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Active not recruitingOBSERVATIONAL

A Registry for Participants With Chronic Hypoparathyroidism

This study aims to understand the long-term safety and effectiveness of a specific treatment called rhPTH(1-84) (recombinant human parathyroid hormone) for people with long-term hypoparathyroidism. This condition means your body doesn't make enough parathyroid hormone. The study will look at how this treatment works in real-life medical care, without asking participants to change their current treatment plan. Instead, participants will continue their usual care under their doctors' guidance. Anyone of any age with chronic hypoparathyroidism (meaning it's lasted over six months) who is currently receiving treatment, including rhPTH(1-84) or other standard therapies, can be considered. This study is mainly about collecting information through questionnaires during regular doctor's appointments.

At a glance

Status
Active not recruiting
Sponsor
Takeda
Enrolment target
1,339
Start
30 Jul 2013
Estimated completion
30 Nov 2034

What is this study about?

This study is called a 'registry,' which means it's like a long-term collection of information about people with chronic hypoparathyroidism. The main goal is to understand more about how a particular treatment called rhPTH(1-84) works over a long period. We want to see how safe it is and how effective it is for patients in their everyday lives, as part of their regular care.

Your doctors will continue to manage your treatment as they normally would. This study won't ask you to change your medication or how you take it. Instead, it's about observing and recording what happens under normal medical practice. You'll simply fill out a questionnaire during one of your regular check-ups with your doctor.

This research is important because it helps doctors and scientists gather real-world information about treatments. This kind of information can help improve how people with chronic hypoparathyroidism are cared for in the future.

Key takeaways

  • This study helps understand a treatment for chronic hypoparathyroidism.
  • It's about collecting information during routine care, not changing it.
  • Participation involves filling out a questionnaire during a normal doctor's visit.
  • Both adults and children with long-term hypoparathyroidism can take part.
  • Your medical treatment will continue as usual.
  • The information gathered could help improve future care for patients.

Who may be eligible?

To be able to join this study, you must have been diagnosed with chronic hypoparathyroidism, meaning you've had it for more than six months. You can be an adult (18 years or older) or a child (under 18 years old).

Crucially, you must already be receiving treatment for your hypoparathyroidism. This could be standard care, a combination of standard care and the rhPTH(1-84) treatment, or just the rhPTH(1-84) treatment by itself.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I have chronic hypoparathyroidism (for more than 6 months).
  2. I am currently receiving some form of treatment for my hypoparathyroidism.
  3. I am not currently in another study that involves an experimental treatment.
  4. My hypoparathyroidism is not due to my body not responding properly to parathyroid hormone (pseudohypoparathyroidism).
Answer every question to see your result.

What does participation involve?

If you decide to join this study, your regular medical care for hypoparathyroidism will not change. You will continue to see your doctor and receive your treatment as you normally would. The only additional step for the study is that you'll be asked to fill out a questionnaire during one of your routine doctor's visits. There are no extra hospital visits, new medications, or follow-up appointments specifically for the study. The total duration of your participation would depend on how long the registry continues and your ongoing treatment.

Potential risks and benefits

There are no direct medical risks from joining this study, as you will continue with your usual treatment. The main benefit is that the information collected from you and other participants will help doctors and researchers understand more about chronic hypoparathyroidism and its treatments, potentially leading to better care for everyone in the future. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (100)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham
    Verified postcode
    Birmingham, United States
  • University of Arizona Medical Center
    Verified postcode
    Tucson, United States
  • Children's Hospital Los Angeles
    Verified postcode
    Los Angeles, United States
  • Cedars-Sinai Medical Center
    Verified postcode
    Los Angeles, United States
  • Dr. Joselito Cabaccan
    Verified postcode
    San Jose, United States
  • University of Colorado Hospital
    Verified postcode
    Aurora, United States
  • Yale University
    Verified postcode
    New Haven, United States
  • Hanson Clinical Research Center
    Verified postcode
    Port Charlotte, United States
  • Thyroid & Endocrine Center of Florida
    Verified postcode
    Sarasota, United States
  • East-West Medical Research Institute
    Verified postcode
    Honolulu, United States
  • Suburban Endocrinology & Diabetes
    Verified postcode
    Arlington Heights, United States
  • University of Chicago Medical Center
    Verified postcode
    Chicago, United States

Common questions

What is chronic hypoparathyroidism?

It's a long-term condition where your body doesn't produce enough parathyroid hormone, which helps control calcium levels in your blood.

Will I have to take new medication if I join?

No, you will not have to take any new medication. You will continue with your current treatment as decided by your doctor.

How often will I need to see the doctor for this study?

You'll only fill out a questionnaire during one of your regular, scheduled doctor's visits, so there are no extra appointments.

What is rhPTH(1-84)?

It's a specific type of treatment that helps replace the parathyroid hormone your body isn't making enough of.

Can children join this study?

Yes, both adults and children over 18 and under 18 can be considered for this study, as long as they meet the other criteria.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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