Prevention of aromatase inhibitor-induced bone loss using risedronate: the SABRE trial.
PURPOSE To investigate the management of bone health in women with early breast cancer (EBC) who were scheduled to receive anastrozole. PATIENTS AND METHODS Postmenopausal women with hormone receptor-positive EBC were assigned to one of three strata by risk of fragility fracture. Patients with the highest risk (H) received anastrozole 1 mg/d plus risedronate 35 mg/wk orally. Patients with moderate-risk (M) were randomly assigned in a double-blind manner to anastrozole and risedronate (A + R) or to anastrozole and placebo (A + P). Patients with lower-risk (L) received anastrozole (A) alone. Calcium and vitamin D were recommended for all patients. Lumbar spine and total hip bone mineral density (BMD) were assessed at baseline, 12 months, and 24 months. Results At 24 months, in the M group, treatment with A + R resulted in a significant increase in lumbar spine and total hip BMD compared with A + P treatment (2.2% v -1.8%; treatment ratio, 1.04; P < .0001; and 1.8% v -1.1%; treatment ratio, 1.03; P < .0001, respectively). In the H stratum, lumbar spine and total hip BMD increased significantly (3.0%; P = .0006; and 2.0%; P = .0104, respectively). Patients in the L stratum showed a significant decrease in lumbar spine BMD (-2.1%; P = .0109) and a numerical decrease in total hip BMD (-0.4%; P = .5988). Safety profiles for anastrozole and risedronate were similar to those already established. CONCLUSION In postmenopausal women at risk of fragility fracture who were receiving adjuvant anastrozole for EBC, the addition of risedronate at doses established for preventing and treating osteoporosis resulted in favorable effects in BMD during 24 months.
Van Poznak
Catherine
C
University of Michigan Comprehensive Cancer Center, 1500 E Medical Center Dr, C346 Med Inn Building, Ann Arbor, MI 48109-5848, USA. cvanpoz@umich.edu
Hannon
Rosemary A
RA
Mackey
John R
JR
Campone
Mario
M
Apffelstaedt
Justus P
JP
Clack
Glen
G
Barlow
David
D
Makris
Andreas
A
Eastell
Richard
R
D000368:Aged; D000077384:Anastrozole; D047072:Aromatase Inhibitors / Q000009:adverse effects*; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D050723:Fractures, Bone / Q000139:chemically induced / Q000517:prevention & control*; D020249:Hormone Replacement Therapy; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D009570:Nitriles / Q000009:adverse effects*; D015663:Osteoporosis, Postmenopausal / Q000139:chemically induced / Q000517:prevention & control*; D017698:Postmenopause; D011379:Prognosis; D000068296:Risedronic Acid; D015996:Survival Rate; D016896:Treatment Outcome; D014230:Triazoles / Q000009:adverse effects*
D047072:Aromatase Inhibitors; D050071:Bone Density Conservation Agents; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole; D000068296:Risedronic Acid; D012968:Etidronic Acid