#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.
I guess I will not prescribe it as costly and has cv side effect
I learned the hard way that MOH will not cover romosozumab if patient has previously been on any other osteoporosis med. So I should not have started risidronate while waiting to see her rheumatologist
agree. way too expensive
TOO EXPENSIVE TO PRESCRIBE WITH NO DRUG COVERAGE.
QuALY???
Even if the pt has drug coverage it works out to 640,000 dollars to prevent one fracture. Crazy