N/A Completed N=20 Diagnostic

Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

Source: ClinicalTrials.gov NCT00754442 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcomePrimary: The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours — 40.6; 46.2; 39.8; 58.8 pg/ml — p=0.1

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours	40.6; 46.2; 39.8; 58.8; 56.4; 105	0.1
SECONDARY The Number of Patients With Mutations in CYP27B1	—	—

Eligibility Criteria

Inclusion Criteria

Caucasian female
Age 40-59 years
Serum creatinine 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00754442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.