We are pleased that a new osteoporosis medication called romosozumab, used to treat post-menopausal women at high risk of breaking a bone, has been approved by the European Medicines Agency (EMA). Romosuzumab – sold under the brand name EVENITY® – is a bone-building drug that not only increases bone formation but to a lesser extent reduces bone loss. However, it may not be suitable for people with a history of heart attacks or strokes. The Food and Drug Administration (FDA) approved the medication in the US back in April after safety and efficacy data from two clinical trials, involving more than 11,000 women with post-menopausal osteoporosis, showed that it could lower the risk of a new spinal fracture by 73%. The use of the medication in the UK was initially denied in June due to concerns about why the medicine appeared to increase the risk of heart and circulatory problems. However, the EMA has now decided to give regulatory approval for romosozumab following an appeal, provided that its use is restricted to women with no history of heart attack and stroke. The EMA said: “The Agency finally concluded that if restricted in this way, the benefits of Evenity would outweigh its risks in postmenopausal women with severe osteoporosis who are at a high risk of fracture. Additional measures and studies are foreseen to follow its use in practice and to ensure that the medicine is used correctly.” Given that osteoporosis causes one in two women to experience a fracture in her lifetime, UK approval of the medicine is very positive and means that healthcare professionals and patients will have more choice in clinically effective osteoporosis treatments. Alison Doyle, our head of clinical practice and operations, says: “We welcome the approval of this highly effective drug. It is important to remember that, as with any medication, there are side effects that need to be considered and romosozumab may not be suitable for everyone. However, it is a highly effective drug that will benefit many people. "It has taken 15 years of research to get to this point, and it’s been nine years since the last osteoporosis drug was approved. With no other new treatments on the horizon, this really is a positive step and provides improved patient choice.” She adds: “Drugs aren’t the only solution though. We also need to better understand the causes of osteoporosis, which is why our Osteoporosis and Bone Research Academy is working with patients, research clinicians and academics in the field to advance our knowledge and ultimately find a cure for osteoporosis.” The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A decision by the EC is expected by the end of the year.
Over 100 NHS clinicians have called on the National Institute for Health and Care Excellence (NICE) to change course over its decision to decline to recommend romosozumab, the first new drug for severe osteoporosis for over a decade. In a joint letter published on Sunday 2 January, the clinicians warn of the consequences of barring access to the drug to women who suffer a severe form of the bone-weakening disease. Half of women over 50, and one-fifth of men, will suffer fractures (broken bones) due to osteoporosis. Fractures are one of the most urgent threats to living well in later life, undermining quality of life and independence. As many people die of fracture-related causes as from lung cancer, diabetes or chronic lower respiratory diseases. Romosuzumab is already transforming the lives of women with severe osteoporosis in Scotland, Northern Ireland and much of Europe. This new treatment prevents fractures by stimulating bone formation, as well as reducing bone loss, and would offer much-needed hope and relief for patients living in England and Wales. The joint letter, led by the Royal Osteoporosis Society (ROS), raises alarm over the lightness of the drug pipeline for osteoporosis, as well as a lack of public funding for new research. Recent figures from Government showed the National Institute for Health Research (NIHR) invested less than £1m in osteoporosis research in 2020-1 – a figure which pales in comparison with the £4.6bn per year cost to the NHS of fractures – and which bodes ill for the development of further such innovative treatments. Craig Jones, Chief Executive of the Royal Osteoporosis Society said: The provisional decision from NICE is under consultation, pending a hearing scheduled for early in 2022. The joint letter Sir/Madam, We write as a group of 100 clinicians operating in one of the most under-served fields in the NHS: osteoporosis and bone health. Half of women over the age of 50 – and one-fifth of men - will break a bone due to osteoporosis, causing long-term pain, disability and loss of independence. The condition is one of the most urgent threats to living well in later life. Mercifully, osteoporosis is treatable, given the right therapies. That’s why we’re troubled by the decision of the National Institute for Health and Care Excellence (NICE) to decline to recommend use of the first new osteoporosis medication for over a decade. With a drugs pipeline that’s historically light, and chronically underfunded public research, women with severe osteoporosis deserve the chance to benefit from this innovative new treatment. Romosozumab is one of only two treatments licensed by MHRA which induces new bone formation, and the first in this category to simultaneously reduce bone loss. It is highly effective in reducing the risk of fracture and will provide relief and hope to women who are at very high risk of fractures. This medication is already approved for use in Scotland and Northern Ireland, as well as much of Europe. To deny