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Denosumab Prevents Bone Loss and Microarchitectural Deterioration in Premenopausal Women With Breast Cancer Receiving Estradiol Suppression Therapy: A Randomized Controlled Trial. | LitMetric

AI Article Synopsis

  • Suppression of ovarian function and aromatase inhibition (AI) in premenopausal women with early-stage ER-positive breast cancer improves disease-free survival but can lead to bone loss, prompting the investigation of denosumab (DMAB) as a potential preventative treatment.
  • In a 12-month double-blind trial involving 68 women, participants were divided to receive either DMAB or a placebo, with various bone density and strength metrics measured over time.
  • Results showed that DMAB effectively prevented bone mineral density loss across different sites, including the distal tibia, distal radius, lumbar spine, and hip, compared to the placebo group.

Article Abstract

Purpose: Suppression of ovarian function and aromatase inhibition (AI) increases disease-free survival in premenopausal women with estrogen receptor (ER)-positive early-stage breast cancer but accelerates bone loss. We therefore hypothesized that suppressing bone remodeling using denosumab (DMAB) would prevent bone loss in these women.

Methods: In a 12-month double-blind randomized trial, 68 women with ER-positive early-stage breast cancer commencing ovarian function suppression and AI were randomly assigned to 60 mg DMAB (n = 34) or placebo (PBO; n = 34) once every 6 months (at 0 and 6 months). Volumetric bone mineral density (BMD), microarchitecture, and estimated bone strength of the distal tibia and distal radius were measured using high-resolution peripheral quantitative computed tomography, and spine and hip BMD were measured using dual-energy X-ray absorptiometry at 0, 6, and 12 months. The primary end point and treatment effect was the mean adjusted between group difference (MAD; [95% CI]) in distal tibial total volumetric BMD over 12 months, with a single value tested over all time points. The study is registered with the Australian New Zealand Clinical Trials Registry (anzctr.org.au; identifier: ACTRN12616001051437).

Results: Intention-to-treat analysis included all 68 randomly assigned women. Over 12 months, compared with PBO, DMAB prevented the decrease in distal tibial total BMD (MAD, 20.8 mg HA/cm [95% CI, 17.3 to 24.2]), cortical BMD (42.9 mg HA/cm [95% CI, 32.1 to 53.9]), trabecular BMD (3.32 mg HA/cm [95% CI, 1.45 to 5.20], = .004), estimated stiffness (11.6 kN/m [95% CI, 7.6 to 15.6]), and failure load (563 N [95% CI, 388 to 736]). Findings were similar at the distal radius. Decreases in BMD at the lumbar spine (MAD, 0.13 g/cm [95% CI, 0.11 to 0.15]), total hip (0.08 g/cm [95% CI, 0.07 to 0.09], and femoral neck (0.06 g/cm [95% CI, 0.05 to 0.07]) were also prevented. All < .001 unless otherwise noted.

Conclusion: Treatment with DMAB at commencement of estradiol suppression therapy preserves BMD, bone microarchitecture, and estimated strength, and is likely to increase fracture-free survival.

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Source
http://dx.doi.org/10.1200/JCO.23.02309DOI Listing

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