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

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 μg/d, could be titrated up to 100 μg/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.

Trial registration: ClinicalTrials.gov NCT00732615.

Copyright © 2017 Endocrine Society

Figures

Figure 1.
Figure 1.
Change from baseline in SF-36 PCS and MCS scores. The change in (A) PCS score and (B) MCS score from baseline to week 24 is plotted as a function of baseline score in patients who received rhPTH(1-84) or placebo (red squares and blue circles, respectively). The regression line for rhPTH(1-84)-treated patients (solid red line) had a slope that did not encompass zero, whereas the slope of the line for placebo-treated patients (broken blue line) did. For all domains, normal population has the mean of 50 and a standard deviation of 10. CI, confidence interval.
Figure 2.
Figure 2.
Change in SF-36 scores and albumin-corrected total serum calcium levels. A time-course plot of the change from baseline to weeks 4, 12, and 24 in patients from North American and Western European sites who received rhPTH(1-84) or placebo (black and gray symbols, respectively). *P < 0.001 for rhPTH(1-84) vs baseline; †P < 0.05 for rhPTH(1-84) vs baseline; ‡P < 0.001 for placebo vs baseline; §P < 0.05 for placebo vs baseline. RE, role-emotional; SE, standard error.

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