- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473265
Bone Properties in Hypoparathyroidism: Effects of PTH
July 14, 2015 updated by: John P. Bilezikian
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hypoparathyroidism
Exclusion Criteria:
- Bisphosphonate use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PTH(1-84)
100mcg of PTH1-84 every other day, every day, or every three days
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Requirements for Calcium Supplementation
Time Frame: 2 years
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Serum and urinary calcium levels maintained by change in requirements for calcium supplementation
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in BMD From Baseline to 24 Months by DXA
Time Frame: baseline versus 24 months
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Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).
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baseline versus 24 months
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Trabecular Width
Time Frame: baseline versus two years
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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.
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baseline versus two years
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Trabecular Number
Time Frame: baseline versus two years
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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.
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baseline versus two years
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Cortical Porosity
Time Frame: baseline versus two years
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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.
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baseline versus two years
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Mineralizing Surface
Time Frame: baseline versus one year
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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.
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baseline versus one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John P Bilezikian, MD, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 14, 2007
First Submitted That Met QC Criteria
May 14, 2007
First Posted (Estimate)
May 15, 2007
Study Record Updates
Last Update Posted (Estimate)
July 16, 2015
Last Update Submitted That Met QC Criteria
July 14, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAA5457
- R01DK069350 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoparathyroidism
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Peking UniversityPeking Union Medical College Hospital; First Affiliated Hospital, Sun Yat-Sen... and other collaboratorsCompletedChronic HypoparathyroidismChina
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ShireCompletedA Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in HypoparathyroidismHypoparathyroidism | Chronic HypoparathyroidismUnited States
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Hospital Italiano de Buenos AiresUnknownTransient HypoparathyroidismArgentina
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Riphah International UniversityCompletedPost-Thyroidectomy HypoparathyroidismPakistan
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Institute of Biophysics and Cell Engineering of...Belarusian State Medical UniversityNot yet recruitingPostoperative Hypoparathyroidism
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Odense University HospitalActive, not recruitingHypoparathyroidism PostproceduralDenmark
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ShireWithdrawnChronic HypoparathyroidismJapan
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Nantes University HospitalFondation SantéDige; Association Francophone de Chirurgie Endocrinienne (AFCE)RecruitingHypoparathyroidism Postprocedural | ThyroidectomyFrance
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Amolyt PharmaActive, not recruitingEndocrine System Diseases | Parathyroid Diseases | Chronic HypoparathyroidismUnited States, United Kingdom, Spain, Italy, Netherlands, Denmark, Hungary, Portugal, Germany, France, Canada, Poland
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Amolyt PharmaCompletedChronic HypoparathyroidismHungary, Netherlands
Clinical Trials on PTH
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Ascendis Pharma A/SActive, not recruitingEndocrine System Diseases | Parathyroid Diseases | HypoparathyroidismUnited States, Canada, Denmark, Germany, Italy, Norway
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Nantes University HospitalCompleted
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Hospices Civils de LyonNot yet recruitingHyperparathyroidism, Primary | Hyperparathyroidism, SecondaryFrance
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John P. BilezikianShire; NPS PharmaUnknownHypoparathyroidismUnited States
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Visen Pharmaceuticals (Shanghai) Co., Ltd.RecruitingEndocrine System Diseases | Parathyroid Diseases | Hypoparathyroidism | Parathyroid Hormone DeficiencyChina
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Ascendis Pharma Bone Diseases A/SActive, not recruitingEndocrine System Diseases | Parathyroid Diseases | HypoparathyroidismUnited States, Canada, Norway, Denmark, Germany, Hungary, Italy
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ShireCompleted
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Ascendis Pharma Bone Diseases A/SClinigen Healthcare LtdAvailable
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Fujian Medical UniversityCompletedThyroid Cancer | Hypoparathyroidism | Optical ImagingChina
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Unigene Laboratories Inc.GlaxoSmithKlineCompletedPostmenopausal OsteoporosisDenmark, Estonia