KEL531
TIM CALKINS
Forecasting Denosumab
“Our job is quite simple,” explained Jennifer Fry, project manager at Oakdale Strategy
Group, a strategy consulting firm based in Chicago. It was a cold day in early February 2011, and
Fry was meeting with her team. “We’ve been asked to develop a forecast for denosumab for
2015,” she continued. “Our client is one of the world’s largest pharmaceutical firms. The senior executives there are taking a close look at acquiring Amgen and want an outside opinion about denosumab.” Steven Meyers, a partner at the firm, quickly jumped in. “This is an incredibly high-profile assignment because the value of Amgen is closely tied to the revenue forecast for denosumab.
We’ve got an important client and a very
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In young people, bone is created faster than it is broken down, so bone mass increases and bones strengthen. In older people, however, this balance is reversed. Bone strength generally peaks at about the age of 30. As bones weaken with age, people develop osteopenia, a reduction in bone mass. If the process continues, people develop osteoporosis. Osteopenia and osteoporosis can occur at any age, but it is most common among people older than 50. Women are four times more likely than men to develop osteoporosis. As a woman’s levels of the hormone estrogen declines (such as during menopause), her risk of bone loss significantly increases.
With no obvious symptoms, osteopenia and osteoporosis often go undetected until a diagnosis from a healthcare professional. Untreated, a person can continue living with osteoporosis for many years. The risk of a fracture during this time, however, increases significantly. Fractures are a significant issue for older people. One study of postmenopausal women with osteoporosis reported that 10.9 percent had a vertebral fracture and 2.5 percent had a hip fracture during a three-year period.3
The main way to diagnose osteoporosis was with a bone mineral density (BMD) test. The primary BMD test was dual-energy X-ray absorptiometry (DXA). During a measurement process that generally took between ten and twenty minutes, a DXA scanner produced two X-ray beams with different
Osteoporosis is a detrimental bone condition, the tissue in the bones deteriorate and thus the bones become progressively brittle which presents a risk for rupture. Osteoporosis impacts more than 44 million Americans and is linked to a suggested 2 million bone fractures each year. According to the National Osteoporosis Foundation, the amount of fissures due to osteoporosis may escalate above 3 million by the year 2025. Osteoporosis is typically undetected and advances with slight warning signs until a fissure ensues. Effects of osteoporosis encompass height reduction and a curved upper back, anyone can have osteoporosis, however it is prevalent in elderly women and many may break a bone due to this condition. Recovery and prevention are vital in combating osteoporosis, though it may never be eradicated one can take measures to stabilize bone density and gain strength.
As generally stated in the introduction, osteoporosis is a skeletal disorder that involves the strength and integrity of one’s bones. The WHO defines osteoporosis as, “a systemic skeletal disorder characterized by low-bone mass, deterioration of bone tissue, increased bone fragility, and its susceptibly to recurrent fractures.” 2 The most important factor to take into account when addressing osteoporosis is the mass of bone, also referred to as, bone mineral density (BMD). As bone mass begins to decline, typically in the older population, specifically postmenopausal women, individuals are at an increased risk for fractures.3 As a result of this serious condition, many people are affected by morbidity, mortality, and economic difficulty.1
Throughout a lifetime, old bone is removed (resorption) and new bone is added (formation) to the skeleton. During childhood and teenage years, new bone is added faster than old bone is removed. Consequently, bone become larger, heavier, and denser. Bone formation continues at a pace faster than resorption until peak bone mass, which is reached around age 30. After age 30, bone resorption slowly exceeds bone formation. In women, bone loss is most rapid in the first years after menopause but persists throughout the postmenopausal years. Based on year 2000 census data, it is estimated that 55% of people age 50 and older have either osteoporosis or low bone mass. The major risk
Osteopenia means that the bone is thinning which could lead to fractures. Bone thinning leads to osteoporosis. Decreased bone density occurs as people age. BMD determines bone strength and it peaks around 25-30 years of age. After these peak years, bone breabsorption exceeds bone building which causes a decrease in bone density.
