Daily oral pamidronate in women and men with osteoporosis: a 3-year randomized placebo-controlled clinical trial with a 2-year open extension.
The efficacy and safety of oral pamidronate was examined in a double-blind, placebo-controlled trial in women and men with established osteoporosis. Seventy-eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or placebo for 3 years followed by 150 mg/day of pamidronate for an additional 2 years. In addition, all patients received 400 U/day of cholecalciferol and 500 mg/day of elemental calcium. Pamidronate increased significantly bone mineral density of the lumbar spine (LS-BMD) and of the femoral neck (FN-BMD). The total increase in BMD of the spine after 5 years of treatment was 14.3%. Lateral spine radiographs were obtained at baseline and after 3 years of treatment. Fractures of previously normal vertebrae occurred in 15 of 45 patients treated with placebo (33.3%) and in 5 of 46 patients treated with pamidronate (11%). The relative risk was 0.33 (95% CI, 0.14-0.77). Treatment was well tolerated and there was no difference in gastrointestinal toxicity between pamidronate and placebo-treated patients. One hundred fifty milligrams daily of pamidronate is an effective and safe treatment of women and men with established osteoporosis.
Brumsen
Caroline
C
Department of Endocrinology and Metabolic Diseases, Leiden University Medical Center, The Netherlands.
Papapoulos
Socrates E
SE
Lips
Paul
P
Geelhoed-Duijvestijn
Petronella H L M
PH
Hamdy
Neveen A T
NA
Landman
Jan Otto
JO
McCloskey
Eugene V
EV
Netelenbos
J Coen
JC
Pauwels
Ernest K J
EK
Roos
Jan C
JC
Valentijn
Rob M
RM
Zwinderman
Aeilko H
AH
D000284:Administration, Oral; D000368:Aged; D015519:Bone Density; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006615:Hip / Q000473:pathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000473:pathology; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy* / Q000473:pathology; D000077268:Pamidronate; D010919:Placebos
D004164:Diphosphonates; D010919:Placebos; D000077268:Pamidronate