News
Thousands of menopausal women in England to benefit from bone-strengthening drug
Thousands of menopausal women in England could benefit from a new drug that helps prevent bone fractures.
Bone density declines rapidly after menopause, because of a decrease in the levels of oestrogen. This thinning of bone density known as osteoporosis and can increase the risk of bone fractures.
In England and Wales, more than two million women suffer from osteoporosis. The condition is linked to more than half a million fractures a year in UK, at a cost of more than £4.5bn.
Abaloparatide, a daily at-home injection, has been approved for NHS use by the National Institute for Health and Care Excellence (NICE).
The drug, sold as Eladynos and made by Theramex, increases bone density by stimulating the cells that make new bones. It has been recommended for patients at high risk of bone fractures, with Nice estimating that it could benefit more than 14,000 women who have gone through menopause.
“The independent committee heard from patients about how debilitating osteoporosis can be and how it impacts all aspects of day-to-day life, such as not going out for a walk because they are fearful of falling and having a fracture,” said Jonathan Benger, chief medical officer and deputy chief executive of Nice.
“This can impair mental and physical health. Our focus is on enabling access to care that improves quality of life while offering value to the taxpayer.
“Abaloparatide has been found by our independent committee to be clinically and cost effective at reducing the risk of fracture, giving people more independence and, therefore, a better quality of life.”
Craig Jones, chief executive of the Royal Osteoporosis Society, said: “Considering that half of women over 50 will suffer broken bones due to osteoporosis, and the extent of disability these breaks cause, the paucity of new treatments over the last decade and a half has been a huge cause for concern.
“We are very pleased that Nice have recommended a new drug treatment for postmenopausal women at the greatest risk of breaking bones. This will change many thousands of lives for the better and we’re looking forward to seeing the impact it makes in communities across the country.”
Prof Kamila Hawthorne, chair of the Royal College of GPs, added: “GPs will always do our best to develop a treatment plan with patients based on all the various factors impacting on their health – and sometimes first line treatments won’t be appropriate or effective – so it’s positive to see a new treatment option has been approved by Nice for us to consider.
“We hope that this will help patients who have osteoporosis but have not responded to other treatments.”
Abaloparatide will be available to eligible patients on the NHS within three months.
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Hormonal health
Topical HRT protects bone density in women with period loss – study
Transdermal HRT best protects bone density in women with functional hypothalamic amenorrhoea, a condition that stops periods, a review of trials has found.
The meta-analysis pooled randomised clinical trials involving 692 participants and found transdermal hormone replacement therapy and teriparatide increased bone mineral density by between 2 and 13 per cent.
Functional hypothalamic amenorrhoea can follow anorexia or intense exercise. Bone mineral density measures bone strength and the amount of mineral in bone.
Around half of women with the condition have low bone mineral density, compared with about 1 per cent of healthy women, and their fracture risk is up to seven times higher.
The research was conducted by scientists at Imperial College London and Imperial College Healthcare NHS Trust.
Professor Alexander Comninos, senior author of the study and consultant endocrinologist at the trust, said: “Bone density is lost very rapidly in FHA and so addressing bone health early is very important to reduce the lifelong risk of fractures.
“Our study provides much needed comparisons of all the available treatments from all available studies.
“Clearly the best treatment is to restore normal menstrual cycles and therefore oestrogen levels through various psychological, nutritional or exercise interventions – but that is not always possible.
“The foundation for bone health is good calcium and vitamin D intake (through diet and/or supplements) but we have additional treatments that are more effective.”
When FHA is diagnosed, clinicians first try to restore periods through lifestyle measures, including psychological and dietary support, but these can fail. Guidelines then recommend giving oestrogen, though the best form was unclear.
The team reviewed all prior randomised trials comparing therapies, including oral and transdermal oestrogen, and also assessed teriparatide, a prescription bone-building drug used for severe osteoporosis.
They found no significant benefit for oral contraceptive pills or oral hormone therapy.
A recent UK audit reported that about a quarter of women with anorexia-related FHA are prescribed the oral contraceptive pill for bone loss; the study suggests using transdermal therapy instead.
Comninos said: “Our goal is simple: to help women receive the right treatment sooner and to protect their bone health in the long-term.
“We hope this study provides clinicians with better evidence to choose transdermal oestrogen when prescribing oestrogen and so inform future practice guidelines.
“Right now, millions of women with FHA may not be receiving the best treatments for their bone health.”
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