A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA

NCT ID: NCT05556629

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoparathyroidism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

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.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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.


• 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.

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.


* Participants who do not agree to participate in the survey will be excluded.
* Participants who have opted out of receiving communications will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role collaborator

Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Shire

Locations

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Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda)

Lexington, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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EUPAS48713

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-834-4008

Identifier Type: -

Identifier Source: org_study_id

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