Category Archives: Endocrinology

Amazon sells exclusive diabetes and hypertension devices

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Amazon has launched an exclusive range of medical devices to help people manage their diabetes and hypertension at home.

The Choice devices, produced by the healthcare consultancy, Arcadia Group – which is not affiliated with the British fashion brand of the same name –include blood glucose monitors, blood pressure monitors and test strips.

Choice estimates that diabetes and hypertension affect up to 130 million Americans and hopes that its devices will help those afflicted to benefit from daily monitoring and progress tracking over time.

Conventional models and devices enabled with Bluetooth connectivity features will be available to buy, with pricing said to offer better value over devices that can be bought in pharmacies, according to the company.

Bob Guest, CEO of Arcadia Group, said: “The Choice brand is all about accessible wellness. Consumers no longer need to drive to a store to stand in-line and purchase their medical devices and supplies.

“Now, in the privacy of their home, consumers can review, compare and purchase the products of their choice. No insurance is required. Therefore, customers have the freedom of choice. They will no longer be told by their insurance company what brand they can buy. Choice is freedom.”

Guest went on to describe the products as “best in class and very affordable”. He said the company intends to incorporate voice-driven measurement interpretation as well as individualize wellness recommendations via Amazon’s Echo home speaker devices.

“This is all possible with Alexa, and will provide patients with a wellness experience not available until now,” he said.

Amazon is expanding its health-related products to capture more of the market. In June this year, the online retailer announced it is buying PillPack for $1 billion.

The move is expected to disrupt the pharmacy market by delivering pre-sorted medicines and refills to customers’ doors.

PillPack describes itself as “a full-service pharmacy that delivers a better, simpler experience for people managing multiple medications”. The firm liaises with doctors and also provides customer support.

SOURCE: www.pharmaphorum.com/news

Novo Nordisk to launch connected insulin pens in early 2019

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Danish healthcare firm Novo Nordisk has unveiled plans to introduce new durable, connected insulin pens in early 2019.

The new NovoPen 6 and NovoPen Echo Plus connected insulin pens will replace the NovoPen 5 and NovoPen Echo insulin pens.

Novo Nordisk will commence the launch of new connected insulin pens in the first quarter of 2019. They are expected to be available in more than 50 countries.

The company expects to deliver connectivity for its disposable, pre-filled injection pens later in 2019.

Novo Nordisk commercial strategy and corporate affairs executive vice president said: “Our non-exclusive partnership strategy allows us to integrate with the various digital platforms that people are already using to help manage their diabetes.

“We firmly believe that this will help more people realise the full benefit of our innovative medicines and begin to ease the mental burden of diabetes treatment for those individuals.”

In parallel, the company has also entered into new partnership agreements with major diabetes technology firms such as Dexcom, Glooko and Roche to enable future integration of its connected pens with various digital health solutions.

As part of the deal with Roche, the partnership will incorporate insulin dosage information from Novo Nordisk’s connected pen technology into Roche’s open ecosystem, enabling to communicate with its digital diabetes management solutions such as mySugr.

The firm will also incorporate data from connected pen devices with its partners’ diabetes management solutions such as continuous glucose monitoring (CGM) systems and blood glucose meters (BGM).

Novo Nordisk will incorporate insulin dosing data with Dexcom CGM data in the coming years.

Roche diabetes care global head Marcel Gmuender said: “We believe in the tremendous benefits integrated digital diabetes management solutions can bring to people with diabetes, caregivers and healthcare systems as part of an open ecosystem and are excited to partner with Novo Nordisk to further drive innovation in this area.”

With marketing activities in more than 170 countries, Novo Nordisk is engaged in providing treatment solutions for obesity, haemophilia, growth disorders and other serious chronic diseases.

SOURCE: www.compelo.com/medical-devices/news

Roche buys Tusk, plus cancer immunotherapy drug, for £62m

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Roche has bought immuno-oncology biotech firm Tusk Therapeutics for an upfront payment of £62 million.

Tusk’s shareholders will receive the upfront cash payment, plus additional contingent payments of up to £521 million, if and when certain milestones are achieved.

Tusk, which is based in Stevenage, has developed a first-in-class antibody, CD25, for the depletion of regulatory T-cells (TRegs), which suppress the body’s immune reaction to cancer cells.

This novel antibody enables the body’s other immune cells to fight tumours while leaving healthy tissue unharmed. Clinical trials are expected to start next year.

Luc Dochez, CEO of Tusk Therapeutics, said: “We are delighted that Roche will further develop this novel antibody and drive the development ahead.

“The remaining portfolio of our immune-oncology targets will be further developed by Black Belt Therapeutics, a newly formed company spun out of Tusk Therapeutics.”

Droia Oncology Ventures, Tusk’s majority shareholder, founded the company in 2014. Droia is a specialist investor, which focuses on fighting cancer.

It invests in promising new cancer therapies and accelerates their progress by actively supporting young drug development companies to achieve clinical proof of concept with their lead programmes. The deal will expand Roche’s oncology pipeline.

Also, Roche today announced a new collaboration with Novo Nordisk, which specialises in the treatment and management of diabetes and obesity.

The plan is to integrate insulin dosage information from Novo Nordisk’s connected pen technology into Roche’s open ecosystem, whereby it will communicate with its digital diabetes management solutions including mySugr, which allows people to monitor their glucose levels.

Marcel Gmuender, global head of Roche Diabetes Care, said: “The integration of insulin pen data in our digital health solutions such as mySugr will make it much easier for people with diabetes and their caregivers to track the effect of insulin on blood glucose levels.

“This enables more efficient and targeted decision support, as they can act on near real-time insights to optimise the personalised diabetes management, thereby reducing the risk of costly secondary complications and contributing to improved therapy outcomes and better quality of life.”

Anders Toft, corporate vice president of commercial innovation at Novo Nordisk, echoed this, adding: “Digital health solutions like mySugr are already helping thousands of patients. By integrating Novo Nordisk connected technology with mySugr, we can further ease the day-to-day burden of disease management and provide data-based insights to improve the dialogue between patients and caregivers.”

SOURCE: www.pharmaphorum.com/news

Buy-out sets sights on glucose responsive insulin

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Diabetes specialists Novo Nordisk have acquired Ziylo, a University of Bristol spin-out company.

Based at Unit DX science incubator in Bristol, Ziylo has been pioneering the use of its platform technology – synthetic glucose binding molecules – for therapeutic and diagnostic applications.

The acquisition gives Novo Nordisk full rights to Ziylo’s glucose binding molecule platform to develop glucose responsive insulins. The development of glucose responsive insulins is a key strategic area for Novo Nordisk in its effort to develop this next generation of insulin which would lead to a safer and more effective insulin therapy.

“Novo Nordisk is the ideal company to maximise the potential of the Ziylo glucose binding molecules in glucose responsive insulins and diabetes applications, and it brings hope of a truly groundbreaking treatment to diabetes patients,” said Dr Harry Destecroix, chief executive officer and co-founder of Ziylo. “Novo Nordisk is the leader in the diabetes field, with deep clinical development and regulatory expertise and an established commercial infrastructure to deliver important new therapies to patients.”

Ziylo’s glucose binding molecules are synthetic molecules that were designed by Professor Anthony Davis at the University of Bristol. These stable, synthetic molecules exhibit an unprecedented selectivity to glucose in complex environments such as blood. The combination of this technology with state-of-the-art insulin engineering pioneered by Novo Nordisk aims to develop the world’s first glucose responsive insulin and transform the treatment of diabetes.

Novo Nordisk acquires all shares in Ziylo for an upfront payment and earn-outs with contingent milestone payments. Total payments under the agreement could ultimately exceed 800 million dollars upon the achievement of certain development, regulatory and sales milestones by Novo Nordisk.

SOURCE: www.labnews.co.uk/news

Can pharma halt the world’s obesity crisis?

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Major research published in the Lancet this week comes as no surprise, but the findings are still sobering: across the world there are too many people who are not doing enough exercise, putting themselves at risk of diseases such as obesity and type 2 diabetes.

The research published in Lancet Global Health showed that more than a quarter (1.4 billion) adults are at risk from not doing enough physical activity – these diseases are hugely costly to society and to individuals affected.

The levels of insufficient physical activity varied widely across income groups – 16% in low-income countries, compared with 37% in high-income countries.

