Trial · Interventional

CompletedNot applicableResults postedRegistry data

Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

Short name 1hydroxylase

NCTNCT00754442Other idH-28679Other idH-28679

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 20 participants (actual)
Sponsor: University of Maryland, Baltimore · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Feb 2007
Primary completion: Aug 2008
Completion: Aug 2008
First posted: 18 Sept 2008 (estimated)
Last update posted: 1 Apr 2022
Conditions: Secondary Hyperparathyroidism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200720082009

N/A
1hydroxylase
NCT00754442
Feb 2007 to Aug 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TeriparatideDrug

Arms2

Active comparator
teriparatide control
control subject
Experimental
Teriparatide Patient
Patient with secondary hyperparathyroidism

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
1,25-D was measured at baseline, 4 and 8 hours after PTH infusion

Secondary outcomes(1)

The Number of Patients With Mutations in CYP27B1
Time frame · blood samples taken at baseline and sequenced over several days
Registry 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline, 4 and 8 hours after start of infusion

The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours

Group	Value (pg/ml)	Spread
Group 1	40.6	5.6
Controls	46.2	3.7

Secondary and other outcome results(1)

Secondary outcomeNumber· blood samples taken at baseline and sequenced over several days

The Number of Patients With Mutations in CYP27B1

Group	Value (participants)	Spread
Patients	0	5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Controlscontrols with normal PTH	–	0 / 11	1 / 11
Patient Grouppatients with secondary hyperparathyroidism	–	0 / 9	1 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultStreeten 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. PMID 23186957

Eligibility

Who could join, as posted.

Sex: Female
Age: from 40 Years up to 59 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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