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Calcimimetics in Hypophosphatemic Rickets (CHR)

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ClinicalTrials.gov Identifier: NCT00844740
Recruitment Status : Unknown
Verified February 2009 by Children's Mercy Hospital Kansas City.
Recruitment status was:  Enrolling by invitation
First Posted : February 16, 2009
Last Update Posted : February 16, 2009
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

February 12, 2009
February 16, 2009
February 16, 2009
February 2009
June 2010   (Final data collection date for primary outcome measure)
doses of phosphate and calcitriol required to sustain goals of blood and urine chemistries [ Time Frame: 9 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Calcimimetics in Hypophosphatemic Rickets
Effect of Cinacalcet on the Long-Term Treatment of Familial Hypophosphatemic Rickets
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Familial Hypophosphatemic Rickets
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.
Other Name: Sensipar
Experimental: Cinacalcet
Stable patients with XLH already treated with Phosphate and calcitriol will add Cinacalcet to their treatment regimen. Sequential monitoring of blood and urine biochemical variables will follow, based on which adjustments to the doses of the 3 medications will be done.
Intervention: Drug: Cinacalcet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
Same as current
Not Provided
June 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
5 Years to 21 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00844740
08 09-152
Yes
Not Provided
Not Provided
Uri S. Alon, MD, Children's Mercy Hospital
Children's Mercy Hospital Kansas City
Not Provided
Not Provided
Children's Mercy Hospital Kansas City
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP