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Parathyroid Hormone Analog

ADD-ON Study to Existing Hypoparathyroidism Studies

Phase 3
Waitlist Available
Led By John P Bilezikian, MD
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 variable depending on parent study
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group

Summary

The purpose of this protocol is to add on additional exploratory studies to investigate changes in bone quality parameters with PTH(1-84) treatment of hypoparathyroidism. In addition to the biochemical hallmarks of hypoPT, it has been found that the microscopic structure of the bone, as well as the bone remodeling system, are markedly abnormal in this disease. How these abnormalities may be corrected with PTH(1-84) administration are not fully understood. The studies outlined in this add-on protocol are designed to shed light on the mechanistic ways that PTH(1-84) replacement may restore normal bone metabolism. These mechanistic studies are beyond the scope of the parent NPS study, which was designed to assess the safety and efficacy of PTH(1-84) in hypoPT treatment. Subjects who are participating in the NPS' REPLACE, RELAY, and RACE Studies and the HEXT Study at Columbia University will be invited to participate in this add-on protocol, which will involve a separate IRB-approved informed consent. Study procedures: 1. High Resolution Peripheral Quantitative Computed Tomography (HRpQCT; XtremeCT, Scanco): Done at the same visit as DXA. In the REPLACE study twice, in RELAY once (or not at all if done within the last 6 months), in RACE twice, and in HEXT three times. 2. Osteolineage: At Baseline/Randomization/Visit One and at 4, 8, 12, 24, and 52 weeks of treatment in the REPLACE, RELAY, or RACE Study, if applicable, or at baseline and each 6-months visit in the HEXT Study, blood test for circulating osteogenic cells (10 cc) will be performed 3. Sclerostin: At Baseline/Randomization/Visit One and at 4, 8, 12, 24, and 52 weeks of treatment in the REPLACE, RELAY, or RACE Study, if applicable, or at baseline and each 6-months visit in the HEXT Study, blood test for sclerostin (5cc) will be performed Funding Source - FDA OOPD

Eligible Conditions
  • Hypoparathyroidism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HRpQCT
circulating osteogenic precursors
sclerostin

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PTH1-84 in parent studyExperimental Treatment1 Intervention
In the RELAY, RACE, and HEXT study participants utilize PTH1-84. In the REPLACE Study participants utilize PTH1-84 or placebo of PTH1-84.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,464 Previous Clinical Trials
4,337,391 Total Patients Enrolled
1 Trials studying Hypoparathyroidism
68 Patients Enrolled for Hypoparathyroidism
John P Bilezikian, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
138 Total Patients Enrolled
2 Trials studying Hypoparathyroidism
130 Patients Enrolled for Hypoparathyroidism
~4 spots leftby Jan 2026