Osteoporosis is an age related disorder, more common in females compared to males. Osteoporosis is defined as a “skeletal disorder characterized by compromised bone strength predisposing to increased risk of fractures (Manolagaas, 2014). Osteoporosis is defined as “a disease characterized by low bone mass and deterioration of bone tissue (What is osteoporosis?2014). Osteoporosis is sometimes also referred as “silent thief” as the bone loss occurs very slowly and silently without any symptoms (Osteoporosis facts & statistics.2014). The most common site for fracture due to osteoporosis is hip followed by humerus (Woltman & den Hoed, 2010) . Osteoporosis can occur at any age, although it is a disorder common in females (especially post-menopausal females). Everyone is prone to osteoporosis (Osteoporosis facts & statistics.2014). According to Osteoporosis Canada, 1 in 3 Canadian females and 1 in 5 Canadian males may suffer fractures due to osteoporosis during their lifetime (Osteoporosis facts & statistics.2014). Canadian health care system spends 1.2 billion dollars for the acute hospitalization caused by osteoporosis and in 2010 the health care system spent 3.9 billion dollars for the total treatment of osteoporosis (Osteoporosis facts & statistics.2014). Osteoporosis can be screened and diagnosed by various methods; however the dual energy x ray absorptiometry (DXA) is commonly used. If the T-score values are less than -1 and greater than -2.5SD it is termed as osteopenia,
396). When blood calcium needs to be replenished, the trabecular bone gives up minerals. The loss of trabecular bone is significantly apparent in men and women in their 30s. However, the trabecular bone can start to desintegrate whenever calcium withdrawals exceed deposits. Furthermore, cortical bone also gives up calcium, however this occurs at a slower and steadier pace. The cortical bone begins to give up ususally around someone in their 40s. Therefore, as bone loss continues, bone density begins to decline, which causes osteoporosis to become apparent. For instance, "Bones become so fragil that even the body's own weight can overburden the spine - vertebrae may suddenly disintegrate and crush down, painfully pinching major nerves" (Whitney & Rolfes, 2013, p. 396). Nonmodifiable risk factors for osteoporosis tend to occur in the older age, female gender, smaller frame Caucasian, Asian, or Hispanic/Latino. In addition, it occurs in people with family history of osteoporosis or fractures. However, modifiable risk factors include, sedentary lifestyle, diet inadequare in clacium and vitamin D, diet excessive in protein, sodium, caffeine, cigarrette smoking, alcohole abuse and low
Osteoporosis is developed when the bones lose minerals (such as calcium) too quickly and the body cannot replace them fast enough. This causes bone density to decrease and the bones to become porous, making them more fragile and susceptible to breaking. There are many risk factors for osteoporosis, some of which can be changed, some of which cannot. Those that cannot be changed include gender (women are more likely to develop osteoporosis), age (older people have a higher risk), physical build (smaller people have more of a chance), and family history (those with parents who have/had osteoporosis are more at risk). However, factors that can be changed include the level of sex hormones, diet, inactive lifestyle, excessive use of alcohol, smoking,
There are two types of osteoporosis that have been identified which are primary and secondary. Osteoporotic bones are thin and brittle and are prone to fracture. The bone loss involves both compact and spongy bone. In type I osteoporosis, which occurs typically in postmenopausal women, spongy bone loss predominates, occurring most prominently in the vertebrae and distal radius (Gueldner, Burke, Smiciknas-Wright, 2000). Major complications of type I osteoporosis are crush fractures of the vertebral bodies and the distal end of the radius. Type II, or old-age, osteoporosis is characterized by a proportional loss of compact and spongy bone of the long bones (Gueldner, Burke, Smiciknis-Wright). The most serious fractures of old age are those of
According to the National Osteoporosis Foundation, nearly one quarter of men and an astonishing fifty percent of women will break a bone due to osteoporosis. Women are primarily affected by this due to menopause or
Osteoporosis is a disease of bone that leads to an increased risk of fracture. In osteoporosis the bone mineral density (BMD) is reduced, bone microarchitecture is disrupted, and the amount and variety of non-collagenous proteins in bone is altered. Osteoporosis is defined by the World Health Organization (WHO) in women as a bone mineral density 2.5 standard deviations below peak bone mass (20-year-old healthy female average) as measured by DXA; the term "established osteoporosis" includes the presence of a fragility fracture.[1] Osteoporosis is most common in women after menopause, when it is called postmenopausal osteoporosis, but may also develop in men, and may occur in anyone in the presence of particular hormonal
Osteoporosis is caused by bones losing their density. This is because the process turnover where the bones are renewed and repaired, as you age this process slows down making the bones lose density and leads to the bones becoming weaker and more
As a major public health issue, osteoporosis accounts as a very common disorder. It is characterized by low bone density and deterioration of bone microarchitectural tissue leading to fragility and increased risk of fracture. Along with progressive aging of the world 's population, osteoporosis is expected to be seen with a higher incidence in the elderly. As osteoporosis has a silent course, proper methods of screening, diagnosis, and treatment are of vital importance.
Osteoporosis is a skeletal, chronic disease, which is characterized by diminished bone strength and deterioration of bone tissue, that results in increased fracture risk, especially in the wrist, hip, and spine (CDC,2012;NIH, 2001). In osteoporotic patients, bone mineral density (BMD) is ≥2.5 standard deviation below the mean for healthy young adults at the spine, femoral neck or total hip (Lewiecki et al., 2008).The disease is a common old-age problem and most prevalent among postmenopausal women and the elderly with high prevalence affecting 1 in 3 women and 1 in 5 men by the time they reach
There are several conditions that contribute to osteoporosis other than the aging process that causes elders to lose bone density, to understand the correlation of the condition one should have a basic understanding of what osteoporosis is. As stated, osteoporosis is called a silent disease with an underlying origin that is undetected or misdiagnosed since the symptoms are so nondescript until the damage is done. This condition is characterized by decrease bone mass density (BMD), the principal progression is bone fragility with undetermined body fractures, and bone mineral density decrease with aging; defines osteoporosis which yields brittle bones found in both genders. Although, women experience this process more
It has been shown that NTX and CTX and markers of bone formation remain elevated in women for 40 years after the menopause (106).