NCT00473265

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 16, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

6.7 years

First QC Date

May 14, 2007

Results QC Date

October 23, 2013

Last Update Submit

July 14, 2015

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Requirements for Calcium Supplementation

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

    2 years

Secondary Outcomes (5)

  • Percent Change in BMD From Baseline to 24 Months by DXA

    baseline versus 24 months

  • Trabecular Width

    baseline versus two years

  • Trabecular Number

    baseline versus two years

  • Cortical Porosity

    baseline versus two years

  • Mineralizing Surface

    baseline versus one year

Study Arms (1)

PTH(1-84)

EXPERIMENTAL

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

Drug: PTH

Interventions

PTHDRUG
Also known as: teriparatide, Preotact, PTH1-84, rhPTH, Natpara
PTH(1-84)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypoparathyroidism

You may not qualify if:

  • Bisphosphonate use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • Rubin MR, Zhou H, Cusano NE, Majeed R, Omeragic B, Gomez M, Nickolas TL, Dempster DW, Bilezikian JP. The Effects of Long-term Administration of rhPTH(1-84) in Hypoparathyroidism by Bone Histomorphometry. J Bone Miner Res. 2018 Nov;33(11):1931-1939. doi: 10.1002/jbmr.3543. Epub 2018 Aug 16.

    PMID: 29972871DERIVED

MeSH Terms

Conditions

Hypoparathyroidism

Interventions

TeriparatideParathyroid Hormone

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

Only 16 subjects received a bone biopsy, which is why many of the measurements were only analyzed in 16 subjects. In total, data was only analyzed for the first 30 subjects analyzed for data.

Results Point of Contact

Title
John P. Bilezikian MD
Organization
Columbia University Medical Center
jpb2@columbia.edu
212-305-2663

Study Officials

  • John P Bilezikian, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dorothy L. and Daniel H. Silberberg Professor of Medicine and Pharmacology

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

May 1, 2004

Primary Completion

January 1, 2011

Study Completion

June 1, 2014

Last Updated

July 16, 2015

Results First Posted

July 16, 2015

Record last verified: 2015-07

Locations

US(1)