And in 55 (33%) of 168 countries, more than a third of the population was insufficiently active according to the figures collated in 2016.

In four countries more than half of adults were insufficiently active – Kuwait (67%), American Samoa (53%), Saudi Arabia (53%) and Iraq (52%).

But the regions with the highest increase in insufficient activity over time were high-income Western countries (from 31% in 2001 to 37% in 2016), and Latin America and the Caribbean (33% to 39%).

Countries from these regions driving this trend include Germany, New Zealand, the USA, Argentina, and Brazil.

Authors also identified several socioeconomic forces at work behind the problem – including urbanisation, sedentary occupations, and motorised transport in the richer countries where lack of exercise is most prevalent.

This research will be of interest to the pharma companies that are attempting to tackle diabetes and obesity related diseases, not just with medications but by working with governments to try and influence policy to reduce incidence of the disease.

Leaders in the field such as Novo Nordisk and AstraZeneca are actively campaigning to try and encourage governments to think about how they can encourage people to become more active, and reducing the levels of obesity in society.

With networks of experts in diabetes in countries across the world big pharma companies have realised that there is a huge opportunity to reach out to health systems using corporate social responsibility programmes that aim to tackle the issues outlined in the Lancet research.

For instance Novo has created an initiative entitled “Cities Changing Diabetes” that specifically aims to tackle the problem of “urban diabetes”.

The project involves collecting qualitative and quantitative evidence that could lead to better understanding of the problem and the contributing factors.

It has built up a network of partners across the world, including city leads, city administrations, academia, diabetes associations, health insurances, community centres and business corporations.

So far it has built relations with 16 cities across the world, representing 100 million citizens, including Beirut, Copenhagen, Leicester and Shanghai.

The project is driven by the recognition that the problem with diabetes is only going to get worse unless immediate action is taken.

According to modelling from Novo Nordisk, in order to hold the rise in prevalence at 10%, the world must set itself a target of reducing obesity by 25% by 2045.

Novo organised a Cities Changing Diabetes Summit last year, where it made the call for joint working across sectors and disciplines in order to unite them behind the cause.

Novo has launched an Urban Diabetes Toolbox that gives policy makers tools on how to tackle the problem, including diabetes vulnerability assessment tools, and tips about how to promote healthy living.

AstraZeneca has also been active in this regard, taking part in the multi-year Action in Diabetes initiative and participating in the Global Diabetes Policy Forum in Rome last October.

Now in its third year, the event brought together more than 100 leading global experts in type 2 diabetes care to discuss best practice in policy-making.

Inspired and funded by AstraZeneca, the initiative operates in partnership with the Internatioinal Diabetes Federation, the World Heart Federation, and Primary Care Diabetes Europe, among other organisations.

AstraZeneca’s work aims to demonstrate the interconnectivity between metabolic, cardiovascular, and renal diseases and foster policies that deal with these diseases in an holistic manner.

Eli Lilly is also known for its work in diabetes, and has launched its non-communicable disease partnership with a similar aim.

It has three aims  – piloting new approaches to strengthen diabetes care, advocating to governments for better disease management, and increasing appropriate use of and compliance with medicines to improve outcomes.

The scale of the problem is daunting, but pharma’s focus on raising awareness about the issue, and bringing different stakeholders together towards the common goal of reducing obesity is an example of how industry can help to tackle one of the major social problems of our times.

SOURCE: www.pharmaphorum.com/views-and-analysis

AI Can Deliver Specialty-Level Diagnosis In Primary Care Setting

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A system designed by a University of Iowa ophthalmologist that uses artificial intelligence (AI) to detect diabetic retinopathy without a person interpreting the results earned Food and Drug Administration (FDA) authorization in April, following a clinical trial in primary care offices.

Results of that study were published Aug. 28 online in Nature Digital Medicine, offering the first look at data that led to FDA clearance for IDx-DR, the first medical device that uses AI for the autonomous detection of diabetic retinopathy.

The clinical trial, which also was the first study to prospectively assess the safety of an autonomous AI system in patient care, compared the performance of IDx-DR to the gold standard diagnostic for diabetic retinopathy, which is the leading cause of vision loss in adults and one of the most severe complications for the 30.3 million Americans living with diabetes.

