Osteoporosis new drugs same old lack of awareness
Published on 01 January 2009
Many new drugs to counter the worst effects of osteoporosis
are coming onto the market, yet for many older women it’s a struggle to get either a diagnosis or even basic treatment.
It’s an irony not lost on campaigning bodies and concerned clinicians that at a time when exciting new drugs for osteoporosis are more common than the proverbial No 53 bus, many women at serious risk of fracture remain undiagnosed and untreated.
In an ideal world, post-menopausal women considered to be likely to develop osteoporosis (risk factors include heavy smoking and drinking, family history, steroid use, and poor diet) would have a bone density scan known as DXA.
If the scan showed thinning bones they would be put on a bisphosphonate drug such as alendronate or risedronate, and offered calcium and Vitamin D to help to prevent or reduce further bone loss. Other, more expensive drugs would be available for those women who needed them.
However, numerous factors conspire to prevent this from happening. One major factor is a very poor level of awareness verging on downright ignorance about the significance of the condition – both among people with osteoporosis themselves and those who treat them.
This was recently thrown into sharp focus by the appearance of some worrying findings from a global study which revealed that 55 per cent of 60,000 women with osteoporosis did not believe they were at a greater risk of fracture than their healthy peers. Related research showed that less than half of osteoporosis patients were taking calcium and Vitamin D alongside their drug treatment – which is essential in order to get the maximum heath benefit.
These findings prompted Professor Cyrus Cooper, one of the investigators and a leading osteoporosis expert from the University of Southampton to comment that it was to be hoped that findings would highlight the deep impact that a fracture could have on a patient’s life. “It should create an awareness among health professionals that preventative therapy should be commenced urgently in patients with osteoporotic fractures,” he added.
Professor David Reid, a rheumatologist at Aberdeen University and another leading expert on osteoporosis, agrees that both patients and their doctors need to take osteoporosis much more seriously. “In Aberdeen we offer a DXA scan to anyone over the age of 50 who has had a fracture but a large proportion of people simply don’t turn up,” he says. “And whether or nor someone gets treated for osteoporosis depends very much on the will and the willingness of the GP. There’s very little financial incentive for them to do so.”
Rheumatologist at Salford Royal Hospital Dr Terry O’Neill says the system doesn’t abet swift diagnosis. He adds: “Many GPs lack awareness of osteoporosis, and a lot more needs to be done in terms of identifying the condition, and raising awareness of why it is so important.”
When a patient has a fracture they typically go to Accident and Emergency, may be referred to an orthopaedic surgeon, and then on to the fracture clinic. Continues Dr O’Neill: “Their details are processed but no-one realises that these patients then need to be “red-flagged” for their GP – in other words the GP doesn’t get a letter about their fracture so doesn’t put them on a bisphosphonate drug. Those hospitals that have a fracture liaison service can offer better more joined-up provision, but only 20- to 30 per cent of hospitals have this kind of service and large areas of the country don’t have it.”
Most vertebral fractures go undetected
The situation is equally gloomy for people whose osteoporosis causes a vertebral (spinal) fracture. According to Arthritis Research UK clinician scientist fellow at the University of Bristol, Dr Emma Clarke, up to 90 per cent of all vertebral fractures go undiagnosed. Because back pain is common, most GPs will not refer a patient with a possible fracture of the vertebrae for an x-ray or a scan and therefore the patient remains undiagnosed and without the treatment they need.
Another reason why osteoporosis is not always properly treated is the immensely complicated guidelines that cover both tried and tested and brand new drugs. Sensible, national guidelines that all medics understand and adhere would clearly be a big step forward but are currently lacking. Something that that has angered and frustrated campaigners in equal measure has been the failure over a six-year period of the government’s health watchdog body the National Centre for Health and Clinical Excellence (NICE) to produce what they regard as workable, ethical guidelines on the prescription of drugs for the primary prevention of osteoporosis. During this time, they point out, 420,000 people have suffered hip fractures, and 80,000 of whom will have died as a consequence.
According to the new NICE guidelines that were finally published in October 2008, patients at risk of fracture or who have had a fracture, may be prescribed alendronate, which is now off patent and in Professor Reid’s words is now: “cheap as chips, if not cheaper.” It costs between £50 and £108 a year, depending, if patients have a daily or weekly dose.
However, about a quarter of patients are unable to tolerate alendronate, which can result in unpleasant gastro-intestinal side effects, or it simply doesn’t work for them. But although the guidelines allow patients to switch to another bisphosphonate, such as risedronate or etidronate (both slightly more expensive) it is on the basis of a list of complex criteria involving a patient’s age, bone density, risk factors and fragile bone indicators that the average GP or patient would find completely baffling and largely incomprehensible.
