Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism

Kidney Int. 2015 Apr;87(4):846-56. doi: 10.1038/ki.2014.349. Epub 2014 Oct 22.


The multicenter, single-arm BONAFIDE study characterized the skeletal response to cinacalcet in adult dialysis patients with plasma parathyroid hormone (PTH) levels of 300 pg/ml or more, serum calcium of 8.4 mg/dl or more, bone-specific alkaline phosphatase over 20.9 ng/ml and biopsy-proven high-turnover bone disease. Of 110 enrolled patients, 77 underwent a second bone biopsy with quantitative histomorphometry after 6-12 months of cinacalcet treatment. The median PTH decreased from 985 pg/ml at baseline to 480 pg/ml at the end of study (weeks 44-52). Bone formation rate/tissue area decreased from 728 to 336 μm(2)/mm(2)/day, osteoblast perimeter/osteoid perimeter decreased from 17.4 to 13.9%, and eroded perimeter/bone perimeter decreased from 12.7 to 8.3%. The number of patients with normal bone histology increased from none at baseline to 20 at 12 months. Two patients had adynamic bone at the end of study with a PTH under 150 pg/ml, and one patient with overt hypophosphatemia at baseline that reoccurred during follow-up developed osteomalacia. Thus, long-term treatment with cinacalcet substantially reduced PTH, diminished the elevated bone formation rate/tissue area, lowered several biochemical markers of high-turnover bone disease toward normal, and generally improved bone histology. Twenty patients had normal bone histology at follow-up, whereas most had mild hyperparathyroidism or mixed uremic osteodystrophy.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Alkaline Phosphatase / blood
  • Bone Diseases, Metabolic / blood
  • Bone Diseases, Metabolic / etiology
  • Bone Diseases, Metabolic / pathology*
  • Bone Resorption / blood
  • Calcimimetic Agents / adverse effects
  • Calcimimetic Agents / therapeutic use*
  • Calcium / blood
  • Cinacalcet / adverse effects
  • Cinacalcet / therapeutic use*
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / blood
  • Hyperparathyroidism, Secondary / complications
  • Hyperparathyroidism, Secondary / drug therapy*
  • Male
  • Middle Aged
  • Osteogenesis / drug effects*
  • Parathyroid Hormone / blood
  • Renal Dialysis
  • Renal Insufficiency, Chronic / therapy
  • Time Factors
  • Young Adult


  • Calcimimetic Agents
  • Parathyroid Hormone
  • Alkaline Phosphatase
  • Calcium
  • Cinacalcet