Bone Properties in Hypoparathyroidism: Effects of PTH

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John P. Bilezikian, Columbia University
ClinicalTrials.gov Identifier:
NCT00473265
First received: May 14, 2007
Last updated: July 14, 2015
Last verified: July 2015
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Columbia University:

Primary Outcome Measures:
  • Requirements for Calcium Supplementation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).

  • Trabecular Width [ Time Frame: baseline versus two years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
  • PTH
  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypoparathyroidism

Exclusion Criteria:

  • Bisphosphonate use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473265

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
John P. Bilezikian
Investigators
Principal Investigator: John P Bilezikian, MD Columbia University
  More Information

No publications provided

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
Study First Received: May 14, 2007
Results First Received: October 23, 2013
Last Updated: July 14, 2015
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Hypoparathyroidism
Endocrine System Diseases
Parathyroid Diseases

ClinicalTrials.gov processed this record on August 27, 2015