Does Parathyroid hormone work?
Yes, in large controlled trials: a 134-adult trial.
The approval rests on REPLACE, a randomized, double-blind, placebo-controlled phase 3 trial in 134 adults with hypoparathyroidism, which met its primary endpoint of reducing conventional therapy while holding calcium in range. The grade applies to that use. The drug's practical availability, not its evidence, is what has collapsed. 1
REPLACE enrolled 134 adults with hypoparathyroidism. They were randomized to PTH(1-84) or placebo for 24 weeks. Active vitamin D and calcium were tapered as the study drug was adjusted. The primary endpoint was a drop of 50 percent or more in both oral calcium and active vitamin D. Blood calcium had to stay in the target range. About 53 percent of patients on PTH met it. On placebo it was about 2 percent. Many patients on PTH were able to stop active vitamin D entirely. 1
The trial did not show better urinary calcium, which some had hoped for. Later analyses of blood calcium through the day showed considerable swings. These gaps are part of why palopegteriparatide was developed. It is a longer-acting successor. 1
Evidence checklist
- Randomised controlled trial REPLACE, double-blind, placebo-controlled
- Human study over 100 people REPLACE 134 adults
- More than one research group One pivotal trial cited
- Clinical outcomes, not surrogate markers Lower supplement need; calcium stayed in range
- Human safety data beyond case reports Trial data and osteosarcoma boxed warning
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Citations
- Mannstadt 2013, Lancet Diabetes Endocrinol: efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE) doi.org
- Takeda 2022: statement on discontinuing manufacturing of Natpar/Natpara at the end of 2024 takeda.com
Reference information only, not medical advice. Drawn from the Parathyroid hormone article, fact-checked against the cited sources. No dosing anywhere on this site.