Balance Study: A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
PI: Dr Narendra Reddy
Study start date: June 2017
Hypoparathyroidism is a rare condition where the parathyroid glands – which are in the neck, near the thyroid gland – produce too little parathyroid hormone. This makes blood calcium levels fall (hypocalcaemia) and blood phosphorus levels rise (hyperphosphataemia). This can cause a wide range of symptoms, including muscle cramps, numbness, joint and bone pain, brain fog and depression. Current treatment for hypoparathyroidism involves taking calcium and active vitamin D supplements, usually for life.
The Balance study will compare the usual treatment of supplements with an additional medication that can be taken alongside the supplements to see if the new treatment helps to control symptoms better.
Patients on the Balance study will be trialling a medication called recombinant human parathyroid hormone- rhPTH(1-84). They will be receiving either the medication or a placebo (which looks like the medication but contains no active ingredients) which they can inject themselves using an injection pen.
Participants will have their physical and mental health closely monitored and analysed using questionnaires that are uploaded to tablets and smartphones on a daily basis. Participants remain on the study for approximately 8 months, including follow-up time.
For more information contact the Research Space team on 0116 258 5973 or visit: https://www.endocrineweb.com/clinical-trials/parathyroid-diseases/60538-hypoparathyroid-balance-study