Current partner codePEPTIDESDE
NCT00754442·Not applicable·INTERVENTIONAL

Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

Status

Completed

Phase

Not applicable

Enrollment

20

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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"

Timeline

From registration to results.

  1. First posted

    Sep 18, 2008

  2. Study start

    Feb 2007

  3. Primary completion

    Aug 2008

  4. Study completion

    Aug 2008

  5. Results posted

    May 14, 2014

  6. Registry updated

    Apr 1, 2022

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
59 Years
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Maryland School of Medicine Division of Endocrinology

Baltimore, Maryland, United States

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

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