N/A
N=20
Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00754442 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: 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 pg/ml — p=0.1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Teriparatide (Drug)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Aug 2008
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 |
— | — |
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.
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
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.