access to patients in England and Wales will worsen health inequalities across the four nations. Women’s health is already beset by structural inequalities which run deep across society. We must make sure the benefits of scientific breakthroughs are made available to everyone who needs them, no matter where they live. Medically Reviewed by David Zelman, MD on August 04, 2022 Osteoporosis medications improve your bone mineral density and prevent fractures. Some osteoporosis meds help you build more bone, while others slow the loss of bone. As you get older, your bones may start to wear down faster than your body can repair them. If you lose a lot of bone density, the doctor could diagnose you with osteoporosis. Osteoporosis can’t be cured, but with medicine and lifestyle changes, you can slow or even stop it. Regular exercise, a diet rich in calcium and vitamin D, and prevention of falls can all make a difference. But they aren’t always enough. That’s why the doctor may suggest medicine. When it comes to osteoporosis meds, you have a lot of options, so it helps to know the landscape. The doctor will suggest a prescription medication partly based on how severe your osteoporosis is. But that isn’t the only thing they’ll consider. What you take will also depend on: Osteoporosis drugs are grouped into two categories: Some osteoporosis drugs fall into both categories. The medication your doctor suggests depends on many things including whether they are preventing or treating your osteoporosis as well as other medical conditions you have. Not all osteoporosis drugs are FDA-approved for all people with osteoporosis. For example, a drug approved to treat osteoporosis in postmenopausal women may not be approved for treating osteoporosis in men. Talk to the doctor about your specific medication and whether or not it’s approved or being used off-label. This is the most commonly used class of medicines to treat osteoporosis in men and women. They work by slowing the rate of bone loss. The main bisphosphonates are: Will I ever stop taking them? Check with your doctor regularly to see how your meds are working. If you do well on them for up to 5 years -- no fractures and your bone density is steady -- your doctor may suggest you take a break. These medications stay in your body for a while after you stop taking them. That means you’ll still get some benefit even after you’re off them. Side effects: For the pills, the most common ones are:
If you take the pills exactly as directed, you’re less likely to have problems. With the IV meds, you may get fever, headache, and muscle aches for up to 3 days. It’s rare, but both the pills and the IV may cause two other issues:
If you’re highly likely to have a fracture, your doctor may suggest denosumab (Prolia, Xgeva). You might also get it when bisphosphonates either didn’t work well enough or couldn’t be used for some reason. Depending on which medicine you’re on, you’ll get this as a shot every 1-6 months. Will I ever stop taking it? There’s no hard and fast rule for how long you can take this medication. It doesn’t stick around in your body like bisphosphonates do. It’s best to see your doctor regularly to check how well it’s working and if you have any side effects. Side effects: Denosumab may lower the amount of calcium in your body, so it’s important that your calcium and vitamin D levels are high enough before you start taking it. It may also make you more likely to get infections, especially on your skin. Call your doctor if you get: Other common side effects include: This monoclonal antibody is among the newest drugs to be FDA-approved for treating postmenopausal osteoporosis. It blocks a protein called sclerostin, which controls bone turnover. The dual-acting type of osteoporosis medication helps build bone while reducing bone density loss. You get it as a shot. Joint pain and headaches are common side effects. Romosozumab may also increase the risk of heart attack, stroke, and death. Don’t take this drug if you’ve had a heart attack or stroke within the previous year. Hormones can be used to treat osteoporosis, but some have serious side effects. Parathyroid hormone. Given as abaloparatide (Tymlos) or teriparatide (Forteo), it grows bone. It’s used mostly if you have very low bone density and you’ve already had fractures. It comes as a shot that you need to get every day. You’ll take it for 2 years at most. Then, you’ll switch to a different medication to help maintain the added bone. Common side effects include dizziness, headaches, and feeling like you might throw up. Calcitonin(Miacalcin). This hormone comes as a spray or a shot. It’s only for women who are at least 5 years past menopause. It helps reduce spine fractures, but it doesn’t help with other bones. Because calcitonin may be linked to cancer, the FDA recommends it only when other treatments can’t be used. Research shows that calcitonin doesn’t prevent non-spinal bone fractures as well as bisphosphonates or denosumab. Estrogen. While estrogen, another hormone, can help with osteoporosis in women who have been through menopause, it also has serious side effects, such as: Because of this, the FDA suggests taking only the smallest dose for the shortest possible time and only if you’re highly likely to get fractures. SERMs. Short for selective estrogen receptor modules, these offer similar benefits to estrogen without some of the serious side effects. The SERM raloxifene (Evista) may even lower the chances you’ll get breast cancer. But it still may lead to blood clots and stroke. Your doctor can help you weigh the pros and cons of these medications. |
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