Trial record 6 of 49 for:
hypoparathyroidism
ADD-ON Study to Existing Hypoparathyroidism Studies
This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
John P Bilezikian, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT00856401
First received: March 4, 2009
Last updated: February 22, 2013
Last verified: February 2013
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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:
- 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.
- 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
- 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
| 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:
|
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 Study 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 Study sponsored by NPS Pharmaceuticals or the HEXT Study of Dr. John Bilezikian.
Contacts and Locations 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 |
| Study First Received: | March 4, 2009 |
| Last Updated: | February 22, 2013 |
| 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 Parathyroid Diseases Endocrine System Diseases Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013