A Registry for Participants With Chronic Hypoparathyroidism

  • STATUS
    Recruiting
  • End date
    Nov 30, 2034
  • participants needed
    900
  • sponsor
    Shire
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Updated on 24 January 2021
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Investigator
Shire Contact
Primary Contact
Model Clinical Research (9.3 mi away) Contact
+106 other location

Summary

This is a prospective, observational disease and drug registry designed to evaluate the safety and effectiveness profile of rhPTH(1-84) under conditions of routine clinical practice and to observe the clinical course of chronic hypoparathyrodism. No treatment is provided as a result of participating in this registry and all decisions on the participant's treatment are determined by his or her physician.

Details
Treatment None [Natural history registry], None [Disease and drug registry], Combination product (Natpara) and drug or supplements [Disease and drug registry]
Clinical Study IdentifierNCT01922440
SponsorShire
Last Modified on24 January 2021

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Eligibility

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Inclusion Criteria

Gender: Male or Female
Do you have Chronic Hypoparathyroidism?
Do you have any of these conditions: Do you have Chronic Hypoparathyroidism??
Participants diagnosed with chronic hypoparathyroidism, ie, hypoparathyroidism with a duration of longer than 6 months, including
Adult participants (greater than or equal to [>=] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone
Pediatric participants (less than [<] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone

Exclusion Criteria

Participants or legally acceptable representatives unable to provide informed consent
Participants using rhPTH(1-34) or used rhPTH(1-34) for more than 2 years and in the last 3 months
Participants currently enrolled in an interventional clinical study (whether or not the study is related to hypoparathyroidism). Note that this does not include participants enrolled in other observational registries
History of hypoparathyroidism resulting from a known activating mutation in the CaSR gene
History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism)
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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