Risedronate Prevents Bone Loss in Breast Cancer Survivors: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Purpose-Limited data are available on the efficacy of oral bisphosphonate therapy in breast cancer survivors. Our goal was to examine prevention of breast cancer-related bone loss in this cohort.Patients and Methods-Eighty-seven postmenopausal women after chemotherapy for breast cancer were randomly assigned to once-weekly risedronate 35 mg or placebo for 24 months. Outcomes included bone mineral density (BMD) and turnover markers. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTERESTAlthough all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author ManuscriptResults-At study initiation, 13% of patients were on an aromatase inhibitor (AI). After 24 months, there were differences of 1.6 to 2.5% (P < .05) at the spine and hip BMD between the placebo and risedronate groups. At study completion, 44% were on an AI. Adjusting for an AI, women on placebo plus AI had a decrease in BMD of (mean ± SE) 4.8% ± 0.8% at the spine and 2.8% ± 0.5% at the total hip (both P < .001). In women on risedronate + AI, the spine decreased by 2.4% ± 1.1% (P < .05) and was stable at the hip. Women in the placebo group not on an AI, maintained BMD at the spine, and had a 1.2% ± 0.5% loss at the total hip (P < .05). Women who received risedronate but no AI had the greatest improvement in BMD of 2.2% ± 0.9% (P < .05) at the total hip. Bone turnover was reduced with risedronate. There were no differences in adverse events between the groups.Conclusion-We conclude that in postmenopausal women with breast cancer with or without AI therapy, once-weekly oral risedronate was beneficial for spine and hip BMD, reduced bone turnover, and was well tolerated.

Osteonecrosis of the jaw and use of bisphosphonates in adjuvant breast cancer treatment: a metanalysis

“…Evidence from clinical trials suggests that use of bisphosphonates in adjuvant setting may be effective in the treatment and prevention of CTIBL [7][8][9][10].…”

Medication-induced osteoporosis: screening and treatment strategies

“…Data from clinical trials in over 4100 patients support the use of intravenous or oral bisphosphonates and denosumab to prevent AI-induced bone loss in postmenopausal women with breast cancer [Hadji et al 2011]. Compared with risedronate, zoledronic acid (4 mg intravenously every 6 months) is more effective at preventing AI-induced bone loss and increases disease-free survival in patients with breast cancer [Brufsky et al 2008;Greenspan et al 2008;Gnant et al 2009]. In several large trials, intravenous zoledronic acid is effective when started simultaneously with AIs or when delayed after a period of AI therapy [Eidtmann et al 2010;Brufsky et al 2009;Hines et al 2009].…”

Review: Adjuvant bisphosphonates in endocrine-responsive breast cancer: what is their place in therapy?

“…Among patients with osteoporosis (n ¼ 15) who received anastrozole plus risedronate there was a nonsignificant increase in hip BMD (+1.8%; p ¼ 0.131) and a significant increase in lumbar spine BMD (+4.1%; p ¼ 0.008; Figure 2a) [Confavreux et al 2007]. A separate study in postmenopausal women receiving chemotherapy for breast cancer (n ¼ 87) examined the combination of risedronate (35 mg/week PO) with endocrine therapy for 2 years [Greenspan et al 2008]. After 2 years, patients in the placebo arm had spine and hip BMD that were 1.62.5% lower than that of patients in the risedronate arm (p < 0.05) [Greenspan et al 2008].…”

“…A separate study in postmenopausal women receiving chemotherapy for breast cancer (n ¼ 87) examined the combination of risedronate (35 mg/week PO) with endocrine therapy for 2 years [Greenspan et al 2008]. After 2 years, patients in the placebo arm had spine and hip BMD that were 1.62.5% lower than that of patients in the risedronate arm (p < 0.05) [Greenspan et al 2008]. In the placebo arm, patients who had not received AI therapy had stable BMD, and those with AI therapy lost BMD at the spine and hip (À4.8 and À2.8%, respectively; p < 0.001 for both).…”