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

Phase 3 Completed 33 enrolled Yale University National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2007-01
Primary completion: 2012-08
Completion: 2012-08

Outcome

Met primary endpoint

paper PTH area under the curve decreased 17% with paricalcitol, differing (P = .007) from the 20% increase with placebo. PMID 25029424 ↗

Publications

Background Brown AJ, Dusso AS, Slatopolsky E. Vitamin D analogues for secondary hyperparathyroidism. Nephrol Dial Transplant. 2002;17 Suppl 10:10-9. doi: 10.1093/ndt/17.suppl_10.10.
Background McElduff A, Posen S. Parathyroid hormone sensitivity in familial X-linked hypophosphatemic rickets. J Clin Endocrinol Metab. 1989 Aug;69(2):386-9. doi: 10.1210/jcem-69-2-386.
Carpenter TO, Olear EA, Zhang JH, Ellis BK, Simpson CA, Cheng D, Gundberg CM, Insogna KL. Effect of paricalcitol on circulating parathyroid hormone in X-linked hypophosphatemia: a randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2014 Sep;99(9):3103-11. doi: 10.1210/jc.2014-2017. Epub 2014 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paricalcitol	Other / unclassified	—	—