IDx-DR exceeded all pre-specified superiority endpoints in sensitivity, the ability to correctly identify a patient with disease; specificity, the ability to correctly classify a person as disease-free; and imageability, or the capability to produce quality images of the retina and determine the severity of the disease.

“The AI system’s primary role is to identify those people with diabetes who are likely to have diabetic retinopathy that requires further evaluation by an eye-care provider. The study results demonstrate the safety of autonomous AI systems to bring specialty-level diagnostics to a primary care setting, with the potential to increase access and lower cost,” says Michael Abràmoff, MD, PhD, the Robert C. Watzke Professor of Ophthalmology and Visual Sciences with UI Health Care and principal investigator on the study. He is founder and president of IDx, the company that created the IDx-DR system and funded the study.

Early detection may prevent vision loss

More than 24,000 people in the U.S. lose their sight to diabetic retinopathy each year. Early detection and treatment can reduce the risk of blindness by 95 percent, but less than 50 percent of patients with diabetes schedule regular exams with an eye-care specialist.

In the study, 900 adult patients with diabetes–but no history of diabetic retinopathy–were examined at 10 primary care sites across the U.S. Retinal images of the patients were obtained using a robotic camera, with an AI assisting the operator in getting good quality images. Once the four images were complete, the diagnostic AI then made a clinical diagnosis in 20 seconds. The diagnostic AI detects disease just as expert clinicians do, by having detectors for the lesions characteristic for diabetic retinopathy, including microaneurysms, hemorrhages, and lipoprotein exudates.

Camera operators in the study were existing staff of the primary care clinics, but not physicians or trained photographers.

“This was much more than just a study testing an algorithm on an image. We wanted to test it in the places where it will be used, by the people who will use it, and we compared it to the highest standard in the world,” says Abràmoff, who also holds faculty appointments in the UI College of Engineering.

AI measured against gold standard

Study participants also had retinal images taken at each of the primary care clinics using specialized widefield and 3D imaging equipment without AI operated by experienced retinal photographers certified by the Wisconsin Fundus Photograph Reading Center (FPRC)–the gold standard in grading the severity of diabetic retinopathy.

Complete diagnostic data accomplished by both the AI system and FPRC readers was available for 819 of the original 900 study participants. FPRC readers identified 198 participants with more than mild diabetic retinopathy who should be further examined by a specialist; the AI was able to correctly identify 173 of the 198 participants with disease, resulting in a sensitivity of 87 percent. Among the 621 disease-free participants identified by FPRC readers, AI identified 556 participants, for a specificity of 90 percent. The AI had a 96 percent imageability rate: of the 852 participants who had an FPRC diagnosis, 819 had an AI system diagnostic output.

In June, following FDA clearance, providers at the Diabetes and Endocrinology Center at UI Health Care-Iowa River Landing in Coralville, Iowa, were the first in the nation to begin using IDx-DR to screen patients.

“We are hoping to do this also for early detection of diseases like glaucoma and macular degeneration. We are working on those algorithms already. The goal is to get these specialty diagnostics into primary care and retail, which is where the patients are,” Abràmoff says.

IDx is working with the American Medical Association to ensure that there is clear coding guidance for billing of IDx-DR. Providers, physicians, and suppliers should contact their third-party payers for specific and current information on their coding, coverage, and payment policies. IDx is a licensed distributor of the robotic camera used in the study.

SOURCE: www.scienceblog.com/503020

Low dose Aspirin daily – benefits and risks measured in two studies

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Low dose Aspirin has been advocated to reduce the risk of a second heart attack or a stroke or other heart problems in persons who have had one episode.

A major new study published in the Lancet, has found that taking Aspirin to prevent the first heart attack fails to work. In fact the risks of taking low dose Aspirin to prevent the first heart attack outweigh the benefits.

There have been numerous studies on the prophylactic and protective effect of this low cost medication. While certain studies have shown that it can prevent first strokes or heart attacks in persons who are at a moderate risk of heart attacks and strokes, some studies have not shown significant benefit.

