Bone Properties in Hypoparathyroidism: Effects of PTH

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John P. Bilezikian, Columbia University
ClinicalTrials.gov Identifier:
NCT00473265
First received: May 14, 2007
Last updated: February 12, 2013
Last verified: February 2013

May 14, 2007
February 12, 2013
September 2005
January 2011   (final data collection date for primary outcome measure)
Improvement in calcium homeostasis, as evidenced by a reduction in requirements for calcium supplementation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00473265 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bone Properties in Hypoparathyroidism: Effects of PTH
Bone Properties in Hypoparathyroidism: Effects of PTH

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypoparathyroidism
Drug: PTH
100mcg of PTH1-84 every other day, every day, or every three days
Other Names:
  • teriparatide
  • Preotact
  • PTH
  • PTH1-84
  • rhPTH
  • Natpara
No Intervention: no intervention
participants receive open-label PTH1-84 in another study that they participate in. This study however does not provide or otherwise utilize an intervention or study arms of any kind, yet the story of this study would be incomplete withouth mentioning the use of PTH1-84 in the other study.
Intervention: Drug: PTH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
43
November 2013
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hypoparathyroidism

Exclusion Criteria:

  • Bisphosphonate use
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00473265
AAAA5457, R01DK069350
No
John P. Bilezikian, Columbia University
John P. Bilezikian
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: John P Bilezikian, MD Columbia University
Columbia University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP