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

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ClinicalTrials.gov Identifier: NCT00754442
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : May 14, 2014
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Streeten, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE September 17, 2008
First Posted Date  ICMJE September 18, 2008
Results First Submitted Date  ICMJE January 17, 2013
Results First Posted Date  ICMJE May 14, 2014
Last Update Posted Date September 4, 2019
Study Start Date  ICMJE February 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours [ Time Frame: baseline, 4 and 8 hours after start of infusion ]
1,25-D was measured at baseline, 4 and 8 hours after PTH infusion
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
The level of activated Vitamin D (1,25-dihydroxyvitamin D) after parathyroid hormone infusion [ Time Frame: 4 and 8 hours after start of infusion ]
Change History Complete list of historical versions of study NCT00754442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
The Number of Patients With Mutations in CYP27B1 [ Time Frame: blood samples taken at baseline and sequenced over several days ]
CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
Abnormalities in the gene for the 1-hydroxylase enzyme [ Time Frame: baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism
Official Title  ICMJE Clinical and Molecular Characterization of Suspected Partial 25-hydroxyvitamin D-1-alpha-hydroxylase Deficiency
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Secondary Hyperparathyroidism
Intervention  ICMJE Drug: Teriparatide
Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"
Other Name: Forteo
Study Arms  ICMJE
  • Active Comparator: teriparatide control
    control subject
    Intervention: Drug: Teriparatide
  • Experimental: Teriparatide Patient
    Patient with secondary hyperparathyroidism
    Intervention: Drug: Teriparatide
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2014)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2008)
16
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00754442
Other Study ID Numbers  ICMJE H-28679
H-28679 ( Other Identifier: IRB number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Streeten, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth A Streeten, MD Division of Endocrinology, University of Maryland School of Medicine
PRS Account University of Maryland, Baltimore
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP