|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00195936 |
|
Date of registration:
|
13/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic Rickets
|
|
Scientific title:
|
Effect of Calcimimetic (Cinacalcet) on Phosphate-Induced Hyperparathyroidism in Children With Hypophosphatemic Rickets |
|
Date of first enrolment:
|
June 2005 |
|
Target sample size:
|
|
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00195936 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Rachel Levy-Olomucki, MD |
|
Address:
|
|
|
Telephone:
|
816-234-3010 |
|
Email:
|
rlevy@cmh.edu |
|
Affiliation:
|
|
|
|
Name:
|
Rachel Levy-Olomucki, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Section of Pediatric Nephrology, Children's Mercy Hospitals and Clinics |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Established patients with XLH
- Age 5 years old and above
- Normal serum calcium and creatinine concentrations
Exclusion Criteria:
- Patients with hypersensitivity to any component(s) of cinacalcet
- Hypocalcaemia
- Elevated serum creatinine
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypophosphatemic Rickets, X-Linked Dominant
|
|
Intervention(s)
|
|
Drug: Cinacalcet
|
|
Primary Outcome(s)
|
|
The primary outcome will be the effect of cinacalcet on serum PTH.
[Time Frame: PTH will be measured at time 0 and then every 30 minutes for 4 hours after receiving the medications]
|
|
Secondary Outcome(s)
|
|
Secondary outcome will be the effect of the calcimimetic on mineral homeostasis; ionized calcium, total calcium, and phosphate will be measured.
[Time Frame: At time 0 and then every 30 minutes for 4 hours after receiving the medications]
|
|
Secondary ID(s)
|
|
05 02-027
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|