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Calcimimetics in Hypophosphatemic Rickets

Information source: Children's Mercy Hospital Kansas City
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Familial Hypophosphatemic Rickets

Intervention: Cinacalcet (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Children's Mercy Hospital Kansas City

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.

Clinical Details

Official title: Effect of Cinacalcet on the Long-Term Treatment of Familial Hypophosphatemic Rickets

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: doses of phosphate and calcitriol required to sustain goals of blood and urine chemistries

Eligibility

Minimum age: 5 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Children's Mercy Hospital, Kansas City, Missouri 64108, United States
Additional Information

Starting date: February 2009
Last updated: February 13, 2009

Page last updated: August 23, 2015

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