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Trial record 14 of 94 for:    hypoparathyroidism

Bone Properties in Hypoparathyroidism: Effects of PTH

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473265
First Posted: May 15, 2007
Last Update Posted: July 16, 2015
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
John P. Bilezikian, Columbia University
  Purpose
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.

Condition Intervention Phase
Hypoparathyroidism Drug: PTH Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Properties in Hypoparathyroidism: Effects of PTH

Resource links provided by NLM:


Further study details as provided by John P. Bilezikian, Columbia University:

Primary Outcome Measures:
  • Requirements for Calcium Supplementation [ Time Frame: 2 years ]
    Serum and urinary calcium levels maintained by change in requirements for calcium supplementation


Secondary Outcome Measures:
  • Percent Change in BMD From Baseline to 24 Months by DXA [ Time Frame: baseline versus 24 months ]
    Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).

  • Trabecular Width [ Time Frame: baseline versus two years ]
    Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.

  • Trabecular Number [ Time Frame: baseline versus two years ]
    trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.

  • Cortical Porosity [ Time Frame: baseline versus two years ]
    Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.

  • Mineralizing Surface [ Time Frame: baseline versus one year ]
    Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.


Enrollment: 68
Study Start Date: May 2004
Study Completion Date: June 2014
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTH(1-84)
100mcg of PTH1-84 every other day, every day, or every three days
Drug: PTH
Other Names:
  • teriparatide
  • Preotact
  • PTH1-84
  • rhPTH
  • Natpara

Detailed Description:
A detailed description of the methods used in this study include the following: direct analysis of bone itself. skeletal dynamics and structure such as 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypoparathyroidism

Exclusion Criteria:

  • Bisphosphonate use
  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): NCT00473265


Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
John P. Bilezikian
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, Dorothy L. and Daniel H. Silberberg Professor of Medicine and Pharmacology, Columbia University
ClinicalTrials.gov Identifier: NCT00473265     History of Changes
Other Study ID Numbers: AAAA5457
R01DK069350 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2007
First Posted: May 15, 2007
Results First Submitted: October 23, 2013
Results First Posted: July 16, 2015
Last Update Posted: July 16, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs