Calcimimetics in Hypophosphatemic Rickets

Familial Hypophosphatemic Rickets Clinical Trial

— CHR  

Official title:

Effect of Cinacalcet on the Long-term Treatment of Familial Hypophosphatemic Rickets

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00844740
• Other study ID #: 08 09-152
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2009
• Est. completion date: March 1, 2012

Study information

• Verified date: December 2020
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, large oral doses of phosphate and 1,25(OH)2D (calcitriol) are the standard treatment of patients with familial hypophosphatemic rickets (XLH). While this therapy is effective in healing the rickets, it is often limited by development of complications due to the high dose of medications required to achieve cure. Among them are the development of calcifications in the kidneys and secondary hyperparathyroidism (HPT) which in some patients may cause complications like high blood calcium level, high blood pressure and damage to the kidney. A drug to treat secondary hyperparathyroidism was just developed. In a short term study we found that it might help the treatment of XLH, by allowing the use of lower doses of the both phosphate and calcitriol. In the present study we will learn if indeed the addition of this new medicine (Cinacalcet) to the long-term treatment will allow the use of lower doses of both phosphate and calcitriol and consequently lower the risk of complications.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2012
• Est. primary completion date: March 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

Inclusion Criteria:

1. Patients with XLH

2. Age 5-21 years old

3. From the Renal and Endocrinology Clinics who have been in a stable clinical, biochemical and radiological condition for the preceding 9 months

4. Who have not received Cinacalcet before

Exclusion Criteria:

1. Treatment with growth hormone

2. Inability to swallow pills.

3. An orthopedic surgery or braces in the past 9 months, or scheduled within 9 months of start.

4. Pregnancy

5. History of seizure disorder

6. Abnormal liver functions (which may change the drug's AUC)

Related Conditions & MeSH terms

• Familial Hypophosphatemic Rickets
• Rickets

Intervention

Drug:
• Cinacalcet
Stable patients with XLH already treated with Phosphate and calcitriol will add Cinacalcet to their treatment regimen. Sequential monitoring of blood nand urine biochemical variables will follow, based on which adjustments to the doses of the 3 medications will be done.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	doses of phosphate and calcitriol required to sustain goals of blood and urine chemistries		9 months