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Calcitonin for Treating X-linked Hypophosphatemia

NCT01652573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-05-31

Study results available
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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.

Conditions

  • Hypophosphatemic Rickets, X Linked Dominant

Interventions

DRUG

nasal salmon calcitonin

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

DRUG

Saline Nasal Spray Placebo

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Karl L Insogna, MD · Profossor of Medicine, Yale School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01652573 on ClinicalTrials.gov