Efficacy and safety of human parathyroid hormone-(1-84) in increasing bone mineral density in postmenopausal osteoporosis.
Daily sc injections of N-terminal analogs of PTH increase bone mass and decrease fractures in osteoporotic women. We investigated the efficacy and safety of human PTH-(1-84) (full-length PTH) in the treatment of postmenopausal osteoporosis in a double-blind, placebo-controlled study. The women (n = 50-53/group) self-administered PTH (50, 75, or 100 microg) or placebo by daily sc injection for 12 months. PTH treatment induced time- and dose-related increases in lumbar spine bone mineral density (BMD). The 100-microg dose increased BMD significantly at 3 months (+2.0%) and 12 months (+7.8%). BMD underestimated the anabolic effect of PTH in lumbar spine (bone mineral content, +10.0%) because bone area increased significantly (+2.0%). A nonsignificant decrease (-0.9%) in total hip BMD occurred during the first 6 months with the 100-microg dose, but this trend reversed (+1.6%) during the second 6 months. Bone turnover markers increased during the first half of the study and were maintained at elevated levels during the second 6 months. Protocol compliance was excellent (95-98%), and treatment was generally safe and well tolerated. Dose-related incidences of transient hypercalcemia occurred, but only one patient (100-microg group) was withdrawn because of repeated hypercalcemia. Thus, full-length PTH was efficacious and safe over 12 months.
Hodsman
Anthony B
AB
Department of Medicine, Lawson Health Research Institute, University of Western Ontario, London, Ontario, Canada N6A 4V2. anthony.hodsman@sjhc.london.on.ca
Hanley
David A
DA
Ettinger
Mark P
MP
Bolognese
Michael A
MA
Fox
John
J
Metcalfe
Anna J
AJ
Lindsay
Robert
R
D015502:Absorptiometry, Photon; D000368:Aged; D015415:Biomarkers; D015519:Bone Density / Q000187:drug effects*; D002118:Calcium / Q000097:blood / Q000652:urine; D005260:Female; D005272:Femur Neck / Q000378:metabolism; D006621:Hip Joint; D006801:Humans; D008159:Lumbar Vertebrae / Q000378:metabolism; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010281:Parathyroid Hormone / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies
D015415:Biomarkers; D010281:Parathyroid Hormone; D002118:Calcium