The effects of parathyroid hormone, alendronate, or both in men with osteoporosis

N Engl J Med. 2003 Sep 25;349(13):1216-26. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20.

Abstract

Background: Because parathyroid hormone increases both bone formation and bone resorption, it is possible that combining parathyroid hormone with an antiresorptive agent will enhance its effect on bone mineral density.

Methods: We randomly assigned 83 men who were 46 to 85 years of age and had low bone density to receive alendronate (10 mg daily; 28 men), parathyroid hormone (40 microg subcutaneously daily; 27 men), or both (28 men). Alendronate therapy was given for 30 months; parathyroid hormone therapy was begun at month 6. The bone mineral density of the lumbar spine, proximal femur, radial shaft, and total body was measured every six months with the use of dual-energy x-ray absorptiometry. Trabecular bone mineral density of the lumbar spine was measured at base line and month 30 by means of quantitative computed tomography. Serum alkaline phosphatase levels were measured every six months. The primary end point was the rate of change in the bone mineral density at the posteroanterior spine.

Results: The bone mineral density at the lumbar spine increased significantly more in men treated with parathyroid hormone alone than in those in the other groups (P<0.001 for both comparisons). The bone mineral density at the femoral neck increased significantly more in the parathyroid hormone group than in the alendronate group (P<0.001) or the combination-therapy group (P=0.01). The bone mineral density of the lumbar spine increased significantly more in the combination-therapy group than in the alendronate group (P<0.001). At 12 months, changes in the serum alkaline phosphatase level were significantly greater in the parathyroid hormone group than in the alendronate group or the combination-therapy group (P<0.001 for both comparisons).

Conclusions: Alendronate impairs the ability of parathyroid hormone to increase the bone mineral density at the lumbar spine and the femoral neck in men. This effect may be attributable to an attenuation of parathyroid hormone-induced stimulation of bone formation by alendronate.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Absorptiometry, Photon
  • Aged
  • Aged, 80 and over
  • Alendronate / adverse effects
  • Alendronate / therapeutic use*
  • Alkaline Phosphatase / blood
  • Bone Density / drug effects
  • Bone Remodeling / drug effects
  • Calcium / blood
  • Calcium / therapeutic use
  • Calcium / urine
  • Drug Therapy, Combination
  • Femur Neck / diagnostic imaging
  • Femur Neck / pathology
  • Humans
  • Injections, Subcutaneous
  • Lumbar Vertebrae / diagnostic imaging
  • Lumbar Vertebrae / pathology
  • Male
  • Middle Aged
  • Osteoporosis / diagnostic imaging
  • Osteoporosis / drug therapy*
  • Osteoporosis / pathology
  • Patient Compliance
  • Radius / diagnostic imaging
  • Radius / pathology
  • Teriparatide / adverse effects
  • Teriparatide / therapeutic use*
  • Vitamin D / therapeutic use

Substances

  • Teriparatide
  • Vitamin D
  • Alkaline Phosphatase
  • Calcium
  • Alendronate