Status:
COMPLETED
Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Hypophosphatemia, Familial
Hyperparathyroidism
Eligibility:
All Genders
9+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effectiveness of paricalcitol, a form of synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease symptoms in children and a...
Detailed Description
XLH rickets is a rare inherited disorder in which the bones become painfully soft and bend easily because of a phosphate deficiency. This genetic defect causes the kidneys to allow excretion of an ina...
Eligibility Criteria
Inclusion
- Diagnosis of XLH rickets
- Fasting serum calcium of 10.7 mg/dl or less
- Fasting PTH greater than 40 nleq/ml and less than 120 nleq/ml in the mid-molecule PTH assay at screening (upper limit of normal is 25 nleq/ml)
- Willing and able to participate in the trial
- Taking stable dose of standard therapy for XLH rickets for at least 2 months prior to study entry
- Concomitant therapy for XLH rickets will not be an exclusion criteria
- Parent or guardian willing to provide informed consent, if applicable
Exclusion
- Concomitant kidney failure (estimated creatinine clearance less than 60 cc/min or serum creatinine greater than 1.5 mg/dl)
- Serum 25-hydroxy vitamin D less than 20 ng/ml. Participants meeting this criterion will receive vitamin D3 supplementation for 3 months and then be rescreened.
- Unable to comply with protocol and appropriate follow-up visits
- Treatment with agents that may affect skeletal metabolism, such as glucocorticoids and anticonvulsants
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00417612
Start Date
January 1 2007
End Date
August 1 2012
Last Update
March 17 2020
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520