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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Bone Properties in Hypoparathyroidism: Effects of PTH

NCTNCT00473265 (opens ClinicalTrials.gov in a new tab)Other idAAAA5457Other idR01DK069350
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
68 participants (actual)
Sponsor
John P. Bilezikian · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2004
Primary completion
Jan 2011
Completion
Jun 2014
First posted
15 May 2007 (estimated)
Last update posted
16 Jul 2015 (estimated)
Conditions
Hypoparathyroidism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420062008201020122014
  1. Ph 2/3

    Bone Properties in Hypoparathyroidism: Effects of PTH

    NCT00473265

    May 2004 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PTHDrug

Arms1

  • Experimental

    PTH(1-84)

    100mcg of PTH1-84 every other day, every day, or every three days

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Requirements for Calcium Supplementation

    Time frame · 2 years

    Registry description

    Serum and urinary calcium levels maintained by change in requirements for calcium supplementation

Secondary outcomes(5)

  1. Percent Change in BMD From Baseline to 24 Months by DXA

    Time frame · baseline versus 24 months

    Registry description

    Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).

  2. Trabecular Width

    Time frame · baseline versus two years

    Registry description

    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.

  3. Trabecular Number

    Time frame · baseline versus two years

    Registry description

    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.

  4. Cortical Porosity

    Time frame · baseline versus two years

    Registry description

    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.

  5. Mineralizing Surface

    Time frame · baseline versus one year

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 2 years

Requirements for Calcium Supplementation

GroupValue (grams per day of calcium supplementation)Spread
PTH1-843.032.32
Secondary and other outcome results(5)
Secondary outcomeMean· baseline versus 24 months

Percent Change in BMD From Baseline to 24 Months by DXA

GroupValue (percentage of change to BMD)Spread
PTH1-842.94
Secondary outcomeMean· baseline versus two years

Trabecular Width

GroupValue (micrometers)Spread
PTH1-8414434
Secondary outcomeMean· baseline versus two years

Trabecular Number

GroupValue (mm^-1)Spread
PTH1-841.740.34
Secondary outcomeMean· baseline versus two years

Cortical Porosity

GroupValue (percentage of porosity)Spread
PTH1-847.43.2
Secondary outcomeMean· baseline versus one year

Mineralizing Surface

GroupValue (percentage of surface)Spread
PTH1-840.70.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PTH1-84participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement–15 / 6868 / 68

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2018

The Effects of Long-term Administration of rhPTH(1-84) in Hypoparathyroidism by Bone Histomorphometry.

Rubin et al. 2018Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 33

PMID 29972871PMC6546298DOI 10.1002/jbmr.3543PUB-29972871

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Hypoparathyroidism Exclusion Criteria: * Bisphosphonate use

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