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Can Evenity Really Build New Bones? Understanding the Science of Romosozumab

4 min read

According to the National Osteoporosis Foundation, approximately 80% of patients who have had an osteoporotic fracture are not identified or treated. In contrast to many osteoporosis drugs that only slow down bone loss, Evenity is a treatment that actively helps the body build new bones. This article delves into the specific mechanism that allows it to rebuild bone mass and helps you understand its role in treating severe osteoporosis.

Quick Summary

Evenity (romosozumab) is a unique osteoporosis medication that builds new bone and decreases bone loss by inhibiting the protein sclerostin. This dual effect leads to significant bone mineral density increases over 12 months, reducing the risk of fractures. Treatment duration is limited, requiring follow-up therapy to maintain bone gains.

Key Points

  • Dual-Action Mechanism: Evenity is unique because it both builds new bone and reduces bone loss, unlike many other osteoporosis drugs.

  • Blocks Sclerostin: The medication works by inhibiting the protein sclerostin, which naturally suppresses bone formation.

  • Significant Bone Gains: Clinical trials show Evenity causes rapid and substantial increases in bone mineral density at the spine and hip within 12 months.

  • Limited Treatment Duration: Evenity is prescribed for a fixed duration of 12 monthly doses, after which the bone-building effect diminishes.

  • Essential Follow-Up Therapy: After completing Evenity, patients must transition to an anti-resorptive medication to maintain the bone mineral density gains.

  • Cardiovascular Risk: Evenity carries a boxed warning due to an increased risk of heart attack, stroke, and cardiovascular death, particularly in patients with a history of these events.

  • Targeted Population: It is typically used for postmenopausal women with severe osteoporosis who are at very high risk of fracture.

In This Article

Understanding Evenity's Dual-Action Mechanism

Evenity, with the active ingredient romosozumab, is a monoclonal antibody that targets and inhibits a protein called sclerostin. Unlike traditional antiresorptive medications that focus solely on slowing bone breakdown, Evenity employs a unique "dual effect". By blocking sclerostin, it increases the activity of bone-forming cells (osteoblasts) while simultaneously reducing the activity of bone-resorbing cells (osteoclasts). This results in a rapid and substantial increase in bone mineral density (BMD).

The Role of Sclerostin

Sclerostin is a protein naturally produced by osteocytes, the most abundant type of cell in bone tissue. It acts as a negative regulator of bone formation, essentially putting a brake on the process. In healthy individuals, sclerostin helps maintain a balanced cycle of bone formation and resorption. However, in people with osteoporosis, this balance is disrupted, leading to excessive bone loss. Evenity's mechanism of action directly addresses this imbalance by taking the brake off of bone formation, allowing for a concentrated period of new bone building.

Clinical Evidence for Bone Building

Clinical trials have demonstrated Evenity's significant ability to build new bone. In the FRAME study, postmenopausal women with osteoporosis who received Evenity for 12 months showed a rapid and significant increase in BMD compared to those on a placebo. Specifically, after 12 months of treatment, patients on Evenity had a 12.7% increase in lumbar spine BMD and a 5.8% increase in total hip BMD. These gains were followed by further improvements in the second year when patients transitioned to another anti-resorptive therapy like denosumab.

Evenity vs. Other Osteoporosis Treatments

To understand the distinct role of Evenity, it's helpful to compare its bone-building mechanism with other common osteoporosis medications.

Feature Evenity (Romosozumab) Bisphosphonates (e.g., Alendronate) PTH Analogs (e.g., Tymlos, Forteo)
Mechanism Dual-action: Increases bone formation and decreases resorption. Antiresorptive: Primarily slows down bone loss. Anabolic: Stimulates bone formation, but also increases resorption.
Effect on Bone Builds new, high-quality bone, increasing density rapidly. Preserves existing bone density over time by reducing bone turnover. Stimulates bone-forming cells to make new bone.
Administration Monthly subcutaneous injections for 12 months. Daily, weekly, or monthly oral tablets, or yearly IV infusion. Daily subcutaneous injections for up to 2 years.
Duration Limited to 12 monthly doses. Chronic treatment, often for several years. Limited to 1-2 years of use.
Follow-up Therapy Mandatory follow-up with an anti-resorptive agent is required to maintain bone gains. Treatment may be followed by a "drug holiday" or continued therapy based on risk assessment. Followed by an anti-resorptive to maintain gains.

