CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
nasal salmon calcitonin +1 moredrug
Likely dose
nasal salmon calcitonin 400 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01652573
NCT01652573N/ACompleted
CompareCT.gov

Calcitonin for Treating X-linked Hypophosphatemia

Yale University·interventional·Posted Jul 30, 2012·Updated May 31, 2017

In Brief

A clinical study evaluating nasal salmon calcitonin and Saline Nasal Spray Placebo for Hypophosphatemic Rickets, X Linked Dominant. Completed, enrolled 21 participants across 1 site.

Detailed Summary

X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone call FGF23, which makes the body waste phosphate. This study is designed to determine if nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and reduce phosphate wasting in patients with XLH. In this study the investigators will: 1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels of FGF23 in patients with XLH. 2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH. 3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D and calcium absorption from the intestine. 4. Make sure that nasal calcitonin is safe and well tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatemic Rickets, X Linked Dominant
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2012
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.9 years ago

Interventions

nasal salmon calcitonindrug

400 IU daily in two sprays (one to each nares)

Saline Nasal Spray Placebodrug