HypoparathyroidismNATPARA KABNCT05556629
A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA
An observational study of Hypoparathyroidism, run by Shire at 1 site in United States.
Trial summary
This main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and prescribing physicians regarding the risks and safe use of NATPARA. The survey will be done via internet, telephone, or paper and participants will be able to choose the method that is preferred. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have been approved for NATPARA and a part of the SUP program prior to survey implementation and prescribing physicians who can provide a 10-digit NPI number and who are certified in the NATPARA REMS by successfully completing the NATPARA REMS program training module for prescribing physicians, including the knowledge assessment, and submitting a NATPARA REMS program prescribing physician enrollment form are eligible for participation in the survey.
Participant inclusion criteria:
- Participants who are 18 years of age or older and who have been approved for NATPARA and a part of the SUP Program prior to survey implementation are eligible to participate in the survey.
- A caregiver may participate in this survey on behalf of a participant who is a part of the SUP Program and who is eligible but unable to complete the survey.
Prescribing physician inclusion criteria:
- HCPs in the United States (US) who can provide a 10-digit NPI number and who are certified in the NATPARA REMS by successfully completing the NATPARA REMS Program Training Module for Prescribing Physicians, including the Knowledge Assessment, and submitting a NATPARA REMS Program Prescribing Physician Enrollment Form are eligible for participation in the survey and a part of the SUP Program.
Participant and Prescribing Physician exclusion criteria:
- Respondents who do not agree to participate in the survey will be excluded.
- Survey respondents who have been employed or whose immediate family members have been employed by NPS, Shire, Takeda, United BioSource LLC, (UBC), or the Food and Drug Administration (FDA) are not eligible to participate in the survey and will be excluded.
- Respondents who reported having a conflict of interest will be excluded.
- Respondents who are not part of the SUP program will be excluded.
Participant exclusion criteria:
- Participants who do not agree to participate in the survey will be excluded.
- Participants who have opted out of receiving communications will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda)
Lexington, Massachusetts
About this study
Official title: Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for Injection, for Subcutaneous Use
This main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and prescribing physicians regarding the risks and safe use of NATPARA. The survey will be done via internet, telephone, or paper and participants will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.
- Conditions
- Hypoparathyroidism
- Being tested
- No Intervention
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| NATPARA: Participants | Participants who have been approved for NATPARA and a part of the special use program (SUP) prior to survey implementation will participate in the survey via telephone or internet. Receives: Other: No Intervention | |
| NATPARA: Healthcare Provider (Prescribing Physician) | Healthcare provider (HCPs)/Prescribing physician who can provide a 10-digit National Provider Identifier (NPI) number and who are certified in the NATPARA risk evaluation and mitigation strategy (REMS) by successfully completing the NATPARA REMS program training module for prescribing physicians, including the knowledge assessment, and submitting a NATPARA REMS Program Prescriber Enrollment Form will participate in the survey via telephone or internet. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants and Prescribing Physicians Providing Correct Responses to Questions
All question for key risk message and about NATPARA will be asked through a questionnaire, Participant or prescribing physicians (HCPs) would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
Measured: Up to approximately 7 years
Secondary outcomes (2)
Number of Participants and Prescribing Physicians Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages
The questions will be asked to participants and HCPs will be counted as correct if 80% of the correct responses are provided and not more than one incorrect response is provided. In key risk message, general question about NATPARA will be asked, participant or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
Measured: Up to approximately 7 years
Number of Participants and Prescribing Physicians who Demonstrated Understanding of Each key Risk Messages
Understanding demonstration is defined as respondents who answered 80% or more questions/items in a key risk message correctly. In key risk message, general question about NATPARA will be asked, participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
Measured: Up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Sep 2015
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556629
- Sponsor's protocol ID
- TAK-834-4008
- Other IDs
- EUPAS48713
- Acronym
- NATPARA KAB
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for Injection, for Subcutaneous Use
- ClinicalTrials.gov ID
- NCT05556629
- Acronym / sponsor ID
- NATPARA KAB / TAK-834-4008
- Conditions
- Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and prescribing physicians regarding the risks and safe use of NATPARA. The survey will be done via internet, telephone, or paper and participants will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NATPARA: Participants | – | Other: No InterventionParticipants who have been approved for NATPARA and a part of the special use program (SUP) prior to survey implementation will participate in the survey via telephone or internet. |
| NATPARA: Healthcare Provider (Prescribing Physician) | – | Other: No InterventionHealthcare provider (HCPs)/Prescribing physician who can provide a 10-digit National Provider Identifier (NPI) number and who are certified in the NATPARA risk evaluation and mitigation strategy (REMS) by successfully completing the NATPARA REMS program training module for prescribing physicians, including the knowledge assessment, and submitting a NATPARA REMS Program Prescriber Enrollment Form will participate in the survey via telephone or internet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been approved for NATPARA and a part of the SUP program prior to survey implementation and prescribing physicians who can provide a 10-digit NPI number and who are certified in the NATPARA REMS by successfully completing the NATPARA REMS program training module for prescribing physicians, including the knowledge assessment, and submitting a NATPARA REMS program prescribing physician enrollment form are eligible for participation in the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | NATPARA: Healthcare Provider (Prescribing Physician), NATPARA: Participants |
Primary outcome
Number of Participants and Prescribing Physicians Providing Correct Responses to Questions
Time frame: Up to approximately 7 years
All question for key risk message and about NATPARA will be asked through a questionnaire, Participant or prescribing physicians (HCPs) would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
2 secondary outcomes
Number of Participants and Prescribing Physicians Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages
Time frame: Up to approximately 7 years
Number of Participants and Prescribing Physicians who Demonstrated Understanding of Each key Risk Messages
Time frame: Up to approximately 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Shire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants and Prescribing Physicians Providing Correct Responses to Questions (time frame: Up to approximately 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.