Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

NCT00754442 | Completed Results DMC

• 1 other identifier: H-28679
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Hyperparathyroidism

Keywords

hyperparathyroidism; parathyroid; vitamin D; vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 4 and 8 hours after start of infusion

Secondary Outcomes (1)

• The Number of Patients With Mutations in CYP27B1

  blood samples taken at baseline and sequenced over several days

Study Arms (2)

teriparatide control

ACTIVE COMPARATOR

control subject

Drug: Teriparatide

Teriparatide Patient

EXPERIMENTAL

Patient with secondary hyperparathyroidism

Drug: Teriparatide

Interventions

Teriparatide DRUG

Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"

Also known as: Forteo

Teriparatide Patient; teriparatide control

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine Division of Endocrinology

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 23186957 RESULT

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Hyperparathyroidism; Vitamin D Deficiency

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Elizabeth A Streeten, MD
• Organization: University of Maryland School of Medicine

estreete@medicine.umaryland.edu

410-328-6219

Study Officials

• Elizabeth A Streeten, MD

  Division of Endocrinology, University of Maryland School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: February 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 1, 2022
• Results First Posted: May 14, 2014

Record last verified: 2022-03

Locations

US (1)