PTH(1-84) is associated with improved quality of life in hypoparathyroidism through 5 years of therapy

Abstract

Context: In hypoparathyroidism, quality of life (QOL) is compromised as compared to normal subjects. We previously reported our results showing an association with recombinant human PTH(1-84) therapy in hypoparathyroidism and improvement in QOL measures for 1 year.

Objective: We tested the hypothesis that PTH(1-84) therapy in hypoparathyroidism through 5 years would be associated with continued improvement in QOL measures.

Design: Sixty-nine hypoparathyroid subjects received open-label PTH(1-84). Before and during therapy, subjects completed the RAND 36-Item Short Form (SF-36) Health Survey, a measure of health-related QOL covering eight domains of physical and mental health.

Results: At baseline, subjects scored significantly lower than the normative reference range in all 8 domains (T-scores -1.4 to -0.9; P < .001 for all). With PTH therapy, intention-to-treat analysis showed significant improvement in the overall score at 2 months that persisted through 5 years (386 ± 19 to 482 ± 25; P < .0001). The mental component summary score improved at 2 months and was sustained through 5 years (199 ± 11 to 246 ± 14; P = .001), as did all four individual mental health domains and T-scores (vitality, social functioning, role emotional, mental health). The physical component summary score improved at 2 months and was sustained through 5 years (187 ± 10 to 237 ± 13; P < .0001), as did 3 physical health domains and T-scores (physical functioning, role physical, general health).

Conclusions: PTH(1-84) therapy is not only associated with improvement in biochemical and skeletal indices, previously well-documented, but also in mental and physical health as determined by the SF-36 metric.

Figure 1.

RAND 36-item health survey domain T-scores at baseline and 5 years of PTH(1–84) therapy. Values are mean ± SE. ^#, P < .001 compared to normal population. *, P < .05 compared to baseline. ^†, P < .01 compared to baseline. ^‡, P < .001 compared to baseline.

Figure 2.

Proportions of subjects that continued PTH(1–84) therapy with RAND SF-36 T-scores in the normal, below normal, low, and very low range at baseline and months 12, 24, 36, 48, and 60 of PTH(1–84) therapy. Normal: T-score ≥ 0, below normal: −1 SD ≥ T-score < 0, low: −2 SD ≥ T-score < −1, very low: T-score < −2 SD.