Avoidance of vertebral fractures in men with idiopathic osteoporosis by a three year therapy with calcium and low-dose intermittent monofluorophosphate

Osteoporos Int. 1998;8(1):47-52. doi: 10.1007/s001980050047.


There are currently no trial-based recommendations for the treatment of idiopathic osteoporosis in men. A prospective, controlled, randomized 3-year study was conducted to evaluate the effects of intermittent, low-dose fluoride combined with continuous calcium supplementation on bone mass and future fracture events in men with this disease. Sixty-four men with idiopathic osteoporosis (mean age 53 years; mean T-score at L2-4, -2.75) and no previous vertebral fractures were randomly assigned to two treatment groups. Group A received intermittent (3 months on, 1 month off) treatment with monofluorophosphate 114 mg/day (i.e. 15 mg fluoride ions) plus continuous calcium supplementation (950-1000 mg/day). Group B received continuous calcium (1000 mg/day) alone. Bone mineral density was measured at the lumbar spine, hip and radius at 6-months intervals; thoracic and lumbar spine radiographs were obtained every 12 months. In group A bone density increased at all sites (by between +1.2% and +8.8%), while group B showed moderate decreases (by between -1.4% and -5.2%). After 36 months, bone densities at all sites in group A were significantly higher than those of group B. Three patients (10%) in group A suffered a total of 4 vertebral fractures versus 12 patients (40%) with 17 fractures in group B (p = 0.008). Non-vertebral fractures occurred in 3 patients in group A versus 11 in group B, though this difference was not significant. Back pain was significantly reduced in group A and unchanged in group B (after 3 years p = 0.0003). All side-effects were mild and transient. Early treatment of idiopathic osteoporosis in the male using the fluoride-calcium regimen we tested can improve cancellous and cortical bone density, reduce the incidence of vertebral fractures and attenuate back pain.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Back Pain / drug therapy
  • Bone Density / drug effects
  • Calcium / therapeutic use*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Fluorides / administration & dosage*
  • Fluorides / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Osteoporosis / complications*
  • Osteoporosis / drug therapy
  • Osteoporosis / physiopathology
  • Phosphates / administration & dosage*
  • Phosphates / therapeutic use
  • Prospective Studies
  • Spinal Fractures / etiology
  • Spinal Fractures / physiopathology
  • Spinal Fractures / prevention & control*


  • Phosphates
  • fluorophosphate
  • Fluorides
  • Calcium