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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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 adults with X-linked hypophosphatemic (XLH) rickets.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Ergocalciferols; Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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