Change in Dose of Calcium Supplementation
| Group | Value (percent change in dose) | Spread |
|---|---|---|
| Open-label PTH(1-84) | 37 | 43 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism
NCT01199614Dec 2009 to 26 Jun 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is an open-label study of PTH(1-84) treatment that seeks: 1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and urinary calcium excretion with use of standard amounts of calcium and vitamin D supplementation. 2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis. 3. To establish the safety of PTH(1-84) when administered for up to 12 years. 4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism post PTH administration. There will be one visit conducted every six months in the study offices of the principal investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local Quest Lab performed to ensure stability prior to Baseline.
Experimental
open-label PTH(1-84)
open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day
Outcomes the sponsor listed as primary.
Change in Dose of Calcium Supplementation
Time frame · Baseline, up to 4 years
Serum and urinary calcium levels maintained by change in requirements for calcium supplementation.
Percent Change in BMD by DXA
Time frame · Baseline, up to 4 years
Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DXA)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change in dose) | Spread |
|---|---|---|
| Open-label PTH(1-84) | 37 | 43 |
| Group | Value (percent change in BMD) | Spread |
|---|---|---|
| Open-label PTH(1-84) | 5.5 | 9 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Open-label PTH(1-84)open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day | 0 / 62 | 25 / 62 | 27 / 62 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Clinical trial · 2010
Rubin et al. 2010Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 85
PMID 20094706PMC2947814DOI 10.1007/s00198-009-1149-xPUB-20094706
7 studies on this page
PubMed tag: none · 2022
Ayodele et al. 2022Advances in therapycited by 10
PMID 36018496PMC9525348DOI 10.1007/s12325-022-02292-1PUB-36018496
PubMed tag: none · 2015
Cusano et al. 2015Expert review of endocrinology & metabolismcited by 20
PMID 25705243PMC4334142DOI 10.1586/17446651.2015.971755PUB-25705243
Indexing hint: Clinical trial · 2014
Cusano et al. 2014The Journal of clinical endocrinology and metabolismcited by 80
PMID 24978675PMC4184077DOI 10.1210/jc.2014-2267PUB-24978675
Indexing hint: Clinical trial · 2013
Cusano et al. 2013The Journal of clinical endocrinology and metabolismcited by 77
PMID 23162103PMC3537109DOI 10.1210/jc.2012-2984PUB-23162103
PubMed tag: none · 2013
Cusano et al. 2013The Journal of clinical endocrinology and metabolismcited by 89
PMID 23596139PMC3667253DOI 10.1210/jc.2013-1239PUB-23596139
Indexing hint: Clinical trial · 2011
Rubin et al. 2011Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 97
PMID 21735476PMC4019384DOI 10.1002/jbmr.452PUB-21735476
PubMed tag: none · 2010
Rubin et al. 2010Arquivos brasileiros de endocrinologia e metabologiacited by 36
PMID 20485912PMC3702727DOI 10.1590/s0004-27302010000200019PUB-20485912
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