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Parathyroid Hormone Analog

open-label PTH(1-84) for Hypoparathyroidism

Phase 3
Waitlist Available
Led By John P Bilezikian, MD
Research Sponsored by John P. Bilezikian
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs. up to 12 years
Awards & highlights

Study Summary

This is an open-label study of PTH(1-84) treatment that seeks: 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. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis. To establish the safety of PTH(1-84) when administered for up to 12 years. 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs. up to 12 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs. up to 12 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Dose of Calcium Supplementation
Secondary outcome measures
Percent Change in BMD by DXA

Trial Design

1Treatment groups
Experimental Treatment
Group I: open-label PTH(1-84)Experimental Treatment1 Intervention
open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day

Find a Location

Who is running the clinical trial?

NPS PharmaIndustry Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
ShireIndustry Sponsor
456 Previous Clinical Trials
97,217 Total Patients Enrolled
12 Trials studying Hypoparathyroidism
1,993 Patients Enrolled for Hypoparathyroidism
John P. BilezikianLead Sponsor
2 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Hypoparathyroidism
68 Patients Enrolled for Hypoparathyroidism

Frequently Asked Questions

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~5 spots leftby May 2025