2010; 163: 69-71
4 Bergenfelz A, Jansson S, Martensson H, Reihner E, Wallin G, Kristoffersson A, Lausen I. Scandinavian Quality Register for Thyroid and Parathyroid Surgery: audit of surgery for primary hyperparathyroidism. Langenbecks Arch Surg 2007; 392: 445-451
5 Bilezikian JP, Khan A, Potts Jr JT, Brandi ML, Clarke BL, Shoback D, Juppner H, D’Amour P, Fox J, Rejnmark L, Mosekilde L, Rubin MR, Dempster D, Gafni R, Collins MT, Sliney J, Sanders J. Hypoparathyroidism in the adult: epidemiology, diagnosis, pathophysiology, target-organ involvement, treatment, and challenges for future research. J Bone Miner Res 2011; 26: 2317-2337
6 Rejnmark L, Sikjaer T, Underbjerg L, Mosekilde L. PTH replacement therapy of hypoparathyroidism. Osteoporos Int 2015; 24: 1529-1536
7 Pollak MR, Brown EM, Estep HL, McLaine PN, Kifor O, Park J, Hebert SC, Seidman CE, Seidman JG. Autosomal dominant hypocalcaemia caused by a Ca(2+)-sensing receptor gene mutation. Nat Genet 1994; 8: 303-307
8 Baron J, Winer KK, Yanovski JA, Cunningham AW, Laue L, Zimmerman D, Cutler Jr GB. Mutations in the Ca(2+)-sensing receptor gene cause autosomal dominant and sporadic hypoparathyroidism. Hum Mol Genet 1996; 5: 601-606
9 Christensen SE, Nissen PH, Vestergaard P, Mosekilde L. Familial hypocalciuric hypercalcaemia: a review. Curr Opin Endocrinol Diabetes Obes 2011; 18: 359-370
10 Watanabe S, Fukumoto S, Chang H, Takeuchi Y, Hasegawa Y, Okazaki R, Chikatsu N, Fujita T. Association between activating mutations of calcium-sensing receptor and Bartter’s syndrome. Lancet 2002; 360: 692-694
11 Shoback D. Clinical practice. Hypoparathyroidism. N Engl J Med 2008; 359: 391-403
12 Horwitz MJ, Stewart AF. Hypoparathyroidism: is it time for replacement therapy?. J Clin Endocrinol Metab 2008; 93: 3307-3309
13 Mannstadt M, Clarke BL, Vokes T, Brandi ML, Ranganath L, Fraser WD, Lakatos P, Bajnok L, Garceau R, Mosekilde L, Lagast H, Shoback D, Bilezikian JP. Efficacy and safety of recombinant human parathyroid hormone (1–84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. Lancet Diabetes Endocrinol 2013; 1: 275-283
14 Sikjaer T, Rejnmark L, Rolighed L, Heickendorff L, Mosekilde L. Hypoparathyroid Study G . The effect of adding PTH(1–84) to conventional treatment of hypoparathyroidism: a randomized, placebo-controlled study. J Bone Miner Res 2011; 26: 2358-2370
15 Mittendorf EA, Merlino JI, McHenry CR. Post-parathyroidectomy hypocalcemia: incidence, risk factors, and management. Am Surg 2004; 70: 114-119
16 Winer KK, Sinaii N, Reynolds J, Peterson D, Dowdy K, Cutler Jr GB. Long-term treatment of 12 children with chronic hypoparathyroidism: a randomized trial comparing synthetic human parathyroid hormone 1–34 versus calcitriol and calcium. J Clin Endocrinol Metab 2010; 95: 2680-2688
17 Watanabe A, Yoneyama S, Nakajima M, Sato N, Takao-Kawabata R, Isogai Y, Sakurai-Tanikawa A, Higuchi K, Shimoi A, Yamatoya H, Yoshida K, Kohira T. Osteosarcoma in Sprague–Dawley rats after long-term treatment with teriparatide (human parathyroid hormone (1–34)). J Toxicol Sci 2012; 37: 617-629
18 Winer KK, Ko CW, Reynolds JC, Dowdy K, Keil M, Peterson D, Gerber LH, McGarvey C, Cutler Jr GB. Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1–34) versus calcitriol and calcium. J Clin Endocrinol Metab 2003; 88: 4214-4220
19 Higgins JPT. Cochrane Collaboration Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration 2011; Available from www.cochrane-handbook.org 2011
20 Sutton AJ, Duval SJ, Tweedie RL, Abrams KR, Jones DR. Empirical assessment of effect of publication bias on meta-analyses. BMJ 2000; 320: 1574-1577
21 Winer KK, Yanovski JA, Cutler Jr GB. Synthetic human parathyroid hormone 1–34 vs calcitriol and calcium in the treatment of hypoparathyroidism. JAMA 1996; 276: 631-636
22 Winer KK, Yanovski JA, Sarani B, Cutler Jr GB. A randomized, cross-over trial of once-daily versus twice-daily parathyroid hormone 1–34 in treatment of hypoparathyroidism. J Clin Endocrinol Metab 1998; 83: 3480-3486
23 Cusano NE, Rubin MR, Sliney Jr J, Bilezikian JP. Mini-review: new therapeutic options in hypoparathyroidism. Endocrine 2012; 41: 410-414
24 Vanhees I, Gunst J, Janssens T, Wauters A, Van Herck E, Van Cromphaut S, Van den Berghe G, Owen HC. Enhanced immunoreceptor tyrosine-based activation motif signaling is related to pathological bone resorption during critical illness. Horm Metab Res 2013; 45: 862-869
25 Rauchova H, Vokurkova M, Pavelka S, Behuliak M, Tribulova N, Soukup T. N-3 polyunsaturated fatty acids supplementation does not affect changes of lipid metabolism induced in rats by altered thyroid status. Horm Metab Res 2013; 45: 507-512
26 PTH 1–84 (Natpara^®) prescribing information NJ, USA
27 Tashjian Jr AH, Gagel RF. Teriparatide [human PTH(1–34)]: 2.5 years of experience on the use and safety of the drug for the treatment of osteoporosis. J Bone Miner Res 2006; 21: 354-365
28 Teriparatide (Forteo^®) prescribing information [cited 2014 September 4]. Available from http://pi.lilly.com/us/forteo-pi.pdf
29 Lehwald N, Cupisti K, Krausch M, Ahrazoglu M, Raffel A, Knoefel WT. Coincidence of primary hyperparathyroidism and nonmedullary thyroid carcinoma. Horm Metab Res 2013; 45: 660-663