Recombinant human parathyroid hormone effect on health-related quality of life in adults with chronic hypoparathyroidism

Tamara J. Vokes, Michael Mannstadt, Michael A. Levine, Bart L. Clarke, P. Lakatos, Kristina Chen, Rebecca Piccolo, Alan Krasner, Dolores M. Shoback, John P. Bilezikian

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Context: Reduced health-related quality of life (HRQoL) is common in patients with hypoparathyroidism treated conventionally with calcium and active Vitamin D supplements. Objective: To examine the effects of recombinant human parathyroid hormone [rhPTH(1-84)] on HRQoL as measured by the 36-Item Short-Form Health Survey (SF-36) during a multinational, randomized, placebo-controlled study. Patients: Adults (N = 122) with chronic hypoparathyroidism. Intervention(s): After an optimization period when calcium and/or active Vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 mg/d, could be titrated up to 100 mg/d); supplement doses were adjusted to maintain target serum calcium levels. Main Outcome Measure(s): Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36. Results: Overall, the between-group differences were not statistically significant. However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P<0.05), general health (P<0.05), and vitality (P <0.001) domains as compared with baseline values. In the placebo group, there were no significant changes for any domains. The magnitude of change between 0 and 24 weeks in SF-36 scores was negatively correlated with baseline scores, such that patients with lower HRQoL at baseline were more likely to experience improvement in response to treatment. Conclusion: Treatment with rhPTH(1-84) may improve HRQoL in adults with hypoparathyroidism.

Original languageEnglish
Pages (from-to)722-731
Number of pages10
JournalJournal of Clinical Endocrinology and Metabolism
Volume103
Issue number2
DOIs
Publication statusPublished - Feb 1 2018

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Hypoparathyroidism
Quality of Life
Health
Calcium
Placebos
Vitamin D
Random Allocation
Health Surveys
Serum
Outcome Assessment (Health Care)
human PTH protein
Pain
Therapeutics

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Recombinant human parathyroid hormone effect on health-related quality of life in adults with chronic hypoparathyroidism. / Vokes, Tamara J.; Mannstadt, Michael; Levine, Michael A.; Clarke, Bart L.; Lakatos, P.; Chen, Kristina; Piccolo, Rebecca; Krasner, Alan; Shoback, Dolores M.; Bilezikian, John P.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 103, No. 2, 01.02.2018, p. 722-731.

Research output: Contribution to journalArticle

Vokes, TJ, Mannstadt, M, Levine, MA, Clarke, BL, Lakatos, P, Chen, K, Piccolo, R, Krasner, A, Shoback, DM & Bilezikian, JP 2018, 'Recombinant human parathyroid hormone effect on health-related quality of life in adults with chronic hypoparathyroidism', Journal of Clinical Endocrinology and Metabolism, vol. 103, no. 2, pp. 722-731. https://doi.org/10.1210/jc.2017-01471
Vokes, Tamara J. ; Mannstadt, Michael ; Levine, Michael A. ; Clarke, Bart L. ; Lakatos, P. ; Chen, Kristina ; Piccolo, Rebecca ; Krasner, Alan ; Shoback, Dolores M. ; Bilezikian, John P. / Recombinant human parathyroid hormone effect on health-related quality of life in adults with chronic hypoparathyroidism. In: Journal of Clinical Endocrinology and Metabolism. 2018 ; Vol. 103, No. 2. pp. 722-731.
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abstract = "Context: Reduced health-related quality of life (HRQoL) is common in patients with hypoparathyroidism treated conventionally with calcium and active Vitamin D supplements. Objective: To examine the effects of recombinant human parathyroid hormone [rhPTH(1-84)] on HRQoL as measured by the 36-Item Short-Form Health Survey (SF-36) during a multinational, randomized, placebo-controlled study. Patients: Adults (N = 122) with chronic hypoparathyroidism. Intervention(s): After an optimization period when calcium and/or active Vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 mg/d, could be titrated up to 100 mg/d); supplement doses were adjusted to maintain target serum calcium levels. Main Outcome Measure(s): Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36. Results: Overall, the between-group differences were not statistically significant. However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P<0.05), general health (P<0.05), and vitality (P <0.001) domains as compared with baseline values. In the placebo group, there were no significant changes for any domains. The magnitude of change between 0 and 24 weeks in SF-36 scores was negatively correlated with baseline scores, such that patients with lower HRQoL at baseline were more likely to experience improvement in response to treatment. Conclusion: Treatment with rhPTH(1-84) may improve HRQoL in adults with hypoparathyroidism.",
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