- In women with osteoporosis and diabetes, denosumab increased bone mineral density (BMD) and reduced vertebral fractures and overall long-term fracture incidence in this post hoc analysis.
- Nonvertebral fracture incidence was elevated during study year 2 but returned to placebo levels in follow-up.
Why this matters
- People with diabetes are at increased fracture risk.
- Post hoc analysis of 3-year FREEDOM study and 7-year extension, including 7808 postmenopausal women with osteoporosis, of whom 508 (6.5%) had diabetes at baseline.
- Funding: Amgen Inc.
- During FREEDOM, percentage change from baseline in lumbar spine, total hip, and femoral neck BMD was significantly higher with denosumab vs placebo regardless of diabetes status, as were BMD increases at all skeletal sites during study extension.
- During FREEDOM, new vertebral fracture risk was significantly reduced with denosumab vs placebo in patients with diabetes (cumulative incidence, 1.6% with denosumab vs 8.0% with placebo; risk ratio, 0.20; P=.001).
- Higher cumulative nonvertebral fracture incidence seen in denosumab-treated (11.7%) vs placebo-treated patients (5.9%) with diabetes (HR, 1.94; P=.046), but not without diabetes (denosumab vs placebo: HR, 0.74; P=.001).
- During extension, both new vertebral and nonvertebral fractures remained low in denosumab group with diabetes.
- Post hoc subgroup analysis.
- Small patient numbers.
- Glycemic control not assessed.