A new active vitamin D, ED-71, increases bone mass in osteoporotic patients under vitamin D supplementation: a randomized, double-blind, placebo-controlled clinical trial

J Clin Endocrinol Metab. 2005 Sep;90(9):5031-6. doi: 10.1210/jc.2004-2552. Epub 2005 Jun 21.

Abstract

Context: ED-71 has been shown to increase lumbar bone mineral density (BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED-71 on BMD.

Objective: Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D supplementation.

Design, setting, and patients: We conducted a randomized, double-blind, placebo-controlled clinical trial of 219 osteoporotic patients (49-87 yr of age).

Interventions: Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 microg/d ED-71 for 12 months. All the subjects received 200 or 400 IU/d vitamin D(3).

Main outcome measures: We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.

Results: Lumbar BMD increased with ED-71 treatment for 12 months (2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 microg ED-71, respectively). Total hip BMD also increased with 0.75 and 1.0 microg ED-71 (-0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 microg ED-71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 microg ED-71 treatment. Transient hypercalcemia over 2.6 mmol/liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 microg ED-71 groups, respectively, but none of them developed sustained hypercalcemia.

Conclusions: These results demonstrate that ED-71 treatment at around 0.75 microg/d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Absorptiometry, Photon
  • Aged
  • Aged, 80 and over
  • Biomarkers / blood
  • Biomarkers / urine
  • Bone Density / drug effects*
  • Bone Remodeling
  • Calcitriol / administration & dosage
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Calcitriol / blood
  • Calcitriol / therapeutic use
  • Calcium / metabolism
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Hip Joint / diagnostic imaging
  • Hip Joint / metabolism
  • Hormones / blood
  • Humans
  • Hypercalcemia / chemically induced
  • Lumbar Vertebrae / diagnostic imaging
  • Lumbar Vertebrae / metabolism
  • Male
  • Middle Aged
  • Osteoporosis / diagnostic imaging
  • Osteoporosis / drug therapy*
  • Patient Compliance
  • Vitamin D / therapeutic use*

Substances

  • Biomarkers
  • Hormones
  • Vitamin D
  • Calcitriol
  • eldecalcitol
  • Calcium