“Prolia demonstrated a long-term treatment effect"

the best option for preventing bone fractures

David Dempster (Hons), Professor at Columbia University in the United States

Demonstrated reduction in bone fracture risk through 10 years of clinical studies.

“low awareness regarding the risk of osteoporosis…it’s important to continue treatment to maintain bone density”

David Dempster (Hons), Professor at Columbia University in the United States

“Prolia has consistently been proven to increase bone density based on clinical trials conducted over 10 years.

 

Patients prescribed with Prolia have demonstrated such.

 

Based on this evidence we hope that Prolia’s preventative effect on bone fracture becomes known in South Korea.“ During a recent meeting with Daily Pharm, David Dempster, (Hons) Professor at Columbia University in the U.S., assessed the osteoporosis treatment, Prolia (denosumab), as such.

 

Osteoporosis is a chronic disease that weakens bones due to lowered bone density, and it cannot be completely recovered.

 

After the diagnosis of osteoporosis, inadequate treatment may lead to a bone fracture with a minor fall in daily life.

 

Once an osteoporotic fracture occurs, the risk of another bone fracture increases tenfold, and repeated incidents lead to a worsened prognosis.

 

Preventing bone fracture through a long-term and consistent treatment is critical for osteoporosis.

 

Since May, the Ministry of Health and Welfare (MOHW) expanded the National Health Insurance criteria for receiving major osteoporosis medications, including Prolia.

 

Previously, patients could receive reimbursement at a T-score below -2.5, a bone mineral density test criteria.

 

After the reimbursement revision, osteoporosis patients can receive reimbursement for osteoporosis medications for up to two years at a T score of over -2.5 or above or below -2.0 at the follow-up tests.

 

Professor Dempster said that expanding the reimbursement criteria was the right decision, and emphasized the importance of preventing osteoporotic bone fractures through continuous medication treatment.

 

Real World Data over 10 years demonstrated the effectiveness of Prolia Based on 10-year FREEDOM and FREEDOM Extension studies, Prolia showed a higher effect on reducing bone fractures compared to alendronate, a previous osteoporosis medication.

 

In a real-world study conducted among 478,651 postmenopausal osteoporosis patients in the United States with no prior treatment history, Prolia reduced the risk of non-vertebral fractures, excluding hip fractures by 50% and major osteoporotic fractures by 39% compared to alendronate.

 

After one year of treatment, Prolia demonstrated a greater reduction in bone fractures than alendronate.

 

Studies indicate that the longer the treatment duration, more significant the decrease in the risk of bone fractures.

 

“Prolia is a superior medication compared to conventional treatments in many aspects.

 

This treatment provides effective results and offers high convenience with its once-every-six-month dosing schedule.

 

Most elderly osteoporosis patients often already take medications for other conditions, making it burdensome to take additional oral medications.

 

Additionally, some treatments have complex dosing regimens, causing various challenges in administration,“ Professor Dempster said.

 

With previous treatments like alendronate, most patients typically reach a plateau in bone density improvement after about 2 to 3 years of therapy.

 

However, Prolia has shown a consistent increase in bone density throughout the treatment period due to its unique mechanism of action compared to other medications.

 

“Prolia has been confirmed to be easy to administer and continuously increase bone density through long-term clinical studies.

 

According to presentations at various conferences, including the Korean Society for Bone and Mineral Research, Prolia’s data repeatedly indicate that it offers superior long-term improvement in bone density and reduction in fracture risk than conventional treatments,“ Professor Dempster said.

 

“While existing treatments are good options, it may be necessary to recognize that better therapies have been developed.

 

I hope that in Korea, there will be a growing understanding that Prolia's effectiveness is superior to conventional treatments, like that in the United States,” he added.

 

A sequential treatment regimen is recommended for osteoporosis…concerns for the disease awareness Osteoporosis is a condition in which bone density (BMD) decreases, leading to structural damage to the bones themselves.

 

Therefore, after restoring bone density to a certain level using bone-forming agents, maintaining the increased bone density with bone resorption inhibitors is proposed as an appropriate treatment method.

 

In this context, sequential therapy, which involves appropriately utilizing currently available treatments rather than single therapies, is being proposed.

 

The American Society for Bone and Mineral Research (ASBMR) recommends sequential therapy as a treatment guideline, and the Korean Society for Bone Metabolism has also adopted similar guidelines.

 

“Treatment is essential for both high-risk and very high-risk fracture groups, but for those in the very high-risk category, considering initial treatment with bone-forming agents like Evenity or teriparatide can be an option,“ Professor Dempster said.

 

“Bone-forming agents have approved indications for a treatment duration of 1 to 2 years, so switching to bone resorption inhibitors like Prolia or bisphosphonate agents is recommended after a certain period of treatment.“ “Clinical studies like ARCH for Evenity and comparative studies of teriparatide with risedronate have confirmed that sequential therapy using bone-forming agents followed by bone resorption inhibitors provides more effective prevention against fractures in patients,“ he added.

 

Professor Dempster also expressed his hope that improvements in reimbursement criteria would shift awareness regarding osteoporosis treatment in South Korea.

 

Patients with chronic conditions such as hypertension and diabetes are well aware of their blood pressure or blood sugar levels and understand the need for lifelong medication.

 

However, understanding conditions like osteoporosis is notably lower, so individuals may not even realize they have osteoporosis.

 

“Korea is experiencing rapid aging, with an estimated half of the population expected to be 65 or older by 2070.

 

Therefore, starting osteoporosis treatment and reducing the risk of fractures through this treatment is crucial," he said.

 

"Instead of blaming patients for discontinuing treatment arbitrarily, verifying the reasons for discontinuation and appropriately explaining how significant and severe the consequences could be important,” Professor Dempster said.

 

“Efforts in the field, including expert persuasion of the government, have contributed to creating an environment for continuous treatment, even for patients with T-scores between -2.5 and -2.0.

 

Osteoporosis cannot be fully recovered, like lifelong diseases such as diabetes and hypertension, so management is currently the best approach.

 

I request that relevant government departments continue to listen to the voices of experts in the field,” Professor Dempster emphasized.