“Unworkable” NICE guidance
This has enraged the National Osteoporosis Society, which led an unsuccessful appeal against the NICE guidance on the basis that the guidelines effectively mean that patients’ bone density has to worsen before they can access a second bisphosphonate.
Health sector relations officer with the NOS Anne Thurston says: “We’re very unsatisfied with the guidance which states that you have to get worse before you get better – it flies in the face of medical practice and is unworkable. We are talking about everyday GPs in their surgeries, not experts in osteoporosis, trying to make the best judgments they can. We know awareness of osteoporosis is not what it should be, and having unclear guidelines does not help.”
David Reid goes further: “The current clinical guidelines are not only clinically unworkable but I think they encourage doctors to go against the Hippocratic Oath to do the best for their patients. It’s bad practice and complete and utter nonsense – and it’s purely about costs.”
In anger and frustration at the NICE guidelines, Professor Reid and other experts within the National Osteoporosis Guidelines Group have drawn up their up own guidelines, aimed at improving the assessment of fracture risk ad to identify the most appropriate treatment. They are using an online fracture risk assessment called FRAX developed by the World Health Organisation that can be used by interested GPs which has guidelines on the treatment of men and pre-menopausal women, and includes some the newer treatments for osteoporosis. But again, it depends on the willingness of GPS to use it.
Meanwhile the NOS will continue to lobby for a new NICE appraisal of new and existing drugs in 2010.
So is there any light on the horizon for the thousands of people with osteoporosis at real risk of fracture? One small chink appears to be the decision to include osteoporosis in the GP contact as a new Directed Enhanced Service (DES) This means that GPs will be paid extra to diagnose and treat patients with osteoporosis. However, the relatively small amount of money allocated to the DES (£5m this year and £5m in 2010; just £588 per year per GP practice) will limit its effectiveness.
Every year there are more than 230,000 fractures due to osteoporosis, with 70,000 hip fractures, 50,000 wrist fractures and 120,000 vertebral fractures.
The combined cost of hospital and social care for patients with a hip fracture is more than £1.73bn.
Generic alendronate costs between £53 (for a once weekly dose) and £100 a year (a once daily dose). Etidronate costs £85 a year, and risedronate (Actonel) between £250 and £265 a year.
New osteoporosis drugs in the pipeline: denusomab, a promising biologic agent which appears to be at least as effective as another recent addition to the market, zoledronic acid (brand names Aclasta and Zometa). Slightly further on the horizon is odanacitab, currently undergoing Phase II trials.
How research is helping
The situation may improve in the medium to long-term if a major clinical trial funded largely by the Medical Research Council, with additional support from Arthritis Research UK, shows that mass screening of women over the age of 70 – through a combination of self-reported risk factors and a bone scan can help to reduce the numbers who suffer fractures. Importantly, it will also assess if screening is cost effective. The SCOOP trial started in January 2008 and will run for seven years.
An earlier Arthritis Research UK-funded pilot study indicated that a systematic, community-based approach to screening older women for the disease could be effective.
Several other Arthritis Research UK-funded research projects may also lead to more efficient means of detecting the condition.
A team led by Professor Tim Cootes at the University of Manchester’s Imaging Science and Biomedial Engineering Research Division is aiming to devise a quicker and more accurate means of identifying vertebral fracture and diagnosing osteoporosis than the current DXA screening. The new diagnostic tool is a computer programme which will be able to detect each vertebra in each x-ray and DXA image, and indicate whether it is fractured a how badly.
Dr Clarke in Bristol is using her three year Arthritis Research UK fellowship to recruit up to 4,000 women between the ages of 65 and 80 to take part in a screening programme to detect vertebral fractures by having a simple x-ray. She hopes that if it is proven to be clinically and cost effective, it could lead to a big change in the way older women are treated nationally by GPs.
With his three-year clinician scientist fellowship from Arthritis Research UK, Dr Ken Poole at Addenbrooke’s Hospital in Cambridge hopes to develop new methods of assessing and preventing thinning of bones in the neck of the femur, using new high resolution scanning techniques called CT scans.
Dr Poole is all too aware of the devastating consequences that a hip fracture can cause in older women, and which so easily could be avoided. He adds: “Hip fractures in older adults annually account for more than 85,000 hospital admissions, and up to a third of sufferers die within a year, with survivors facing pain, reduced mobility and lack of independence.”
Read the Arthritis Research UK booklet on osteoporosis or call 0870 8505000.
NOS helpline can be contacted on 0845 450 0230.
The FRAX guidelines can be accessed here www.shef.ac.uk/FRAX
NICE patient guidelines on osteoporosis can be accessed at http://www.nice.org.uk/nicemedia/pdf/TA160publicinfo.pdf