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HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism

NCT01199614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-07-05

Study results available
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Summary

This is an open-label study of PTH(1-84) treatment that seeks:

1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and urinary calcium excretion with use of standard amounts of calcium and vitamin D supplementation.
2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis.
3. To establish the safety of PTH(1-84) when administered for up to 12 years.
4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism post PTH administration.

There will be one visit conducted every six months in the study offices of the principal investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local Quest Lab performed to ensure stability prior to Baseline.

Conditions

  • Hypoparathyroidism

Interventions

DRUG

open-label PTH(1-84)

open label PTH(1-84) at either 25mcg every other day, 25mcg every day, 50mcg daily, 75mcg daily, or 100mcg daily

Sponsors & Collaborators

Principal Investigators

  • John P Bilezikian, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2017-06-26
Completion
2017-06-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199614 on ClinicalTrials.gov