Hypoparathyroid BALANCE Study

If you have been diagnosed with hypoparathyroid disease, would you consider participating in a clinical research trial of a new treatment?

Living with hypoparathyroidism can be a challenge for most patients. Your health concerns are best addressed through a  personalized treatment plan. Clinical research is necessary to develop new treatment options that may work better for a number of people living with this disorder.

If you or a family member have hypopararthyroid disease, you may want to consider becoming part of the BALANCE clinical study.

What Is the Purpose of the BALANCE Research Study?

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

Clinical research studies (also called clinical trials) test the safety and efficacy of possible new medications. many treatments used today are possible because they were tested in a clinical study in the past.

What is the Investigational Medication?

The treatment to be tested 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 a 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 the placebo. All study participants will also receive the standard therapy for hypoparathyroidism, which consists of oral calcium and/or active vitamin D tablets, as needed. 

Why Might You Consider Joining This Clinical Study?

People participate in clinical research studies for a variety of reasons. Some may decide to join a study because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about the disease so that it may help others in the future.

If you choose to participate in the Balance study, your hypoparathyroidism will be closely monitored under the guidance of the study doctor. Participating in clinical research can be challenging. Speak with the study doctor about any questions you may have and let the study doctor know if you expect any challenges to participating in the study. 

Can You Participate?

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

  • You are 18 to 85 years old
  • You have had chronic hypoparathyroidism for at least 12 months
  • You have two or more symptoms related to hypoparathyroidism

Study participation is completely voluntary. There are a few more eligibility requirements that must be met in order for you to participate. These will be discussed with you when you meet with the study staff as they will also take the time to discuss the potential risks and benefits of participating in the study in greater detail.

How Long Is the Study? 

If you qualify for and decide to participate in the Balance study, your participation is completely voluntary, and is expected to last for approximately 29-33 weeks (or about 8 months), which will include up to 16 visits and 4 phone calls with the study team. All of the study 

To learn more about the BALANCE study or to find out if you are eligible to participate, visit: Balance Hypoparathyroidism Study.

Clinical Trial Sponsor

This clinical trial is sponsored by Shire Pharmaceuticals.

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