The Silent Epidemic: Understanding Osteoporosis and Fracture Risk
Osteoporosis is a widespread condition characterized by reduced bone density and quality, leading to fragile bones that are highly susceptible to fractures [1.6.6]. Often called a "silent disease," many individuals are unaware they have it until they experience a break from a minor fall or even a simple cough [1.4.5, 1.6.6]. The statistics in the United Kingdom are stark: an estimated 3.5 million people are affected, leading to over 500,000 fragility fractures annually [1.6.1, 1.6.3]. These fractures, particularly of the hip and spine, can cause significant pain, long-term disability, loss of independence, and are associated with increased mortality [1.4.4, 1.6.5].
For postmenopausal women, the risk is especially high due to the decrease in estrogen, a hormone crucial for maintaining bone strength [1.2.1]. Half of all women over 50 are expected to suffer an osteoporotic fracture in their lifetime [1.6.3]. This significant public health challenge underscores the urgent need for effective treatments to strengthen bones and prevent debilitating fractures. The National Institute for Health and Care Excellence (NICE) plays a pivotal role in evaluating and recommending new, clinically effective, and cost-effective treatments for use within the NHS.
A New Era in Bone-Building: Abaloparatide (Eladynos) Gains NICE Approval
In a significant development for osteoporosis management, NICE issued guidance in August 2024 recommending abaloparatide (marketed as Eladynos by Theramex) for treating osteoporosis in postmenopausal women at very high risk of fracture [1.2.1, 1.4.2]. This approval introduces a vital new option for a specific patient group that needs it most.
NICE's recommendation is for individuals who have a very high fracture risk, providing an alternative for those who cannot tolerate or have not responded to other treatments [1.2.1]. It is estimated that over 14,000 women in England could benefit from this new therapy [1.2.1, 1.4.6]. The drug is positioned as an alternative to other anabolic agents like teriparatide and romosozumab [1.4.4].
How Abaloparatide Works: Stimulating New Bone Formation
Osteoporosis treatments are broadly categorized into two types: antiresorptive and anabolic agents [1.4.9].
- Antiresorptive drugs, such as bisphosphonates (e.g., alendronic acid), work by slowing down the rate at which old bone is broken down [1.2.2].
- Anabolic (bone-forming) drugs actively stimulate the cells that build new bone (osteoblasts), thereby increasing bone mass and improving its structure [1.2.2, 1.4.9].
Abaloparatide falls into the anabolic category. It is a synthetic peptide that works by activating the parathyroid hormone 1 (PTH1) receptor, which stimulates osteoblast activity and promotes new bone formation [1.2.2, 1.4.3]. This mechanism helps to strengthen bones from the inside out, making them more resilient and less likely to break [1.4.5].
Treatment with abaloparatide is administered as a daily subcutaneous (under the skin) injection using a pre-filled pen, which can be self-administered at home [1.2.1]. The treatment course is limited to a maximum of 18 months. Following the completion of abaloparatide therapy, patients typically transition to an antiresorptive medication, like a bisphosphonate, to preserve the bone density gains achieved [1.4.7, 1.4.9].
Comparing Osteoporosis Anabolic Treatments
With the approval of abaloparatide, clinicians and patients now have another choice among anabolic agents. Understanding the differences is key to making an informed treatment decision.
| Feature | Abaloparatide (Eladynos) | Teriparatide (Forteo) | Romosozumab (Evenity) |
|---|---|---|---|
| Mechanism | Anabolic: PTH1 receptor activator, stimulates bone formation [1.2.2, 1.4.3]. | Anabolic: Parathyroid hormone analogue, stimulates bone formation [1.2.7]. | Dual Effect: Sclerostin inhibitor, increases bone formation and decreases bone resorption [1.2.7, 1.3.1]. |
| Administration | Daily subcutaneous injection [1.2.1]. | Daily subcutaneous injection [1.2.7]. | Monthly subcutaneous injections (two separate injections) [1.2.7, 1.3.7]. |
| Treatment Duration | Up to 18 months [1.4.9]. | Up to 24 months [1.4.9]. | Up to 12 months [1.4.9]. |
| Key Considerations | Does not require refrigeration after first use of each pen [1.4.9]. Lower risk of hypercalcemia than teriparatide [1.4.9]. | Requires refrigeration, which can be a barrier for travel [1.4.9, 1.5.1]. | Not recommended for patients with a history of heart attack or stroke [1.4.9, 1.5.1]. |
| Follow-up Therapy | An antiresorptive agent (e.g., bisphosphonate) is started after treatment to maintain bone gains [1.4.9]. | An antiresorptive agent is started after treatment [1.2.7]. | An antiresorptive agent is started after treatment [1.2.4]. |
Clinical Efficacy and Safety
The approval of abaloparatide was based on robust clinical evidence, primarily from the ACTIVE trial [1.4.4]. This study demonstrated that abaloparatide significantly reduces the risk of fractures compared to placebo. When followed by alendronic acid, abaloparatide showed an 84% lower risk of new vertebral fractures compared to those who took a placebo followed by alendronic acid [1.4.9].
Indirect comparisons suggest abaloparatide's efficacy is at least as good as teriparatide and romosozumab [1.4.1, 1.4.4]. Importantly, patient experts highlighted that the risk of certain side effects can be a major concern with existing treatments. The ACTIVE trial data for abaloparatide noted a lower risk of hypercalcemia (high blood calcium) compared to teriparatide and no observed episodes of osteonecrosis of the jaw, a rare but serious side effect linked to some other osteoporosis drugs [1.4.9].
Conclusion: A Welcome Addition to Osteoporosis Care
The NICE recommendation for abaloparatide (Eladynos) marks a welcome advancement in the treatment of severe osteoporosis for postmenopausal women at very high fracture risk [1.2.3, 1.4.8]. By stimulating new bone formation, it offers an effective alternative that can help strengthen bones, reduce the risk of life-altering fractures, and improve quality of life [1.2.1]. Its at-home administration and distinct safety profile provide a valuable new option for clinicians to discuss with patients, ensuring treatment plans can be better tailored to individual needs and circumstances. As it becomes available on the NHS, abaloparatide is set to play an important role in the fight against osteoporosis-related fractures.
For more information, consult the official guidance on the NICE website.
