A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)

Summary

Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism. In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment. Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant. The study doctors will also check for side effects from the study treatments. After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.

Timeline

Start

2018-01-24

Primary completion

2022-05-19

Completion

2022-05-19

Publications

• Wang S, Rockwood NJ, Yarr S, Korver D, Castriota F, Martin S, Ayodele O. Psychometric Evaluation of the Hypoparathyroidism Symptom Diary: Data from a Prospective Phase 3b/4 Study. Patient Relat Outcome Meas. 2026 Mar 10;16:539994. doi: 10.2147/PROM.S539994. eCollection 2025.
• Brandi ML, Vokes T, Appelman-Dijkstra NM, Ayodele O, Decallonne B, de Jongh R, Diaz-Curiel M, Fraser W, Finkelman RD, Heck A, Ing SW, Kamenicky P, Khan AA, Kovacs CS, Lapauw B, Leese G, Mantovani G, Martinez Diaz-Guerra G, Masi L, Melo M, Palermo A, Reddy NL, Rejnmark L, Tokareva E, Vantyghem MC, Wang S, Warren M, Yan B. rhPTH(1-84) for hypoparathyroidism: a randomized study of patient-reported outcomes. Eur J Endocrinol. 2025 Jul 31;193(2):310-319. doi: 10.1093/ejendo/lvaf148.

Drugs

Indications