Safety and Efficacy of Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism Randomly Assigned to Receive Fixed 25-μg or 50-μg Daily Doses.

Abstract

PURPOSE:

The present study examined the efficacy and safety of a lower rhPTH(1-84) dose.

METHODS:

RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84). The primary end point was the percentage of patients at week 8 with supplement reductions in calcium to ≤500 mg/d and in calcitriol to ≤0.25 μg/d, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal. The secondary end point was the percentage of patients at week 8 with a ≥50% reduction in calcium and calcitriol doses, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal.

FINDINGS:

Forty-two patients were randomized (25-μg group, n = 19; 50-μg group, n = 23). At week 8, the primary end point was achieved by 4 (21%; 95% CI, 6%-46%) and 6 (26%; 95% CI, 10%-48%) of the patients receiving 25 and 50 μg/d of rhPTH(1-84), respectively. The secondary end point was achieved by 2 (11%; 95% CI, 1%-33%) and 6 (26%; 95% CI, 10%-48%) of the patients receiving 25 and 50 μg/d of rhPTH(1-84), respectively. Treatment-emergent adverse events were reported by 11 (58%) patients in the 25-μg group and 17 (74%) patients in the 50-μg group.

IMPLICATIONS:

Doses as low as 25 µg/d of rhPTH(1-84) are well tolerated and may be effective for a subset of patients. ClinicalTrials.gov identifier: NCT01268098.

• Authors: John P Bilezikian, Bart L Clarke, Michael Mannstadt, Jeffrey Rothman, Tamara Vokes, Hak-Myung Lee, Alan Krasner
• Journal: Clinical therapeutics (Clin Ther) Vol. 39 Issue 10 Pg. 2096-2102 (Oct 2017) ISSN: 1879-114X [Electronic] United States
• PMID: 28942334 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• PTH protein, human
• Parathyroid Hormone
• Recombinant Proteins
• Calcitriol
• Calcium

Topics

• Adult
• Calcitriol (administration & dosage)
• Calcium (administration & dosage, blood)
• Dietary Supplements
• Female
• Humans
• Hypoparathyroidism (blood, drug therapy)
• Male
• Middle Aged
• Parathyroid Hormone (administration & dosage, adverse effects, therapeutic use)
• Recombinant Proteins (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome