Therapy of Hypoparathyroidism with PTH(1–84): A Prospective Four-Year Investigation of Efficacy and Safety

• Published in: The journal of clinical endocrinology and metabolism Vol. 98; no. 1; pp. 137 - 144
• Main Authors: Cusano, Natalie E., Rubin, Mishaela R., McMahon, Donald J., Zhang, Chiyuan, Ives, Rebecca, Tulley, Amanda, Sliney, James, Cremers, Serge C., Bilezikian, John P.
• Format: Journal Article
• Language: English
• Published: Bethesda, MD Oxford University Press 01.01.2013; Copyright by The Endocrine Society; Endocrine Society
• Subjects: Adult; Aged; Biological and medical sciences; Bone mineral density; Bone turnover; Calcium (blood); Calcium (urinary); Calcium - administration & dosage; Endocrine Care; Endocrinopathies; Feeding. Feeding behavior; Female; Follow-Up Studies; Fundamental and applied biological sciences. Psychology; Hormone Replacement Therapy - adverse effects; Humans; Hypercalcemia; Hypoparathyroidism; Hypoparathyroidism - drug therapy; Male; Medical sciences; Middle Aged; Non tumoral diseases. Target tissue resistance. Benign neoplasms; Parathyroid hormone; Parathyroid Hormone - administration & dosage; Parathyroid Hormone - adverse effects; Parathyroid Hormone - therapeutic use; Parathyroids. Parafollicular cells. Cholecalciferol. Phosphocalcic homeostasis (diseases); Phosphorus; Prospective Studies; Radius; Spine (lumbar); Time Factors; Treatment Outcome; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Vertebrates: endocrinology; Vitamin D; Vitamin D - administration & dosage; Vitamin D - analogs & derivatives; Endocrinopathy; Obesity; Nutrition; Toxicity; Nutrition disorder; Metabolic diseases; Prospective; Treatment; Parathyroid diseases; Hypoparathyroidism; Safety; Endocrinology; Nutritional status
• ISSN: 0021-972X; 1945-7197; 1945-7197
• DOI: 10.1210/jc.2012-2984

Context:PTH may be an effective treatment option for hypoparathyroidism, but long-term data are not available.Objective:We studied the effect of 4 yr of PTH(1–84) treatment in hypoparathyroidism.Design:Twenty-seven subjects were treated with PTH(1–84) for 4 yr, with prospective monitoring of calcium and vitamin D requirements, serum and urinary calcium, serum phosphorus, bone turnover markers, and bone mineral density (BMD).Results:Treatment with PTH(1–84) reduced supplemental calcium requirements by 37% (P = 0.006) and 1,25-dihydroxyvitamin D requirements by 45% (P = 0.008). Seven subjects (26%) were able to stop 1,25-dihydroxyvitamin D completely. Serum calcium concentration remained stable, and urinary calcium and phosphorus excretion fell. Lumbar spine BMD increased by 5.5 ± 9% at 4 yr (P < 0.0001). Femoral neck and total hip BMD remained stable. At 4 yr, distal radius BMD was not different from baseline. Bone turnover markers increased significantly, reaching a 3-fold peak from baseline values at 6–12 months (P < 0.05 for all), subsequently declining to steady-state levels at 30 months. Hypercalcemia was uncommon (11 episodes in eight subjects over 4 yr; 1.9% of all values), with most episodes occurring within the first 6 months and resolving with adjustment of supplemental calcium and vitamin D.Conclusions:PTH(1–84) treatment of hypoparathyroidism for up to 4 yr maintains the serum calcium concentration, while significantly reducing supplemental calcium and 1,25-dihydroxyvitamin D requirements. Lumbar spine BMD increases without significant changes at other sites. These data provide support for the safety and efficacy of PTH(1–84) therapy in hypoparathyroidism for up to 4 yr.