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ADD-ON Study to Existing Hypoparathyroidism Studies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00856401
First Posted: March 5, 2009
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John P Bilezikian, MD, Columbia University
  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: Intervention Model: Single Group Assignment
Masking: None (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 John P Bilezikian, MD, Columbia University:

Primary Outcome Measures:
  • HRpQCT [ Time Frame: before and after treatment ]
    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 ]
    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 ]
    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.


Enrollment: 62
Study Start Date: September 2010
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856401


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: John P Bilezikian, MD Columbia University
  More Information

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 ( Other Grant/Funding Number: FDA )
CFDA 93.103 ( Registry Identifier: CFDA 93103 )
FDA-002525-04A1 ( Other Identifier: FDA - OOPD )
First Submitted: March 4, 2009
First Posted: March 5, 2009
Last Update Posted: September 22, 2017
Last Verified: September 2017

Keywords provided by John P Bilezikian, MD, Columbia University:
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
Parathyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs