Each participant will be in the study for approximately 29-33 weeks (about 8 months).
Up to approximately 150 people with hypoparathyroidism around the world will participate in the BALANCE study. You may be eligible to join the BALANCE study if you:
There are other criteria you must meet in order to participate. The study staff will discuss these criteria with you.
The investigational medication in the BALANCE study, called recombinant human parathyroid hormone (rhPTH[1-84]), is taken once-daily with an injection pen. In this study, rhPTH(1-84) will be compared to placebo, which looks like rhPTH(1-84) but contains no active ingredients. Participants in the study will be randomly assigned (like flipping a coin) to receive either rhPTH(1-84) or placebo. Placebos are used to help evaluate the investigational medication by comparing the effects seen in study participants who take the investigational medication versus those who take placebo. This is done to account for what is called the “placebo effect,” which is any effect of participation in the study that is not a result of the investigational medication itself.
All study participants will also receive the standard therapy for hypoparathyroidism, which consists of oral calcium and active vitamin D tablets, as needed.
Neither you nor the study doctor will know if you’re receiving rhPTH(1-84) or placebo. However, the study doctor will be able to obtain this information in case of an emergency.
If you are eligible and choose to participate in the BALANCE study, you will be required to attend all study visits and follow instructions from the study staff. Your participation will last approximately 29-33 weeks and include up to 16 study visits and 3 phone calls with the study staff. At study visits, the study staff will perform study-related tests and procedures and ask you to answer questions about your health. You will also be required to inject your rhPTH(1-84) or placebo into your thigh once every day using an injection pen. There are additional study requirements which the study staff will discuss with you in detail.