- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066183
Studying Phosphorus Metabolism
Studies in Phosphorus Metabolism
Phosphorus and phosphate irons play critical roles in bone structure and essential cellular functions.
The purpose of this study is to learn more about the factors and hormones that regulate phosphorus in the body by collecting blood and urine samples from patients with disorders of phosphate control.
Both children and adults will be enrolled in this study. Researchers will collect blood and urine samples from participants on multiple occasions (2 to 6 times). Some blood specimens will be taken after an overnight fast and participants may be asked to collect all their urine during a 24-hour period. Researchers will analyze these blood and urine samples to better understanding how the body handles phosphorus.
Study Overview
Status
Conditions
Detailed Description
Phosphorus and phosphate ions play an important role in cellular metabolism as well as bone structure. Scientific evidence suggests that, in addition to Vitamin D and PTH systems, novel factors, such as Fibroblast Growth Factor 23 (FGF-23) and Matrix extracellular phosphoglycoprotein (MEPE), may play an important role in phosphorus regulation. These factors have been best studied in rare genetic and acquired phosphate wasting disorders such as tumor induced osteomalacia (TIO), X linked hypophosphatemia (XLH) and autosomal dominant hypophosphatemic rickets (ADHR). Patients with other abnormal phosphate regulating states such as hyperparathyroidism and hypoparathyroidism, pseudohypoparathyroidism etc. undergoing phosphorus-altering interventions may provide important insight into the role of these hormones.
We are proposing an observational study with collection of blood and urine samples to study both established (e.g. mineral ions, bone markers, PTH-Vit D system, TMP-GFR) and novel (e.g. FGF-23 and MEPE) constituents of the phosphorus metabolism pathway. Patients with abnormal phosphorus regulating states will be enrolled and we will study the natural history of their disease and the effects of specific interventions that are likely to change phosphorus balance.
The outcome will potentially aid understanding of this new field of mineral regulating hormones and generate both interest and research in phosphorus metabolism. It is hoped that this will also encourage clinical trials in treatment of phosphate wasting disorders.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Dental and Craniofacial Research (NIDCR)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Patients of any age, gender or ethnicity who will help fulfill the objectives laid out in Section II.
We propose to study patients primarily enrolled in other clinical center protocol(s). They will continue to receive treatment/ interventions per the original protocols.
EXCLUSION CRITERIA:
Patients with significant cognitive impairment who are unable to give informed consent or patients having other significant mineral disturbances that could confound the parameters being studied will be excluded.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Murer H, Forster I, Hernando N, Lambert G, Traebert M, Biber J. Posttranscriptional regulation of the proximal tubule NaPi-II transporter in response to PTH and dietary P(i). Am J Physiol. 1999 Nov;277(5):F676-84. doi: 10.1152/ajprenal.1999.277.5.F676.
- Cai Q, Hodgson SF, Kao PC, Lennon VA, Klee GG, Zinsmiester AR, Kumar R. Brief report: inhibition of renal phosphate transport by a tumor product in a patient with oncogenic osteomalacia. N Engl J Med. 1994 Jun 9;330(23):1645-9. doi: 10.1056/NEJM199406093302304. No abstract available.
- Jonsson KB, Mannstadt M, Miyauchi A, Yang IM, Stein G, Ljunggren O, Juppner H. Extracts from tumors causing oncogenic osteomalacia inhibit phosphate uptake in opossum kidney cells. J Endocrinol. 2001 Jun;169(3):613-20. doi: 10.1677/joe.0.1690613.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 030254
- 03-D-0254
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Phosphorus Metabolism
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Carmel Medical CenterUnknownDisorders of Phosphorus and Calcium Metabolism
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Kyowa Kirin Korea Co., Ltd.RecruitingHyperphosphatemiaKorea, Republic of
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Kyowa Kirin Co., Ltd.CompletedHyperphosphatemiaJapan
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Kyowa Kirin Co., Ltd.CompletedHyperphosphatemiaJapan
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BayerCompleted
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Washington University School of MedicineCompletedHyperphosphatemiaUnited States
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Grand Life Science (Liaoning) Co., Ltd.The First Hospital of Jilin UniversityRecruiting
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Kyowa Kirin Co., Ltd.Completed
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Kyowa Kirin Co., Ltd.CompletedHyperphosphatemiaJapan