Cardiometabolic Effects of Denosumab in Premenopausal Women With Breast Cancer Receiving Estradiol Suppression: RCT
Authors' conclusion
In premenopausal women receiving estradiol suppression, denosumab decreases some measures of fat mass with no detectable effects on other measures of body composition or metabolic parameters.
Study context
- Population
- Premenopausal women with breast cancer initiating ovarian function suppression and aromatase inhibition
- Participants
- 68 women
- Comparison
- Denosumab 60 mg vs placebo at baseline and 6 months
Methodological detailsprespecified secondary analysis, double-blind, placebo-controlled, 12-month
- Prespecified secondary analysis
- Double-blind
- Placebo-controlled
- 12-month
Primary result
As reported in the abstract
12 months
Each group vs placeboEstimate (95% CI)P value
Denosumab
mean adjusted difference (android fat mass) −266 g(−453 to −79)
P = 0.02Denosumab
mean adjusted difference (gynoid fat mass) −452 g(−783 to −122)
P = 0.03Further findings
| Outcome | Mean adjusted difference (total fat mass) (g) (CI) | P value | |
|---|---|---|---|
| Total fat mass and waist circumference · 12 monthsDenosumabvs PlaceboNot significant | −1792 (−3346 to −240) | P = 0.08 | |
| −4000−200002000Difference, g (linear scale) |
| Outcome | Mean adjusted difference (waist circumference) (cm) (CI) | P value | |
|---|---|---|---|
| Total fat mass and waist circumference · 12 monthsDenosumabvs PlaceboNot significant | - 3.77 (−6.76 to −0.79) | P = 0.06 | |
| −10−505Difference, cm (linear scale) |
Lean mass, body mass index (BMI), hip circumference, fasting glucose, HOMA-IR, lipid profile · 12 months
- No significant treatment effects detected
Original publication
Cardiometabolic Effects of Denosumab in Premenopausal Women With Breast Cancer Receiving Estradiol Suppression: RCT. J Clin Endocrinol Metab. Published 5 January 2024. doi:10.
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