Recombinant Human Parathyroid Hormone Effect on Health-Related Quality of Life in Adults With Chronic Hypoparathyroidism

Abstract

Context: Reduced health-related quality of life (HRQoL) is common in patients with hypoparathyroidism on conventional therapy 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 the multinational, randomized, placebo-controlled REPLACE study. Patients: 122 adults with chronic hypoparathyroidism. Intervention(s): Following an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0-9.0 mg/dL; 2.0-2.2 mmol/L), patients were randomized to receive placebo (n=39) or rhPTH(1-84) (n=83) (starting dose 50 mug/day, could be titrated up to 100 mug/day); supplement doses were adjusted to maintain target serum calcium levels. Main Outcome Measure(s): Change from baseline (post-optimization, at randomization) to Week 24 in HRQoL as assessed by the SF-36v2 health survey. 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 of the 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. Conclusions: Treatment with rhPTH(1-84) may improve HRQoL in adults with hypoparathyroidism.