ADD-ON Study to Existing Hypoparathyroidism Studies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John P Bilezikian, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT00856401
First received: March 4, 2009
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Hypoparathyroidism
Drug: PTH1-84 in parent study
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Trial of Parathyroid Hormone for the Treatment of Hypoparathyroidism

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • HRpQCT [ Time Frame: before and after treatment ] [ Designated as safety issue: No ]
    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.

  • sclerostin [ Time Frame: variable depending on parent study ] [ Designated as safety issue: No ]
    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.

  • circulating osteogenic precursors [ Time Frame: variable depending on parent study ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 62
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTH1-84 in parent study
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
daily injection of rhPTH(1-84); 25, 50 75, or 100mcg in parent study. In ADD-ON study, there is no intervention, only testing.
Other Names:
  • PTH1-84
  • PTH(1-84)
  • rhPTH1-84
  • rhPTH(1-84)
  • recombinant human parathyroid hormone 1-84

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856401

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: John P Bilezikian, MD Columbia University
  More Information

No publications provided

Responsible Party: John P Bilezikian, MD, MD, Columbia University
ClinicalTrials.gov Identifier: NCT00856401     History of Changes
Other Study ID Numbers: CFDA 93.103, NIH application ID 7566998, CFDA 93.103, FDA-002525-04A1
Study First Received: March 4, 2009
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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

Additional relevant MeSH terms:
Hypoparathyroidism
Endocrine System Diseases
Parathyroid Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014