CompletedNot Applicable

Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

United States20 participantsStarted 2007-02

Plain-language 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.

Who can participate

Age range

40 Years – 59 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline, 4 and 8 hours after start of infusion

Trial details

NCT IDNCT00754442

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-08

Results submitted2013-01-17

View on ClinicalTrials.gov More Secondary Hyperparathyroidism trials