Aspirin has also been tested in people with cardiac disease risk factors such as diabetes, high blood pressure, smoking, high cholesterol etc. In diabetes for example Aspirin intake on a regular basis may offer some protection against heart attacks or strokes but the risk of serious bleeding as a side effect of the drug remains high. Aspirin was also purported to have anti-cancer or cancer preventing properties. This has also been negated in studies. In the studies the researchers have used 100 milligrams per day.

Study leader Dr. Jane Armitage of the University of Oxford in England said, “There’s been a lot of uncertainty among doctors around the world about prescribing aspirin. If you’re healthy, it’s probably not worth taking it.” The study was presented this Sunday (26th August 2018) at the European Society of Cardiology meeting in Munich.

In this latest study, the team of researchers from Boston used aspirin or placebo pills on 12,546 participants. These participants had a moderate risk of suffering a heart attack or stroke and other health problems. The participants were followed up for five years and it was seen that 4 percent persons in each group had a heart problem. These participants took medications for lowering blood pressure and cholesterol explained Dr. J. Michael Gaziano of Brigham and Women’s Hospital. Side effects such as internal bleeding or stomach bleeding, was mild but seen twice as much with Aspirin than the placebo pills. Aspirin users also complained more of reflux, abdominal pain, indigestion etc. This new study was sponsored by Bayer.

Low dose aspirin/fish oil supplements in diabetics

In yet another study, researchers from Oxford, randomly assigned 15,480 adults with Type 1 or 2 diabetes with aspirin or 1 gram of fish oil, both the aspirin and fish oil or placebo pills. The pills were administered each day.

The participants were followed for seven and a half years. Heart problems were lower among aspirin users. The risk of bleeding however was raised with aspirin. Fish oil supplements did not help though said study leader Dr. Louise Bowman of the University of Oxford. This study was published by the New England Journal of Medicine.

The British Heart Foundation sponsored the study. Bayer and Mylan provided aspirin and the fish oil supplements, respectively.

SOURCE: www.news-medical.net/news

Ionis/Akcea’s ultra-rare disease drug rejected by FDA

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The FDA has opted to refuse approval to Akcea and Ionis’ Waylivra (volanesorsen) for the treatment of the ultra-rare hereditary condition familial chylomicronemia syndrome (FCS), despite the submission of Phase 3 data from the largest-ever study of the disease.

The US regulator alerted the manufacturers via a complete response letter (CRL), originating from its Division of Metabolism and Endocrinology Products, but the reason for the rejection was not given. Submitted data had shown that Waylivra reduced triglycerides by 94% in patients compared to placebo, which raised levels by 18%

FCS is characterised by extremely elevated triglyceride levels in the blood – levels which can’t be adequately metabolised due to a deficiency off lipoprotein lipase; it severely impacts daily life and can cause a range of damaging conditions including unpredictable and potentially fatal acute pancreatitis, chronic complications due to permanent organ damage.

“We are extremely disappointed with the FDA’s decision. FCS is an ultra-rare and debilitating disease. Our disappointment extends to the patient and physician community who currently do not have a treatment available to them,” commented Paula Soteropoulos, Chief Executive Officer of Akcea Therapeutics. “We continue to feel strongly that Waylivra demonstrates a favourable benefit/risk profile in people with FCS as was reflected in the positive outcome from our Advisory Committee hearing in May. We will continue to work with the FDA to confirm the path forward.”

Dr Brett P Monia, Chief Operating Officer of Ionis Pharmaceuticals, added: “We are fully supportive of WAYLIVRA and the many patients, physicians and researchers who are working to provide the first therapeutic option for FCS, a truly life-altering disease that deserves a treatment.”

SOURCE: www.pharmafile.com/news/518434

Bristol diabetes spin-out company acquired by Novo Nordisk

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The global healthcare company has acquired all of the shares of the Bristol supramolecular chemistry company, of which total payments under the agreement could ultimately exceed $800 million.

Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at the Unit DX science incubator in Bristol, UK.

Ziylo has been pioneering the use of its platform technology – synthetic glucose binding molecules – for therapeutic and diagnostic applications.

The acquisition gives Novo Nordisk full rights to Ziylo’s glucose binding molecule platform to develop glucose responsive insulins.

The development of glucose responsive insulins is a key strategic area for Novo Nordisk in its effort to develop this next generation of insulin, which would lead to a safer and more effective insulin therapy.

