PTH(1–34) for Surgical Hypoparathyroidism: A Prospective, Open-Label Investigation of Efficacy and Quality of Life

Context: Conventional therapy for hypoparathyroidism consists of calcium and calcitriol, but sometimes normal serum calcium cannot be maintained, and/or this approach might lead to nephrocalcinosis, nephrolithiasis, or renal insufficiency. Objective: The objective of the study was to investigate the effects of 6 months of PTH(1–34) treatment in adult subjects with postoperative hypoparathyroidism and to evaluate quality-of-life changes. Design: This was a 2-year prospective, open-label study. At baseline and after 6 months of PTH(1–34) treatment, calcium and vitamin D supplementation requirements, serum calcium, phosphate, creatinine, alkaline phosphatase, uric acid, and 24-hour urinary calcium excretion were evaluated. Quality of life was evaluated by the Rand 36-Item Short Form Health Survey covering eight domains of physical and mental health. Setting: This was an Italian multicentric study. Participants: Participants included 42 subjects with surgical hypoparathyroidism (90% females, age range 34–77 y). Intervention: The intervention included a twice-daily PTH(1–34) 20 μg sc injection. Results: The mean serum calcium levels significantly increased from baseline to 15 days (7.6 ± 0.6 vs 9.1 ± 0.9 mg/dL, P < .001) and remained stable until the end of the observational period, despite a significant reduction in calcium and vitamin D supplementation. Phosphate levels gradually decreased from baseline to the sixth month (P = .005 for the trend), whereas the alkaline phosphatase increased (P < .001). Data from the Rand 36-Item Short Form Health Survey showed a significant improvement in the mean scores of all eight domains (P < .001). Conclusion: This is the largest study that demonstrates the effectiveness of PTH(1–34) in the treatment of adult patients with postsurgical hypoparathyroidism, and it shows that PTH(1–34) may improve the mental and physical health in hypoparathyroid subjects.