Eldecalcitol Add-on to Risedronate Reduces Bone Loss From Aromatase Inhibitors in Postmenopausal Breast Cancer Patients
Abstract
CONTEXT: Aromatase inhibitors (AIs) cause bone loss and increase fracture risk in women with hormone receptor-positive early-stage breast cancer (HR + EBC). Bone antiresorptive agents are recommended for patients at risk of fragility fractures. Eldecalcitol, combined with bisphosphonate, increases bone mineral density (BMD) in primary osteoporosis.
OBJECTIVE: To determine the effect of eldecalcitol (0.75 ug/day) add-on therapy to risedronate (17.5 mg/week) on bone quantity and quality in women treated with AI.
DESIGN: Open-label randomized control trial.
SETTING: Postmenopausal women with HR + EBC (TNM stage 0-3A) treated with risedronate for more than 12 months.
PATIENTS: Two hundred patients were enrolled; 196 patients were eligible for the full analysis set after excluding those without follow-up BMD data. Participants were advised to take vitamin D and calcium, yet many were vitamin D deficient or insufficient.
INTERVENTION: Participants were randomly assigned in a 1:1 ratio to receive either eldecalcitol add-on therapy or risedronate monotherapy.
MAIN OUTCOME MEASURE: The primary outcome was the group difference in the change of lumbar spine (LS)-BMD in 24 months. Secondary outcomes included femoral neck (FN)-BMD, total hip (TH)-BMD, trabecular bone score (TBS), and the incidence of vertebral and nonvertebral fractures.
RESULTS: The increase at LS-, FN-, and TH-BMD at 24 months was larger in the add-on therapy group than in the monotherapy group, with a group difference…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 196 participants or records.
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