#378 Tony Romo-sozumab: Winning touchdown in osteoporosis or interception for the loss?
CLINICAL QUESTION
What is the efficacy and safety of romosozumab in postmenopausal women with osteoporosis?
BOTTOM LINE
In a single randomized, controlled trial (RCT) of postmenopausal women with fracture history, romosozumab was more effective than alendronate at reducing major osteoporotic fractures (7% versus 10%) including hip fractures (2% versus 3%) but increased cardiovascular events (0.8% versus 0.3%) at 2.7 years. High cost and potential cardiovascular harm may limit use.
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EVIDENCE
- Differences statistically significant unless noted.
- Efficacy: Two main RCTs of romosozumab 210mg subcutaneous monthly (mean age: 70).1-2
- Versus alendronate 70mg weekly for 12 months, followed by open-label alendronate for additional 12 months in both groups. 4093 women (96%: vertebral fracture; baseline FRAX ~20%).1 At 24-32 months:
- Major osteoporotic fractures: 7.1% versus 10% (alendronate), number needed to treat (NNT)=35.
- Hip fracture: 2.0% versus 3.2% (alendronate), NNT=84.
- Clinical vertebral fracture: 0.9% versus 2.1% (alendronate), NNT=79.
- Versus placebo for 12 months, followed by denosumab subcutaneously 60mg every 6 months for one year in both groups. 7180 women with T-score -2.5 to -3.5 at hip/femoral neck (~20% previous fracture, baseline FRAX ~13%) at 12 months: 2
- Major osteoporotic fracture: 1.1% versus 1.8% (placebo), NNT=143.
- Hip, non-vertebral fracture: No difference.
- Vertebral fracture: 0.5% versus 1.8% (placebo), NNT=77.
- Systematic reviews with additional small RCTs: Similar.3,4
- Versus alendronate 70mg weekly for 12 months, followed by open-label alendronate for additional 12 months in both groups. 4093 women (96%: vertebral fracture; baseline FRAX ~20%).1 At 24-32 months:
- Adverse Events: Nine systematic reviews, romosozumab versus placebo.5-13 Most comprehensive review (nine RCTs, 12,796 postmenopausal women):7
- Injection site reactions: 5.3% versus 2.9% (placebo), number needed to harm (NNH)=44 at 6-12 months.
- Osteonecrosis of jaw, atypical femur fracture: <1%, no statistical difference.
- Consistent with other reviews.5,6,8,9,14-16
- Cardiovascular risk: Focusing on above main RCTs:
- Cardiac ischemic events:10.8% versus 0.3% (alendronate), NNH=206
- Not reported in placebo-controlled trial.2
- Cardiac ischemic events:10.8% versus 0.3% (alendronate), NNH=206
- Limitations: Industry funded;1-2 few non-vertebral fractures in placebo-controlled RCT;2 no comparisons versus denosumab.
CONTEXT
- Guideline: Consider romosozumab first-line if:14
- Vertebral fracture (within last two years) with vertebral height loss >40%, or
- >1 vertebral fracture and T-score ≤-2.5.
- Duration: Approved for one year, then anti-resorptive agent.14
- Yearly cost:15,16
- Romosozumab ~ $8200.
- Risedronate/alendronate: ~$480.
- Denosumab: ~$800.
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Too expensive
I don’t think I have any patients willing to spend $8000 to be the one out of 80 to avoid a hip fracture.
Indications limitées.
I agree. Perhaps a bit more effective for fracture reduction but CV issues and cost will limit use. I am not likely to prescribe this.