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Osteomalacia clinical trials

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NCT ID: NCT03736564 Active, not recruiting - Osteomalacia Clinical Trials

Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia

Start date: January 31, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The researchers are trying to evaluate a newer imaging technique (Ga-DOTATATE PET/CT) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.

NCT ID: NCT03510455 Terminated - Clinical trials for Tumor-Induced Osteomalacia

BGJ398 for the Treatment of Tumor-Induced Osteomalacia

Start date: February 27, 2019
Phase: Phase 2
Study type: Interventional

Background: People with tumor-induced osteomalacia (TIO) have small tumors that may cause low blood phosphorus, weak muscles, bone pain, and broken bones. The tumors may be so small they are hard to find or impossible to remove. Researchers want to test a drug that may help treat TIO. Objective: To see how the drug BGJ398 affects people with tumor-induced osteomalacia. Eligibility: People ages 18-85 who are in NIH protocol 01-D-0184 and have TIO that cannot be found or easily removed Design: At every study visit, participants will have: - Medical history - Physical exam - Blood and urine tests - Questions about their health and fatigue At the screening visit, participants will also have a heart and eye tests. They may have other tests to find their tumor. The baseline visit will be a 1-week stay in the clinic. Participants will have the regular study tests, plus: - Their first dose of the study drug capsules - Blood and urine collected every 2-4 hours for 24 hours. A thin plastic tube will be inserted in a vein to collect blood. - Heart and kidney ultrasounds - Activities that test strength - 6-minute walk test Participants will take the study drug for six 1-month cycles. In each cycle, participants will: - Take the study drug every day for 4 weeks. - Have 1 visit. Participants will collect their urine for 24 hours and have their blood drawn. Participants will have the regular study tests and repeat some baseline tests. - Have blood and urine tests at their local lab. Participants will have 1 visit at the end of the last cycle and another 3 months later....

NCT ID: NCT03233126 Completed - Clinical trials for X-linked Hypophosphatemic Rickets/Osteomalacia

A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia

Start date: July 6, 2017
Phase: Phase 3
Study type: Interventional

Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH). After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing study drug, at the approved dose and dosing regimen in subjects who continue treatment

NCT ID: NCT02814591 Active, not recruiting - Osteoarthritis Clinical Trials

Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy

Start date: October 2011
Phase:
Study type: Observational [Patient Registry]

In this study spatially offset Raman spectroscopy (SORS), which allows the collection of Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.

NCT ID: NCT02722798 Completed - Clinical trials for Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome

A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome

Start date: April 2016
Phase: Phase 2
Study type: Interventional

Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 after its 144-week once every 4 weeks (Q4W) repeated SC administration to Japanese and Korean patients with TIO or ENS by a multicenter, open-label, intraindividual dose adjustment study. After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continue treatment after the marketing approval of KRN23 in Japan.

NCT ID: NCT02548520 Completed - Osteoporosis Clinical Trials

Maternal and Infant Vitamin Status During the First Nine Months of Infant Life

Start date: October 2008
Phase: N/A
Study type: Observational

In this study the investigators wanted to assess vitamin D status and possible consequences of low plasma 25-hydroxyvitamin D levels in a population of healthy mothers and their infants, in the community of Aarhus, Denmark.

NCT ID: NCT02537431 Completed - Clinical trials for X-linked Hypophosphatemia

Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

Start date: December 23, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).

NCT ID: NCT02331966 Recruiting - Clinical trials for Tumor Induced Oncogenic Osteomalacia

Molecular Pathways Involved in the Pathogenesis and Behavior of Mesenchymal Phosphaturic Tumors Causing Oncogenic Osteomalacia

Start date: September 2014
Phase: N/A
Study type: Observational

The tumors that cause oncogenic osteomalacia (TIO) express and release in the circulation phosphaturic factors such as fibroblast growth factor-23 (FGF-23) that decrease renal phosphate absorption through acting in the proximal renal tubule and decreasing Type 2a and 2c sodium-phosphate co-transporter. They typically follow a benign clinical course and even in the rare malignant cases, local recurrence occurs in less than 5% and distant metastasis are very uncommon. In this study we aim to investigate the role of other molecular pathways such as ERK1, ERK2, mTOR, EGFR, MEK1, MEK2, VEGFR3, AKT1, AKT2, IGFR-1, IGFR-2, PDGFRA, PDGFRB, cMET, FGFR2, apart from FGF23, KLOTHO and PHEX, in the behavior of histopathologically benign mesenchymal phosphaturic tumors.

NCT ID: NCT02304367 Completed - Clinical trials for Tumor Induced Osteomalacia (TIO)

Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)

Start date: March 24, 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the effect of burosumab treatment on: - Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia - Improvement in TIO/ENS-associated osteomalacia as determined by osteoid thickness (O.Th), osteoid surface/bone surface (OS/BS), osteoid volume/bone volume (OV/BV) and mineralization lag time (MLt).

NCT ID: NCT02252679 Completed - Osteoporosis Clinical Trials

Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders

eCaSIS
Start date: October 2014
Phase:
Study type: Observational

The purpose of this study is to determine whether mass spectrometry analysis of stable (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of bone and calcium disorders.