Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypophosphatemia, Familial, Hyperparathyroidism

In brief

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 adults with X-linked hypophosphatemic (XLH) rickets.

Key facts

Study ID

NCT00417612

Run by

Yale University

People needed

33

Starts

2007-01-01

Expected to finish

2012-08-01

Last updated by the study team

2020-03-17

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.