A glucose responsive insulin would help eliminate the risk of hypoglycaemia, which is the main risk associated with insulin therapy and one of the main barriers for achieving optimal glucose control. Thus, a glucose responsive insulin could also lead to better metabolic control and overall reduce the burden of diabetes for people living with the disease.

Prior to closing of the acquisition, certain research activities have been spun out of Ziylo to a new company, Carbometrics. Carbometrics has entered into a research collaboration with Novo Nordisk to assist with ongoing optimisation of glucose binding molecules for use in glucose responsive insulins.

Carbometrics has licenced rights to develop non-therapeutic applications of glucose binding molecules, with a focus on developing continuous glucose monitoring applications.

Ziylo’s glucose binding molecules are synthetic molecules that were designed by Professor Anthony Davis at the University of Bristol. These stable, synthetic molecules exhibit an unprecedented selectivity to glucose in complex environments such as blood.

The combination of this technology with engineered insulin pioneered by Novo Nordisk aspires to realise the world’s first glucose responsive insulin and transform the treatment of diabetes.

“We believe the glucose binding molecules discovered by the Ziylo team together with Novo Nordisk world-class insulin capabilities have the potential to lead to the development of glucose responsive insulins, which we hope can remove the risk of hypoglycaemia and ensure optimal glucose control for people with diabetes,” said Marcus Schindler, senior VP, Global Drug Discovery, Novo Nordisk.

“Novo Nordisk is the ideal company to maximise the potential of the Ziylo glucose binding molecules in glucose responsive insulins and diabetes applications, and it brings hope of a truly groundbreaking treatment to diabetes patients,” said Dr Harry Destecroix, CEO and cofounder of Ziylo.

Novo Nordisk has acquired all shares in Ziylo for an upfront payment and earn-outs with contingent milestone payments. Total payments under the agreement could ultimately exceed $800 million upon the achievement of certain development, regulatory and sales milestones by Novo Nordisk.

SOURCE: www.manufacturingchemist.com/news

Denosumab reduces glucocorticoid-induced bone loss

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The drug denosumab was superior to a commonly used drug in a 12-month study enrolling 795 patients.

About one in every 100 people in the world takes glucocorticoids long term to treat immune-mediated diseases. However, glucocorticoids, such as prednisone, have a side effect — they induce the bone loss called osteoporosis, causing an estimated yearly bone fracture rate of 5 percent.

An alternative treatment option now appears promising. The study was headed by Dr Kenneth Saag,the Jane Knight Lowe Professor of Medicine at the University of Alabama at Birmingham.

Dr Saag and colleagues compared the monoclonal antibody denosumab against a standard treatment for glucocorticoid-induced secondary osteoporosis, the bisphosphonate risedronate. In the 12-month results of their 24-month study, they have found that denosumab was superior to risedronate, as measured by increased bone density in the lower spine.

“To our knowledge, ours is the first large, randomised controlled trial of denosumab in patients with glucocorticoid-induced osteoporosis who were either prevalent glucocorticoid users or newly initiating glucocorticoid therapy,” they wrote. “Denosumab could be a useful addition to the treatment armamentarium for glucocorticoid-induced osteoporosis.”

The double-blind study enrolled 795 patients at 79 health care centres in Europe, Latin America, Asia and North America. Of these, 505 were glucocorticoid-continuing patients who had received glucocorticoids for at least three months, and 290 were glucocorticoid-initiating patients who had received glucocorticoids for less than three months.

Patients were randomly assigned to one of two groups. The denosumab group got a shot of denosumab underneath the skin every six months and took a placebo pill every day. The risedronate group got a placebo shot every six months and took oral risedronate every day.

Besides the superior lumbar spine bone density with denosumab after 12 months, researchers also found that denosumab was superior to risedronate for bone density measured in the total hip and at the neck of the femur, the large bone of the thigh.

The two treatment groups had similar safety profiles.

The researchers note that the study compared denosumab with risedronate, so the relative performance of denosumab compared with osteoporosis treatments besides risedronate has not yet been established.

The study has been published in the journal The Lancet Diabetes & Endocrinology.

SOURCE: www.europeanpharmaceuticalreview.com/news/75363