Extended-Release Calcifediol Reduces Bone Turnover in SHPT

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Levels of the bone turnover markers CTX and P1NP declined over approximately 6 months of treatment patients with CKD and secondary hyperparathyroidism.
Levels of the bone turnover markers CTX and P1NP declined over approximately 6 months of treatment patients with CKD and secondary hyperparathyroidism.
The following article is part of conference coverage from the NKF 2018 Spring Clinical Meetings in Austin hosted by the National Kidney Foundation. Renal & Urology News staff will be reporting on medical studies conducted by nephrologists and other specialists who are tops in their field in chronic kidney disease, dialysis, transplantation, and more. Check back for the latest news from NKF 2018.

AUSTIN, Texas—Extended-release (ER) calcifediol provides the added benefit of reducing levels of bone turnover markers in patients with stage 3 to 4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT), and vitamin D deficiency, according to a new study presented at the National Kidney Foundation's 2018 Spring Clinical Meetings. These improvements occurred with minimal changes in serum calcium and phosphorus.

In 2 identical, double-blind trials of 429 patients randomized 2:1 to ER calcifediol (ERC) or placebo, mean levels of collagen type 1 cross-linked C-telopeptide (CTX) fell by 124 vs 15 pg/mL in diabetic patients, a team led by Stuart M. Sprague, DO, of NorthShore University Health System-University of Chicago Pritzker School of Medicine in Evanston, Illinois, reported. Among non-diabetic patients, CTX decreased by 121 pg/mL in the ERC group and increased by 116 pg/mL among placebo recipients over approximately 6 months.

Among diabetic patients, procollagen type I amino-terminal propeptide (P1NP) declined by 14 ng/mL in the ERC group and increased by 5 ng/mL in the placebo arm; among non-diabetic patients, P1NP decreased by 8 ng/mL in the ERC group and increased by 16 ng/mL in placebo recipients. All results were significant except for the decline in CTX in diabetic patients. ERC was initiated at 30 µg/d and increased, as needed, to 60 µg/day after 3 months.

Vitamin D prohormone repletion therapy minimally affected serum calcium and phosphate levels, the team added. Both calcium and phosphate increased by 0.1 mg/dL in diabetic and non-diabetic patients compared with placebo.

“This post-hoc analysis demonstrated that diabetes had no effect on the efficacy or safety of extended-release calcifediol in treating patients with SHPT and vitamin D insufficiency in stage 3 or 4 CKD," Dr Sprague told Renal & Urology News. "It also showed that extended-release calcifediol treatment improved bone turnover markers in both diabetic and non-diabetic subjects.”

The study was funded by OPKO Health, which manufactures ER calcifediol. Dr Sprague is a consultant for OPKO Health Renal Division.

See more coverage from the National Kidney Foundation Spring Clinical meeting

Reference

Sprague S, Strugnell S, Ashfaq A, and Bishop C. Extended-release calcifediol improves bone marker levels in CKD patients with diabetes. Poster presented at the National Kidney Foundation's 2018 Spring Clinical Meetings in Austin, Texas, April 10-14, 2018. Poster 174.

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