Zoledronate for osteopenia
Trial question
What is the role of zoledronate in fracture prevention in postmenopausal females with osteopenia?
Study design
Multi-center
Double blinded
RCT
Population
2000 female patients.
Inclusion criteria: postmenopausal females with osteopenia.
Key exclusion criteria: an eGFR of < 30 mL/min/1.73 m² of body-surface area, major systemic disease, cancer in the previous 2 years, metabolic bone disease, or regular use bone-active drugs in the previous year, and prednisone at a dose of ≥ 2.5 mg per day.
Interventions
N=1000 zoledronate (four infusions of 5 mg at 18-month interval).
N=1000 placebo (four infusions of normal saline at 18-month interval).
Primary outcome
Fragility fractures at 18 months
12.2%
19%
19.0 %
14.3 %
9.5 %
4.8 %
0.0 %
Zoledronate
Placebo
Significant
decrease ▼
NNT = 14
Significant decrease in fragility fractures at 18 months (12.2% vs. 19%; HR 0.63, 95% CI 0.5 to 0.79).
Secondary outcomes
Significant decrease in height loss by at least 1 cm (32.2% vs. 41.3%; OR 0.67, 95% CI 0.55 to 0.82).
Safety outcomes
No significant difference in serious adverse events included fractures that resulted in hospitalization.
Significant differences in serious adverse events (820 vs. 1017; OR 0.84, 95% CI 0.70-1.00).
Conclusion
In postmenopausal females with osteopenia, zoledronate was superior to placebo with respect to fragility fractures at 18 months.
Reference
Reid IR, Horne AM, Mihov B et al. Fracture Prevention with Zoledronate in Older Women with Osteopenia. N Engl J Med. 2018 Dec 20;379(25):2407-2416.
Open reference URL