ADD-ON Study to Existing Hypoparathyroidism Studies

NCT00856401 | Unknown Phase 3 DMC

• 3 other identifiers: CFDA 93.103NIH application ID 7566998FDA-002525-04A1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Conditions

Hypoparathyroidism

Keywords

hypoparathyroidism; hypopara; PTH; parathyroid hormone; CL-11-040; CL1-11 Study; NPSP 558; RELAY; RACE; REPLACE; HEXT; c10-007; c10-008; NPSP558; Columbia study; Columbia studies; HPTH; PTH1-84

Outcome Measures

Primary Outcomes (3)

• HRpQCT

  HPpQCT is performed twice in the REPLACE Study, one at Baseline, and again at 6 months. In the RELAY Study it is performed once at baseline, and only if it has not be done within the last 6 months. In the RACE study it is performed twice, once at baseline, then again at 52 weeks. In the HEXT study it is performed three times, once at baseline, then at 12 and 24 months.

  before and after treatment

• 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. 5cc per draw.

  variable depending on parent study

• circulating osteogenic precursors

  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. 10cc per draw.

  variable depending on parent study

Study Arms (1)

PTH1-84 in parent study

EXPERIMENTAL

In the RELAY, RACE, and HEXT study participants utilize PTH1-84. In the REPLACE Study participants utilize PTH1-84 or placebo of PTH1-84.

Drug: PTH1-84 in parent study

Interventions

PTH1-84 in parent study DRUG

daily injection of rhPTH(1-84); 25, 50 75, or 100mcg in parent study. In ADD-ON study, there is no intervention, only testing.

Also known as: PTH1-84, PTH(1-84), rhPTH1-84, rhPTH(1-84), recombinant human parathyroid hormone 1-84

PTH1-84 in parent study

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• active participation in the CL1-11-040, PAR-C10-007 or PAR-C10-008 Studies sponsored by NPS Pharmaceuticals.
• active participation in the HEXT Study of Dr. John Bilezikian.

You may not qualify if:

• \- not being a participant of the CL1-11-040, PAR-C10-007 or PAR-C10-008 Studies sponsored by NPS Pharmaceuticals or the HEXT Study of Dr. John Bilezikian.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hypoparathyroidism

Interventions

Parathyroid Hormone

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• John P Bilezikian, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: September 1, 2010
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)