• Media type: E-Article
  • Title: Therapy of Hypoparathyroidism With rhPTH(1-84): A Prospective, 8-Year Investigation of Efficacy and Safety
  • Contributor: Tay, Yu-Kwang Donovan; Tabacco, Gaia; Cusano, Natalie E; Williams, John; Omeragic, Beatriz; Majeed, Rukshana; Gomez Almonte, Maximo; Bilezikian, John P; Rubin, Mishaela R
  • imprint: The Endocrine Society, 2019
  • Published in: The Journal of Clinical Endocrinology & Metabolism
  • Language: English
  • DOI: 10.1210/jc.2019-00893
  • ISSN: 0021-972X; 1945-7197
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Context</jats:title> <jats:p>Conventional treatment of hypoparathyroidism is associated with decreased renal function and increased bone mineral density (BMD).</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>To evaluate the effects of 8 years of recombinant human parathyroid hormone (1-84) [rhPTH(1-84)] therapy on key biochemical and densitometric indices.</jats:p> </jats:sec> <jats:sec> <jats:title>Design</jats:title> <jats:p>Prospective open-label trial.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting</jats:title> <jats:p>Tertiary medical center.</jats:p> </jats:sec> <jats:sec> <jats:title>Participants</jats:title> <jats:p>Twenty-four subjects with hypoparathyroidism.</jats:p> </jats:sec> <jats:sec> <jats:title>Intervention</jats:title> <jats:p>Treatment with rhPTH(1-84) for 8 years.</jats:p> </jats:sec> <jats:sec> <jats:title>Main Outcome Measures</jats:title> <jats:p>Supplemental calcium and vitamin D requirements, serum calcium and phosphorus levels, calcium-phosphate product, urinary calcium excretion, estimated glomerular filtration rate (eGFR) and BMD.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>PTH therapy was associated with progressive reduction in supplemental calcium (57%; P &lt; 0.01) and active vitamin D (76%; P &lt; 0.001) requirements over 8 years. Serum calcium concentration was stable; urinary calcium excretion declined 38% (P &lt; 0.01). eGFR remained stable and was related to baseline eGFR and serum calcium levels. Calcium-phosphate product was below the recommended limit; serum phosphorus remained within normal range. Lumbar spine and total hip BMD increased, peaking at 4 (mean ± SE, 4.6% ± 1.5%; P = 0.01) and 8 years (2.6% ± 1.1%; P = 0.02), whereas femoral neck BMD did not change and one-third radius BMD decreased (mean ± SE, −3.5% ± 1.1%; P = 0.001). BMD at all sites was higher throughout the 8 years than in the age- and sex-matched reference population. Hypercalcemia and hypocalcemia were uncommon.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>rhPTH(1-84) is a safe and effective treatment for hypoparathyroidism for 8 years. Long-term reductions in supplemental requirements and biochemical improvements with stable renal function are maintained.</jats:p> </jats:sec>
  • Access State: Open Access