Novel, selective vitamin D analog suppresses parathyroid hormone in uremic animals and postmenopausal women

Am J Nephrol. 2014;39(6):476-83. doi: 10.1159/000362846. Epub 2014 May 17.

Abstract

Background: The use of 1α-hydroxylated vitamin D therapy to control secondary hyperparathyroidism in renal failure patients has been a success story, culminating with the demonstration of increased life expectancy in patients treated with these compounds. However, hypercalcemic episodes have been a recurrent problem with these therapies and have resulted in the added use of calcium mimetics. Clearly there is good reason to search for improved vitamin D therapy. In our inventory of vitamin D compounds, 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D3 (2MD) surfaced as a potential candidate. This was based on its preferential localization in the parathyroid gland and a clear suppression of serum parathyroid hormone (PTH) levels without a change in serum calcium in a clinical trial in postmenopausal women.

Methods: 2MD has now been tested in the rat 5/6-nephrectomy model of renal failure, and in postmenopausal women to determine if it can suppress serum PTH at doses that do not elevate serum calcium and serum phosphorus concentrations.

Results: Daily oral treatment of uremic rats on 2.5 ng/bw/day of 2MD dramatically suppressed PTH without a change in serum calcium or serum phosphorus. Further, PTH was suppressed in postmenopausal women after only 3 daily oral doses of 2MD that continued for 4 weeks with no change in serum calcium or serum phosphorus.

Conclusion: These results coupled with a pharmacokinetic half-life of ~24 h suggest that 2MD given either daily or at the time of dialysis may be a superior therapy for secondary hyperparathyroidism in chronic renal failure patients.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Bone Density Conservation Agents / metabolism
  • Bone Density Conservation Agents / pharmacology*
  • Bone Density Conservation Agents / therapeutic use
  • Calcitriol / analogs & derivatives*
  • Calcitriol / metabolism
  • Calcitriol / pharmacology
  • Calcitriol / therapeutic use
  • Calcium / blood
  • Chromatography, High Pressure Liquid
  • Double-Blind Method
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / drug therapy
  • Hyperparathyroidism, Secondary / etiology
  • Male
  • Parathyroid Glands / metabolism
  • Parathyroid Hormone / blood*
  • Phosphorus / blood
  • Postmenopause / blood
  • Postmenopause / drug effects*
  • Rats
  • Renal Insufficiency, Chronic / complications
  • Uremia

Substances

  • 2-methylene-1,25-dihydroxy-19-norvitamin D3
  • Bone Density Conservation Agents
  • Parathyroid Hormone
  • Phosphorus
  • Calcitriol
  • Calcium