Clinical Trial 39818

Columbus, OH 43203


Study Summary:

Do you have hypoparathyroidism? You may qualify for a new clinical research study.

Living with hypoparathyroidism can be complicated. Your health concerns are personalized to your situation, and a treatment plan that is right for someone else may not be right for you. Clinical research is needed to continue to develop new treatment options that may work better for a number of people worldwide living with hypoparathyroidism.

If you or a family member have hypoparathyroidism, you may want to consider participating in the BALANCE clinical research study.

What is the purpose of the BALANCE clinical research study?

The BALANCE study is evaluating whether adding an investigational medication called recombinant human parathyroid hormone (rhPTH[1-84]) to standard hypoparathyroidism therapy (oral calcium and active vitamin D tablets) may help control the symptoms of hypoparathyroidism better than standard therapy alone.

What is the investigational medication?

The investigational medication in the BALANCE study, called 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. All study participants will also receive the standard therapy for hypoparathyroidism, which consists of oral calcium and active vitamin D tablets, as needed.

Who can participate?

You may be eligible to join the BALANCE study if you:

  • Are 18 to 85 years old
  • Have had hypoparathyroidism for at least 12 months
  • Have two or more symptoms related to hypoparathyroidism
There are other eligibility criteria that you must meet in order to participate. The study staff will discuss these criteria and the potential risks and benefits of participating in the study with you in greater detail.

How long is the study?

If you qualify for and decide to participate in the BALANCE study, your participation will last approximately 29-33 weeks and include up to 16 study visits and 3 phone calls with the study staff.


Study is Available At:

To learn more about the BALANCE study or to see if you may be eligible to participate, visit www.BALANCEHypoparathyroidismStudy.com

Click here for a list of study sites.

 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.