The Treatment Course and Importance of Follow-Up

The full course of Evenity therapy consists of 12 monthly injections administered by a healthcare provider. Because the bone-building effect wanes after one year, it is crucial to transition to a subsequent anti-resorptive agent to maintain the newly built bone mass and fracture risk reduction. In clinical trials, patients who transitioned to an anti-resorptive like alendronate or denosumab maintained or even further increased their bone mineral density over the following year or two. Without this follow-up therapy, the gains in bone density may regress.

Who is Evenity For?

Evenity is specifically approved for postmenopausal women with osteoporosis who are at high risk for fractures. This includes those with a history of osteoporotic fractures, multiple risk factors for fracture, or those who have failed or are intolerant to other therapies. Due to its significant side effect profile, particularly the boxed warning regarding an increased risk of heart attack, stroke, and cardiovascular death, it is not recommended for patients who have had a heart attack or stroke in the preceding year. A thorough discussion of risks and benefits with a healthcare provider is essential.

Evenity in Clinical Practice

For patients requiring a rapid and robust increase in bone density, Evenity can be a powerful tool. Some patients who previously struggled to build bone mass have reported feeling stronger and less pain after treatment. For example, a patient on Drugs.com shared, "I had a total hip replacement... my surgeon said my bones were so much stronger that it was hard as stone. He was well pleased with Evenity". However, patient experiences vary, and some report side effects such as joint pain, headaches, or flu-like symptoms. It is crucial for patients to report any unusual symptoms to their doctor promptly.

Conclusion

Yes, Evenity can truly build new bones. It functions as a powerful anabolic agent, leveraging a dual-action mechanism that increases new bone formation while simultaneously decreasing bone resorption by inhibiting sclerostin. Clinical trials have shown its ability to significantly increase bone mineral density and reduce fracture risk in postmenopausal women with severe osteoporosis. However, it is a specialized, short-term treatment requiring a follow-up anti-resorptive to preserve the bone gains. While effective for high-risk individuals, it comes with important cardiovascular warnings that necessitate careful consideration and a thorough consultation with a healthcare provider.

Frequently Asked Questions

Evenity (romosozumab) builds new bone by inhibiting the protein sclerostin, which normally suppresses bone formation. By blocking sclerostin, Evenity stimulates osteoblasts (bone-building cells) to create new bone tissue, while also slightly reducing the activity of osteoclasts (bone-resorbing cells).

Evenity works rapidly, with a significant increase in bone mineral density (BMD) observed within the first 12 months of treatment. Clinical trials have shown substantial BMD increases at the spine, hip, and femoral neck after just one year.

No, Evenity is a short-term treatment limited to 12 monthly doses. After completing the one-year course, the patient must transition to a different anti-resorptive osteoporosis medication to maintain the bone mineral density gains achieved.

After completing the 12-month Evenity course, your doctor will likely prescribe a different anti-resorptive medication, such as a bisphosphonate or denosumab. This follow-up therapy is necessary to maintain the improved bone density and fracture risk reduction.

Evenity carries a boxed warning for an increased risk of heart attack, stroke, and cardiovascular death. Other serious risks include osteonecrosis of the jaw and unusual femur fractures. It is not recommended for patients with a history of heart attack or stroke within the past year.

Evenity is approved for postmenopausal women with severe osteoporosis who are at high risk for fracture. This includes those with a history of osteoporotic fractures or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.

Evenity was initially approved for postmenopausal women at high risk for fracture. While one clinical study evaluated its safety and efficacy in men, the specific FDA indication and fracture risk reduction data are primarily based on trials in women.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice. Always consult a qualified healthcare provider regarding personal health decisions.