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Prevention of bone loss in survivors of breast cancer : A randomized , double-blind , placebo-controlled clinical trial . BACKGROUND Few data are available on the safety and efficacy of once-weekly oral bisphosphonate therapy in breast cancer survivors . OBJECTIVE Our objective was to determine whether risedronate , 35 mg weekly , is efficacious and safe in preventing bone loss associated with chemotherapy-induced menopause . DESIGN The study was a randomized , double-blind , placebo-controlled clinical trial over 12 months . SETTING AND PARTICIPANTS Participants included 87 newly postmenopausal women with status post chemotherapy , recruited from a breast cancer clinic in an academic medical center . INTERVENTION Participants were randomly assigned to receive risedronate 35 mg/wk or placebo . MAIN OUTCOME MEASURES The primary outcomes were the 12-month changes in spine and hip bone mineral density . Secondary outcomes included changes in markers of bone resorption ( urine N-telopeptide cross-linked collagen type I ) and formation ( osteocalcin , N-terminal propeptide of type I procollagen , and bone-specific alkaline phosphatase ) . RESULTS After 12 months , bone mineral density increased by 1.2 % at the spine and 1.3 % at the hip in women on risedronate vs. significant decreases for women in the placebo group of 0.9 % at the spine and 0.8 % at the hip ( P < 0.01 , difference between groups ) . N-telopeptide cross-linked collagen type I , a marker of bone resorption , decreased by 19.3 % , and N-terminal propeptide of type I procollagen , a marker of bone formation , decreased by 26.6 % in participants on active therapy compared with increases in the control group . Risedronate was well tolerated , and the retention rate was 95 % at 1 yr . CONCLUSIONS Risedronate once weekly prevented bone loss and reduced bone turnover in women with breast cancer treated with chemotherapy . Early measures to prevent bone loss should be considered in this cohort of breast cancer survivors .
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Intervention_Pharmacological
bisphosphonate therapy
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Intervention_Pharmacological
risedronate
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
risedronate
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Intervention_Control
placebo
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Intervention_Pharmacological
risedronate
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Intervention_Pharmacological
Risedronate
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Intervention_Pharmacological
Risedronate
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Outcome_Physical
12-month changes in spine and hip bone mineral density .
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Outcome_Physical
changes in markers of bone resorption ( urine N-telopeptide cross-linked collagen type I ) and formation ( osteocalcin , N-terminal propeptide of type I procollagen , and bone-specific alkaline phosphatase )
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Outcome_Physical
bone mineral density
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Outcome_Physical
N-telopeptide cross-linked collagen type I
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Outcome_Other
tolerated
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Outcome_Other
retention rate
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Participant_Condition
survivors of breast cancer :
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Participant_Condition
breast cancer survivors .