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Last Updated: April 19, 2024

CLINICAL TRIALS PROFILE FOR NATPARA


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All Clinical Trials for NATPARA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00473265 ↗ Bone Properties in Hypoparathyroidism: Effects of PTH Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2/Phase 3 2004-05-01 Whereas much information is known about the properties of bone in primary hyperparathyroidism, a disorder of parathyroid hormone (PTH) excess, virtually nothing is known about the skeleton in hypoparathyroidism, a disorder in which PTH is absent. The purpose of this research project is to test the hypothesis that the skeleton in hypoparathyroidism is abnormal in its metabolic, densitometric, geometric, biomechanical and microarchitectural features. We will also test the hypothesis that the skeleton is dependent upon PTH for normal structure and function. Using non-invasive approaches as well as direct analysis of bone itself, the human hypoparathyroid skeleton will be thoroughly characterized. With each patient serving as his/her own control, we will determine how, to what extent, and in what ways the administration of PTH restores skeletal dynamics and structure to the hypoparathyroid skeleton. In this way, we will identify those structural and dynamic elements of the skeleton that are influenced by or dependent upon PTH. Methods to be utilized include dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microCT methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and Fourier Transform Infrared Spectroscopy. This research project will extend our knowledge of the skeletal effects of PTH to its deficient range and thus complete our understanding of PTH action on bone gained by our many years of studying PTH overexpression in primary hyperparathyroidism. This investigation may also provide insight into the means by which PTH helps to restore the skeleton when it is used to treat osteoporosis.
NCT00473265 ↗ Bone Properties in Hypoparathyroidism: Effects of PTH Completed John P. Bilezikian Phase 2/Phase 3 2004-05-01 Whereas much information is known about the properties of bone in primary hyperparathyroidism, a disorder of parathyroid hormone (PTH) excess, virtually nothing is known about the skeleton in hypoparathyroidism, a disorder in which PTH is absent. The purpose of this research project is to test the hypothesis that the skeleton in hypoparathyroidism is abnormal in its metabolic, densitometric, geometric, biomechanical and microarchitectural features. We will also test the hypothesis that the skeleton is dependent upon PTH for normal structure and function. Using non-invasive approaches as well as direct analysis of bone itself, the human hypoparathyroid skeleton will be thoroughly characterized. With each patient serving as his/her own control, we will determine how, to what extent, and in what ways the administration of PTH restores skeletal dynamics and structure to the hypoparathyroid skeleton. In this way, we will identify those structural and dynamic elements of the skeleton that are influenced by or dependent upon PTH. Methods to be utilized include dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microCT methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and Fourier Transform Infrared Spectroscopy. This research project will extend our knowledge of the skeletal effects of PTH to its deficient range and thus complete our understanding of PTH action on bone gained by our many years of studying PTH overexpression in primary hyperparathyroidism. This investigation may also provide insight into the means by which PTH helps to restore the skeleton when it is used to treat osteoporosis.
NCT02781844 ↗ Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism Completed Shire Phase 1 2017-04-03 This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara® and in the EU as Natpar).
NCT02986607 ↗ Corticosteroid Rhythms in Hypoparathyroid Patients Unknown status Haukeland University Hospital Early Phase 1 2016-03-01 The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality of life. The main objective of the current study is to test if PTH deficiency influences the secretion of corticosteroids and whether any abnormalities in the HPA-axis and the RAAS-system can be reversed by PTH infusion.
NCT02986607 ↗ Corticosteroid Rhythms in Hypoparathyroid Patients Unknown status University of Bergen Early Phase 1 2016-03-01 The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality of life. The main objective of the current study is to test if PTH deficiency influences the secretion of corticosteroids and whether any abnormalities in the HPA-axis and the RAAS-system can be reversed by PTH infusion.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NATPARA

Condition Name

Condition Name for NATPARA
Intervention Trials
Hypoparathyroidism 4
Hyperparathyroidism 1
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Condition MeSH

Condition MeSH for NATPARA
Intervention Trials
Hypoparathyroidism 4
Hyperparathyroidism 1
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Clinical Trial Locations for NATPARA

Trials by Country

Trials by Country for NATPARA
Location Trials
United States 11
Hungary 2
Israel 1
Canada 1
Norway 1
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Trials by US State

Trials by US State for NATPARA
Location Trials
New York 2
Tennessee 1
Pennsylvania 1
Ohio 1
Minnesota 1
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Clinical Trial Progress for NATPARA

Clinical Trial Phase

Clinical Trial Phase for NATPARA
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for NATPARA
Clinical Trial Phase Trials
Completed 3
Unknown status 1
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Clinical Trial Sponsors for NATPARA

Sponsor Name

Sponsor Name for NATPARA
Sponsor Trials
University of Bergen 1
Entera Bio Ltd. 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1
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Sponsor Type

Sponsor Type for NATPARA
Sponsor Trials
Other 3
Industry 2
NIH 1
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