Phase III randomized, placebo-controlled, double-blind trial of risedronate for the prevention of bone loss in premenopausal women undergoing chemotherapy for primary breast cancer.
OBJECTIVE
Risedronate prevents bone loss in postmenopausal women. The purpose of this study was to determine whether risedronate prevents bone loss in premenopausal women undergoing chemotherapy for breast cancer.


METHODS
Premenopausal women undergoing chemotherapy for breast cancer were treated with oral calcium 600 mg and vitamin D 400 U daily and randomly assigned to receive oral risedronate 35 mg weekly or placebo, with all these therapies beginning within a month of the start of chemotherapy. Most chemotherapy regimens included anthracyclines, taxanes, or cyclophosphamide. Bone mineral density (BMD) was measured at baseline and 1 year. The primary end point was the change in lumbar spine (LS) BMD from baseline to 1 year.


RESULTS
A total of 216 women enrolled; 170 women provided BMD data at 1 year. There was no difference in the mean change or percent change in LS BMD between groups, with a loss of 4.3% in the risedronate arm and 5.4% for placebo at 1 year (P = .18). Loss of BMD at the femoral neck and total hip were also similar between treatment groups. Risedronate was well tolerated, with no significant differences in adverse events compared with placebo, except that arthralgias and chest pain were worse in those receiving the placebos.


CONCLUSIONS
Risedronate did not prevent bone loss in premenopausal women undergoing adjuvant chemotherapy for breast cancer.
Hines
Stephanie L
SL
Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL 32224, USA. hines.stephanie@mayo.edu
Mincey
Betty Anne
BA
Sloan
Jeff A
JA
Thomas
Sachdev P
SP
Chottiner
Elaine
E
Loprinzi
Charles L
CL
Carlson
Mark D
MD
Atherton
Pamela J
PJ
Salim
Muhammad
M
Perez
Edith A
EA
D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001851:Bone Diseases, Metabolic / Q000139:chemically induced / Q000517:prevention & control*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002118:Calcium / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D012968:Etidronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000517:prevention & control; D017697:Premenopause; D000068296:Risedronic Acid; D014807:Vitamin D / Q000008:administration & dosage
D000970:Antineoplastic Agents; D050071:Bone Density Conservation Agents; D014807:Vitamin D; D000068296:Risedronic Acid; D012968:Etidronic Acid; D002118:Calcium