‘Many people with spinal fractures don't even realize they have a fracture’

Every year, 8.9 million osteoporotic fractures occur worldwide. That's one osteoporotic fracture every three seconds.

In particular, postmenopausal women, who are at increased risk for osteoporosis, are five times more likely to suffer another fracture within a year of their first osteoporotic fracture.

The spine accounts for 72 percent of these re-fractures, and spinal fractures are known to cause long-term and severe pain in patients, as well as severe mobility limitations, resulting in a lower quality of life than other osteoporotic fractures.

In Korea, Evenity (romosozumab), which has a dual mechanism of action that can simultaneously inhibit bone resorption and promote bone formation, is prescribed with reimbursement for treating patients at high risk of fracture who have experienced spinal fractures and is actively used in clinical fields.

In addition, leading domestic and international guidelines classify patients with a T-score of less than -3.0, patients with a previous fracture history and a T-score of -2.5 or less, and patients who have had a fracture in the last 24 months as an ultra-high-risk group for fracture/re-fracture. They recommend aggressive drug treatment from the beginning and Evenity as a first-line treatment.

Korea Biomedical Review spoke with Dr. Paul A. Anderson, a professor of orthopedics at the University of Wisconsin’s College of Medicine and an authority on spinal fracture treatment, to learn more about the importance of spinal fractures in osteoporotic fractures, the latest treatment advances, and the clinical utility of Evenity.

Question: Why do you think vertebral fractures are especially important in osteoporotic fractures?

Answer: Spinal fractures are sometimes referred to as "fragility fractures," "low-energy fractures," or "trauma fractures" because they can occur after a traumatic event, such as a fall, or even without any symptoms. As a result, about two-thirds of all patients don't realize they've suffered a fracture, and only about one-third of patients visit a doctor for osteoporosis screening after recognizing a fracture.

When a spinal fracture occurs, the impact on the patient is profound, with a hunched back and a shift in center of gravity that reduces height. In addition, one-third of spinal fracture patients suffer from chronic pain and require painkillers, especially narcotic painkillers. The problems associated with narcotic painkillers are well known, but they are exacerbated when used in older patients, who are more vulnerable to medication.

In addition, the physical and psychological impact of a spinal fracture at an advanced age is devastating. The body cannot function properly, resulting in severe activity limitations and the inability to live independently, requiring constant care. If care at home is not feasible, people are admitted to a nursing home, which in the United States accounts for about 3 percent of all spinal fracture patients. This inability to live independently and the lack of care can cause significant mental anxiety and concern for patients who are forced to spend the rest of their lives in institutions, including nursing homes.

Q: If two-thirds of people with spinal fractures are unaware of the fracture, it is expected to become very severe by the time they visit the hospital. Is there a way to detect it earlier?

A: In the U.S., people with osteoporosis have about a 22 percent chance of dying within a year of suffering a spinal fracture. This is relatively low when compared to the 30 percent mortality rate for hip fractures but still quite high. Given the significant risk of loss of independence and death, osteoporotic spine fractures are a very serious condition. If a vertebral fracture is not treated on time, more bone collapse will occur, resulting in a lowered spine, stooped posture, and reduced height.

Furthermore, vertebral fractures are a strong predictor of future fragility fractures. Patients who have experienced a vertebral fracture are more than three times more likely to develop fragility fractures, including additional hip and vertebral fractures, than those who have not, so it is important to consider vertebral fractures as a "sentinel sign" and to initiate appropriate osteoporosis treatment when these problems are present. However, osteoporosis often goes unrecognized by patients, which is why the role of primary care providers is so important. If you notice that your patient has lost more than two inches (about five centimeters) of height compared to their height in their 20s, you may suspect a vertebral fracture.

The degree of height loss can be used as a diagnostic measure of whether further testing is needed in the U.S. or Korea. Patients and healthcare providers should use these criteria to check their own height and, depending on the degree of height loss, visit a specialist for further evaluation.

Q: Evenity has changed the drug treatment paradigm for patients with osteoporotic fractures. How is it being used in the U.S.?

A: In the U.S., as in Korea, Evenity is prescribed for patients who meet specific criteria, including those at ultra-high risk of osteoporotic fracture, which accounts for about 10 percent of patients. Patients who have recently suffered a fracture are also included in the criteria for osteoporotic fracture and are eligible for bone formation stimulators.

Patients will be seen monthly to receive 12 injections of the drug, and after 12 months, their bone health will be reassessed through bone density testing. Patients will then be switched to Prolia (denosumab), bisphosphonates, or zoledronic acid to maintain the improved bone density. Taken together, the goal is to transition patients to a bone resorption inhibitor after 12 months of treatment with Evenity to further maximize the effectiveness of Evenity in patients at high risk for osteoporotic fracture.

In the U.S., there are other options for osteoprogenitors besides Evenity, and I prefer to prescribe Evenity for women with osteoporosis. In Korea, I understand that the indication has also been approved for male patients. However, in the U.S., different insurers cover different drugs, so decisions about drug use tend to be based on insurance coverage rather than personal preference.

Q: Korea has a high prevention rate of secondary osteoporotic fractures thanks to the high accessibility to the healthcare system and the reimbursement of Evenity. However, primary fracture prevention measures are still lacking. What’s your advice?

A: Osteoporosis is usually handled by primary care, which focuses on screening for diabetes, heart disease, and cancer, so osteoporosis tends to get pushed aside as a priority. In the U.S., there is also little assessment of the population needing primary fracture prevention. However, the death rate from osteoporotic fractures is higher than the death rate from breast cancer, myocardial infarction, or stroke combined.

I advise actively using the guidelines published by osteoporosis societies to identify patients who need bone density testing, including DEXA (Dual X-ray Absorptiometry) scans, to prevent fractures. In addition, public awareness is needed to create an environment that recognizes the importance of osteoporosis screening and treatment from a public health perspective.

Patient-level efforts are also important. We need to maintain a healthy diet, and I know that Koreans have very insufficient vitamin D and calcium intake. Supplementation with nutritional supplements and regular weight-bearing exercise can reduce the risk of falls and improve bone health. It’s important to avoid smoking and drinking alcohol, as they increase the risk of fractures. It is also important to emphasize the importance of maximizing bone density in your 20s, as it typically peaks in your 20s and declines after that.