Risedronate prevents bone loss in early postmenopausal women: a prospective randomized, placebo-controlled trial.
OBJECTIVE
To assess the efficacy and tolerability of risedronate, a pyridinyl bisphosphonate, in preventing loss of bone mineral density (BMD) of the lumbar spine and proximal femur in early postmenopausal women.


METHODS
A total of 383 patients were randomly assigned to receive risedronate 2.5 or 5 mg or placebo once daily for 24 months. All patients received 1 g elemental calcium daily. BMD was measured by dual X-ray absorptiometry at baseline and at 3, 6, 12, 18, and 24 months.


RESULTS
Risedronate 5 mg significantly increased BMD at the lumbar spine and femoral neck and trochanter in early postmenopausal women. Significant results were observed as early as 3 months. In the control calcium-supplemented group, BMD decreased steadily at each site throughout the study. The mean percentage change from baseline in BMD in the risedronate 5 mg group was significantly different from that in the control group at each determination at each site. At 24 months, the differences were 4.5 +/- 0.45% at the lumbar spine, 3.3 +/- 0.49% at the femoral neck, and 4.3 +/- 0.67% at the femoral trochanter. Risedronate 2.5 mg maintained BMD at each site, although the effect was less pronounced than that of risedronate 5 mg. Risedronate was well tolerated and was not associated with an increased incidence of overall or upper gastrointestinal adverse events.


CONCLUSIONS
Risedronate 5 mg prevents bone loss in early postmenopausal women, is well tolerated, and represents an effective choice to maintain bone mass and prevent osteoporosis.
Hooper
M J
MJ
The University of Sydney, Endocrinology and Metabolism, C64, Level 6, Concord Hospital Medical Centre, Concord Repatriation General Hospital, Concord, New South Wales 2139, Australia.
Ebeling
P R
PR
Roberts
A P
AP
Graham
J J
JJ
Nicholson
G C
GC
D'Emden
M
M
Ernst
T F
TF
Wenderoth
D
D
D015502:Absorptiometry, Photon; D000328:Adult; D000596:Amino Acids / Q000097:blood; D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D003404:Creatinine / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005269:Femur; D006801:Humans; D008159:Lumbar Vertebrae; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D011446:Prospective Studies; D000068296:Risedronic Acid; D016896:Treatment Outcome
D000596:Amino Acids; D015415:Biomarkers; D050071:Bone Density Conservation Agents; C036020:deoxypyridinoline; D003404:Creatinine; D000068296:Risedronic Acid; D012968:Etidronic Acid