Latest Developments in Osteoporosis Treatment
While the search for a new oral pill for osteoporosis is ongoing, the most recent FDA-approved therapies are not pills but injectable medications designed for high-risk patients. The approval of romosozumab (Evenity) in 2019 and denosumab biosimilars in 2025 represents significant progress in the field. These innovations offer new mechanisms of action or more cost-effective alternatives to help reduce fracture risk and increase bone mineral density.
Romosozumab (Evenity): A Dual-Action Injectable
Romosozumab, marketed as Evenity, was approved by the FDA in 2019 for treating postmenopausal women with severe osteoporosis at high risk of fracture. Its unique mechanism of action sets it apart from many older therapies. It is a monoclonal antibody that targets sclerostin, a protein that inhibits bone formation. By blocking sclerostin, Evenity simultaneously stimulates new bone growth and, to a lesser extent, reduces bone breakdown.
Unlike many long-term medications, Evenity is administered as a monthly injection for a limited duration of 12 months. After completing the one-year course, patients transition to an antiresorptive medication, such as a bisphosphonate or denosumab, to maintain the bone mineral density gains. This approach leverages the anabolic (bone-building) effect of Evenity to rapidly improve bone density, followed by a maintenance phase with other drugs.
Denosumab Biosimilars: Accessible Injectable Alternatives
In 2025, the FDA approved biosimilars referencing denosumab, the active ingredient in Prolia and Xgeva. Biosimilars, such as Stoboclo and Osenvelt, are highly similar to existing biologic medications but offer the potential for significant cost savings. Denosumab is a monoclonal antibody that works differently from Evenity by inhibiting a protein called RANKL, which is crucial for the formation and function of osteoclasts (the cells that break down bone).
These biosimilars, delivered via subcutaneous injection every six months, expand access to an effective antiresorptive treatment. This is particularly important for patients who cannot take oral medications due to gastrointestinal issues or other contraindications. The availability of these biosimilars adds more choices and competitive pricing to the market for a widely used therapy.
The Search for the New Oral Pill: What's in the Pipeline?
While injectable therapies have dominated the latest approvals, research and development continue for new, convenient oral medications that could change the landscape of osteoporosis treatment. Promising candidates are currently undergoing clinical trials:
- EB613 (Entera Bio): This experimental drug is an oral formulation of human parathyroid hormone (PTH). In Phase 2 clinical trials, it met primary endpoints for increasing bone mineral density (BMD) at key skeletal sites, positioning it as a potential first-in-class oral anabolic agent. A pill that builds bone, rather than just preventing bone loss, would be a major innovation.
- NaQuinate (Haoma Medica): This is another novel therapeutic with a different mechanism of action designed for low-dose oral administration. It has completed Phase 1 studies and is progressing toward Phase 2 trials.
- SK-124 (Massachusetts General Hospital): Researchers developed an oral compound that influences the PTH signaling pathway. In mouse models, it successfully increased bone formation and bone mass. Further development and optimization are underway to make it a viable treatment for patients.
Comparison of New and Existing Osteoporosis Treatments
| Medication | Class/Mechanism | Delivery Method | Key Benefit | Key Consideration |
|---|---|---|---|---|
| Romosozumab (Evenity) | Sclerostin Inhibitor (Dual Action) | Monthly Injection (12 months) | Rapidly builds new bone and reduces resorption | Black box warning for cardiovascular risk; short-term use requiring follow-on therapy |
| Denosumab & Biosimilars (Prolia, Stoboclo) | RANKL Inhibitor (Antiresorptive) | Subcutaneous Injection (every 6 months) | Strong efficacy in reducing fractures; option for those intolerant of bisphosphonates | Bone loss rebound risk upon discontinuation; requires lifelong therapy or transition |
| Bisphosphonates (Alendronate, Risedronate) | Antiresorptive | Oral (daily/weekly/monthly) or IV (yearly) | Cost-effective and widely available; proven long-term efficacy | Potential gastrointestinal side effects; specific dosing instructions required |
| Teriparatide (Forteo) | PTH Analog (Anabolic) | Daily Self-Injection (up to 2 years) | Actively builds new bone, excellent for severe cases | High cost; limited duration of use |
| EB613 (Experimental) | Oral PTH Analog (Anabolic) | Oral Pill (in development) | Potential for the first oral bone-building therapy | Still in clinical trials; not yet available to the public |
Key Considerations for Treatment
Choosing the right osteoporosis medication depends on several factors, including the severity of the disease, risk factors, and patient preference. For high-risk individuals, the potent bone-building effects of Evenity may be a first-line consideration. However, its cardiovascular risk profile must be carefully evaluated. Injectable therapies like denosumab and its new biosimilars offer effective, long-lasting options, especially for those unable to take oral medications. For many, long-standing and cost-effective oral bisphosphonates remain a standard first-line treatment.
The ongoing research into new oral compounds like EB613 is promising for those who prefer the convenience of a pill but require anabolic, bone-building therapy. Until these come to market, a comprehensive discussion with a healthcare provider about all available options, delivery methods, and individual risk factors is crucial. Ultimately, a treatment plan combines medication, adequate calcium and vitamin D intake, and lifestyle modifications like weight-bearing exercise to manage osteoporosis effectively.
Visit the National Institutes of Health for more information on osteoporosis research.
Conclusion: Navigating Osteoporosis Treatments in the Modern Era
The landscape of osteoporosis medication is continually evolving, with recent advancements focusing on powerful injectable treatments rather than new oral pills. Romosozumab (Evenity) offers a unique, short-term bone-building option for high-risk patients, while the approval of denosumab biosimilars enhances accessibility to a proven antiresorptive therapy. The future holds promise for innovative oral medications, with candidates like EB613 showing positive results in clinical trials. As a result, patients and healthcare providers must stay informed about the varying mechanisms, delivery methods, and risk profiles of all available and emerging options to choose the most effective treatment plan for their individual needs.
