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Recombinant parathyroid hormone shows promise for hypoparathyroidism
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Researchers from the College of Physicians and Surgeons at Columbia University in New York determined that human recombinant parathyroid hormone maintained serum calcium concentrations and reduced supplemental calcium and vitamin D requirements in patients with hypoparathyroidism.
The human recombinant parathyroid hormone (PTH[1-84]; NPS Pharmaceuticals) was used for the study in patients with hypoparathyroidism. Dosing began at 100 mcg subcutaneously and was administered every other day based on previous research. Calcium and vitamin D supplementation was titrated to reach a dose of 1.5 g per day of calcium and 0.25 mcg per day of 1,25-dihydroxyvitamin D, researchers wrote.
Researchers treated 27 patients aged 25 to 68 years with PTH(1-84) for 4 years and prospectively monitored their calcium and vitamin D requirements, along with serum and urinary calcium, serum phosphorus, bone turnover markers and bone mineral density.
“This is the first study to report the extended use of any PTH therapy in a well-described cohort over 4 years, in hypoparathyroidism or any other metabolic bone disease,” researchers wrote.
According to data, the PTH(1-84) therapy reduced supplemental calcium requirements by 37% (P=.006) and 1,25-dihydroxyvitamin D requirements by 45% (P=.008). Of the patients enrolled, seven (26%) were capable of completely stopping 1,25-dihydroxyvitamin D. Additionally, serum calcium concentration was stable, and researchers noted a decrease in urinary calcium and phosphorus excretion.
Further data indicate lumbar spine BMD increased by 5.5% at 4 years (P<.0001), whereas femoral neck and total hip BMD remained stable. At 4 years, distal radius BMD did not differ from baseline measurements, but bone turnover markers significantly increased to a threefold peak from baseline values from 6 to 12 months (P<.05 for all). However, at 30 months, these values declined to steady-state levels.
Common adverse events included musculoskeletal, gastrointestinal and genitourinary problems. In eight patients, 11 episodes of mild hypercalcemia were reported during 4 years (1.9%), with most occurring within the first 6 months of treatment.
The researchers suggest further studies to investigate the long-term effects of PTH(1-84) and whether major comorbidities linked to hypoparathyroidism could be reduced or even reversed with this therapy, they wrote.
Disclosure: Bilezikian is a consultant for Amgen, Eli Lilly, GlaxoSmithKline, Merck, NPS Pharmaceuticals, Radius and Warner Chilcott, and and has received research support from Amgen and NPS Pharmaceuticals. Cremers is a consultant for Brains-Online, Immunodiagnostics, Roche Diagnostics and Thar Pharmaceuticals, and has received research support from Roche Diagnostics. Rubin receives research support from NPS Pharmaceuticals. All other researchers report no relevant financial disclosures.
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