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Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism (1hydroxylase)

Primary Purpose

Secondary Hyperparathyroidism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teriparatide
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Secondary Hyperparathyroidism focused on measuring hyperparathyroidism, parathyroid, vitamin D, vitamin D deficiency

Eligibility Criteria

40 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Caucasian female
  • Age 40-59 years
  • Serum creatinine < 1.3 and estimated glomerular filtration rate (GRF) > 60
  • Serum calcium in the normal range (for U Md lab 8.6-10 mg/dl)
  • Parathyroid hormone in the normal range (for U Md lab 12-54 pg/ml)
  • Normal 25-hydroxyvitamin D level (30 ng/ml or higher)
  • For women of childbearing age, non-pregnant (based on negative urine pregnancy test on the morning of the teriparatide infusion)

Exclusion Criteria:

  • Non-caucasian
  • Age under 40 and over 59 years
  • Male
  • Serum creatinine over 1.3 or estimated glomerular filtration rate (GFR) < 60
  • Abnormal serum calcium (for U Md lab, below 8.6 or above 10 mg/dl)
  • Abnormal parathyroid hormone (for U Md lab, above 65 or below 12 pg/ml)
  • For women of childbearing age, non-pregnant (based on urine pregnancy test on the morning of the teriparatide infusion)
  • History of bone radiation
  • History of Paget disease of bone
  • History of bone malignancy or metastases
  • History of allergy or sensitivity to Forteo

Sites / Locations

  • University of Maryland School of Medicine Division of Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

teriparatide control

Teriparatide Patient

Arm Description

control subject

Patient with secondary hyperparathyroidism

Outcomes

Primary Outcome Measures

The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours
1,25-D was measured at baseline, 4 and 8 hours after PTH infusion

Secondary Outcome Measures

The Number of Patients With Mutations in CYP27B1
CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data

Full Information

First Posted
September 17, 2008
Last Updated
March 30, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT00754442
Brief Title
Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism
Acronym
1hydroxylase
Official Title
Clinical and Molecular Characterization of Suspected Partial 25-hydroxyvitamin D-1-alpha-hydroxylase Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney function.
Detailed Description
Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney diseases. We have identified a small group of patients who appear to have reduced ability of the kidneys to activate vitamin D, even though they are young and do not have chronic kidney disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that controls this activation is also being studied (by a simple blood test) to look for abnormalities. We are now actively recruiting healthy controls for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
hyperparathyroidism, parathyroid, vitamin D, vitamin D deficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
teriparatide control
Arm Type
Active Comparator
Arm Description
control subject
Arm Title
Teriparatide Patient
Arm Type
Experimental
Arm Description
Patient with secondary hyperparathyroidism
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"
Primary Outcome Measure Information:
Title
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours
Description
1,25-D was measured at baseline, 4 and 8 hours after PTH infusion
Time Frame
baseline, 4 and 8 hours after start of infusion
Secondary Outcome Measure Information:
Title
The Number of Patients With Mutations in CYP27B1
Description
CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data
Time Frame
blood samples taken at baseline and sequenced over several days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Caucasian female Age 40-59 years Serum creatinine < 1.3 and estimated glomerular filtration rate (GRF) > 60 Serum calcium in the normal range (for U Md lab 8.6-10 mg/dl) Parathyroid hormone in the normal range (for U Md lab 12-54 pg/ml) Normal 25-hydroxyvitamin D level (30 ng/ml or higher) For women of childbearing age, non-pregnant (based on negative urine pregnancy test on the morning of the teriparatide infusion) Exclusion Criteria: Non-caucasian Age under 40 and over 59 years Male Serum creatinine over 1.3 or estimated glomerular filtration rate (GFR) < 60 Abnormal serum calcium (for U Md lab, below 8.6 or above 10 mg/dl) Abnormal parathyroid hormone (for U Md lab, above 65 or below 12 pg/ml) For women of childbearing age, non-pregnant (based on urine pregnancy test on the morning of the teriparatide infusion) History of bone radiation History of Paget disease of bone History of bone malignancy or metastases History of allergy or sensitivity to Forteo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Streeten, MD
Organizational Affiliation
Division of Endocrinology, University of Maryland School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine Division of Endocrinology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23186957
Citation
Streeten EA, Rogstad AS, Flammer KM, Zarbalian K, Ryan K, Horwitz M, Holick MF, Shelton J. Reduced parathyroid hormone-stimulated 1,25-dihydroxyvitamin d production in vitamin d sufficient postmenoposual women with low bone mass and idiopathic secondary hyperparathyroidism. Endocr Pract. 2013 Jan-Feb;19(1):91-9. doi: 10.4158/EP12151.OR.
Results Reference
result

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Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

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