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NCT00356512
Physiologic Regulation of FGF-23
trial in Hypoparathyroidism in 20 participants. Completed.
2 September 2009
Quick facts
| Lead sponsor | National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 19 July 2006 |
| Primary completion | 2 September 2009 |
| Sites | 1 location across United States |
Conditions studied
- Hypoparathyroidism — all drugs for Hypoparathyroidism →
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Who can join
18 and older, any sex, with Hypoparathyroidism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will explore the regulation of fibroblast growth factor-23 (FGF-23). It is a hormone recently identified as a regulator of the blood levels of phosphorus and vitamin D, both of which are essential for overall health and especially important for bone health. The parathyroid hormone (PTH) regulates phosphorus and calcium, but people with hypoparathyroidism or pseudohypoparathyroidism do not have sufficient PTH action. There are genetic diseases that influence FGF-23, causing abnormal metabolism of phosphorus and vitamin D, thus affecting the bones. Also, there are rare tumors that may cause overproduction of FGF-23 causing debilitating bone disease. Patients ages 18 and older who have low PTH levels, or are resistant to PTH action, and take calcitriol and calcium supplements, who are not pregnant, and who do not have kidney disorders may be eligible for this study. During the 4-day study, patients will be provided with a controlled diet that has a lower than usual phosphorus content. On day 1, patients will be admitted to the NIH Clinic Center and undergo blood and urine tests to measure calcium, phosphorus, vitamin D, and FGF-23. They will continue with their regular medicine for hypoparathyroidism. On that day and throughout the study, patients will fast from 10:00 p.m. to 8:00 a.m. the following day. On day 2, patients will continue fasting until 4:00 p.m. A tube will be placed in the vein of each arm: one for drawing blood and the other for infusing calcium. Just one intravenous (IV) line will be used on the other days. Patients will receive calcium chloride for 8 hours, at a dose carefully monitored by a machine. The purpose is to bring the blood calcium level to the high normal range or just above. Blood and urine samples will be collected periodically, to check for effects of calcium chloride on FGF-23 and PTH. On days 3 and 4, patients will not take calcitriol and calcium but will receive injections of PTH, under the skin, two times each day. On day 3, blood and urine samples will be again be collected for analysis. On day 4, patients will receive one dose of calcitriol by IV. The total amount of blood drawn during this study will be about 5 ounces. ...
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00356512
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Hypoparathyroidism
Currently open trials in the same condition.
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- NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
- NCT07530705 — Efficacy and Safety of Subcutaneous Injection of XH-02 in the Treatment of Adult Hypoparathyroidism · Phase 1, PHASE2 · recruiting
- NCT07197450 — Efficacy and Safety of XH02 for the Treatment of Hypoparathyroidism · EARLY_PHASE1 · recruiting
- NCT06645899 — Institution of an Italian Multicenter Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism · recruiting
Other National Institute of Dental and Craniofacial Research (NIDCR) trials
Trials by the same sponsor.
- NCT07281456 — Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease · Phase 2 · recruiting
- NCT05735015 — PTH-independent Effects of Encaleret · Phase 2 · completed
- NCT05509595 — Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia · Phase 2 · completed
- NCT05419050 — Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia · Phase 2 · completed
- NCT04496960 — Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00356512 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Dental and Craniofacial Research (NIDCR)
- Last refreshed: 2 July 2017
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