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Erik
The Effects of Parathyroid Hormone and Alendronate Alone or in Combination in Postmenopausal Osteoporosis
Dennis M. Black, Ph.D., Susan L. Greenspan, M.D., Kristine E. Ensrud, M.D., M.P.H., Lisa Palermo, M.A., Joan A. McGowan, Ph.D., Thomas F. Lang, Ph.D., Patrick Garnero, Ph.D., Mary L. Bouxsein, Ph.D., John P. Bilezikian, M.D., Clifford J. Rosen, M.D., for the PaTH Study Investigators
ABSTRACT
Background Parathyroid hormone increases bone strength primarily by stimulating bone formation, whereas antiresorptive drugs reduce bone resorption. We conducted a randomized, double-blind clinical study of parathyroid hormone and alendronate to test the hypothesis that the concurrent administration of the two agents would increase bone density more than the use of either one alone.
Methods A total of 238 postmenopausal women (who were not using bisphosphonates) with low bone mineral density at the hip or spine (a T score of less than -2.5, or a T score of less than -2.0 with an additional risk factor for osteoporosis) were randomly assigned to daily treatment with parathyroid hormone (1-84) (100 µg; 119 women), alendronate (10 mg; 60 women), or both (59 women) and were followed for 12 months. Bone mineral density at the spine and hip was assessed by dual-energy x-ray absorptiometry and quantitative computed tomography. Markers of bone turnover were measured in fasting blood samples.
Results The bone mineral density at the spine increased in all the treatment groups, and there was no significant difference in the increase between the parathyroid hormone group and the combination-therapy group. The volumetric density of the trabecular bone at the spine increased substantially in all groups, but the increase in the parathyroid hormone group was about twice that found in either of the other groups. Bone formation increased markedly in the parathyroid hormone group but not in the combination-therapy group. Bone resorption decreased in the combination-therapy group and the alendronate group.
Conclusions There was no evidence of synergy between parathyroid hormone and alendronate. Changes in the volumetric density of trabecular bone, the cortical volume at the hip, and levels of markers of bone turnover suggest that the concurrent use of alendronate may reduce the anabolic effects of parathyroid hormone. Longer-term studies of fractures are needed to determine whether and how antiresorptive drugs can be optimally used in conjunction with parathyroid hormone therapy.
Notice: To coincide with presentations at a meeting of the American Society for Bone and Mineral Research, this article was published at www.nejm.org on September 20, 2003. It will appear in the September 25 issue of the Journal.
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The Effects of Parathyroid Hormone, Alendronate, or Both in Men with Osteoporosis
Joel S. Finkelstein, M.D., Annmarie Hayes, M.S.N., R.N.C., N.P., Joy L. Hunzelman, M.S.N., N.P., Jason J. Wyland, B.A., Hang Lee, Ph.D., and Robert M. Neer, M.D.
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Finkelstein, J. S.
Neer, R. M.
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 µg 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.
Notice: To coincide with presentations at a meeting of the American Society for Bone and Mineral Research, this article was published at www.nejm.org on September 20, 2003. It will appear in the September 25 issue of the Journal.
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