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

NCT05556629 | Completed FDA Drug

• 2 other identifiers: TAK-834-4008EUPAS48713
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. No study medicines will be provided to patients in this study.

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to approximately 7 years

• Number of Participants and Prescribing Physicians who Demonstrated Understanding of Each key Risk Messages

  Up to approximately 7 years

Study Arms (2)

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.

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.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

NATPARA: Healthcare Provider (Prescribing Physician); NATPARA: Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (1)

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

Lexington, Massachusetts, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Study Director

  Shire

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: September 1, 2015
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)