Pharmacologic Management of Osteoporosis - jognn

JOGNN CNE Continuing Nursing Education (CNE) Credit A total of 1.4 contact hours may be earned as CNE credit for reading “Pharmacologic Management of Osteoporosis” and for completing an online posttest and evaluation. AWHONN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. AWHONN holds a California BRN number, California CNE Provider #CEP580 http://JournalsCNE.awhonn.org

Keywords postmenopausal osteoporosis medications pharmacology Correspondence Holly B. Fontenot, PhD, RN, WHNP-BC Boston College William F. Connell School of Nursing 140 Commonwealth Ave Chestnut Hill, MA 02467. [email protected]

The authors and planners for this activity report no conflict of interest or relevant financial relationships. The article includes no discussion of off-label drug or device use. No commercial support was received for this educational activity.

IN FOCUS

Pharmacologic Management of Osteoporosis Holly B. Fontenot and Allyssa L. Harris

ABSTRACT Osteoporosis is a serious health problem of endemic proportions in the United States. Approximately 50% of women will experience an osteoporosis-related fracture during their lifetimes. With the increase in the population of women age 65 and older, nurses need to be familiar with osteoporosis risks, prevention strategies, and screening guidelines to promote well-woman care. We provide an overview of the medications approved by the Food and Drug Administration (FDA) to treat and prevent osteoporosis.

JOGNN, 43, 236-245; 2014. DOI: 10.1111/1552-6909.12285 Accepted July 2013

n 2011, the first members of the Baby Boomer generation in the United States reached age 65, and with each subsequent year 8,000 more individuals will also reach this milestone. In 2010 there were 40.4 million U.S. adults age 65 and older (13.1% of the population); 23 million were women (U.S. Department of Health and Human Services [USDHHS], 2011). The population of the United States is aging, and nurses need to be aware of common diseases associated with this process. Osteoporosis, which primarily affects older women, can be identified and successfully managed with lifestyle and pharmacologic interventions.

I

Osteoporosis is a major health problem. Worldwide, osteoporosis is expected to affect approximately 200 million persons, and approximately one in three women older than age 50 will experience a fracture due to this disease (International Osteoporosis Foundation [IOF], n.d.). Approximately 10 million Americans older than age 50 are diagnosed with osteoporosis, and 34 million with osteopenia (USDHHS, 2004). In the United States it is estimated that one in two White women will experience a fracture of the wrist, hip, or spine compared to one in eight women who will develop breast cancer (Cummings & Melton, 2002; National Osteoporosis Foundation [NOF], 2013a; WHO, 2004). Medical care of individuals with osteoporosis is estimated to cost roughly $14 to $20 billion annually (Becker, Kilgore, & Morrisey, 2010).

Allyssa L. Harris, PhD, RN, WHNP-BC, is an assistant professor at Boston College in Chestnut Hill, MA and a women’s health nurse practitioner at Health Quarters in Beverly, MA.

According to the World Health Organization (WHO, 2004), osteoporosis is defined as a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue that increase the risk for fracture. The WHO (2004) defines osteoporosis as a bone mineral density of –2.5 standard deviations (SD) or more below the average value of young healthy women. Osteoporosis can be further classified into two groups. Primary osteoporosis is related to the normal process of aging and the bone metabolism cycle; secondary osteoporosis occurs when bone metabolism is affected by outside processes, such as medications or a chronic underlying disease. Osteopenia is a related disorder. It is defined as low bone mineral density (density between normal levels and levels for osteoporosis) (Tufts, 2011).

236

C 2014 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses

Holly B. Fontenot, PhD, RN, WHNP-BC, is an assistant professor at Boston College in Chestnut Hill, MA and a women’s health nurse practitioner at the Sidney Borum Jr. Health Center, Boston, MA.

In this article, we provide nurses with a basic understanding of osteoporosis and review the medications approved by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of osteoporosis in postmenopausal women.

Overview of Bone Physiology Bone formation and growth begins during fetal development and continues through adulthood. By age 30 peak bone mass will be achieved. After this point bone growth and development is the result of an ongoing cyclic process of bone formation and reabsorption called remodeling. The cells

http://jognn.awhonn.org

IN FOCUS

Fontenot, H. B. and Harris, A. L.

CNE http://JournalsCNE.awhonn.org

responsible for the remodeling process are osteoblasts and osteoclasts. Derived from hematopoietic and stromal stem cells, osteoclasts are responsible for the reabsorption of bone, whereas osteoblasts are responsible for bone synthesis and mineralization (Raisz, 1999). Together both cells also assist with maintenance of the body’s supply of calcium, magnesium, and phosphorus, which are needed to form healthy bones. Bones are also made of two layers: trabecular and cortical layers. Trabecular bone, found in the inner core, is extremely porous and has a greater surface area. It is highly vascular and is responsible for the production of red blood cells. Trabecular bone is primarily found in the long bones of the skeleton. Cortical bone forms the outer layer of the bone and is less porous. This layer is stiffer, denser, and stronger than trabecular bone (Riggs, 2000).

Table 1: Risk Factors for Osteoporosis Non-modifiable risk factors

Modifiable risk factors

Age

Alcohol/smoking

Female gender

Frequent falls

Family history

Low BMI

Previous fracture

Poor nutrition

Genetic or medical

Excessive salt or vitamin A

disorders Race/Ethnicity

intake Calcium & vitamin D deficiency

Menopause

Eating disorders

Long term glucocorticoid

Estrogen deficiency

therapy Rheumatoid arthritis

Sedentary lifestyle

Note. This list is representative, not comprehensive.

The normal aging process and estrogen loss related to menopause increase a woman’s risk for osteoporosis. Estrogen plays a significant role in the regulation of osteoblast and osteoclast production. However, when estrogen deficiency occurs this regulatory process is disrupted, and the result is a decrease in the production of osteoblast and an increase in osteoclast production. The effect is an increase in bone reabsorption. The loss of estrogen may accelerate bone loss for approximately 5 to 8 years (Norman, 2013). Not only does estrogen loss contribute to the risk of osteoporosis for postmenopausal women, estrogen deficiency early in life can be even more harmful. Amenorrhea due to estrogen deficiency in teens and young adults can have a longterm effect on bone mineral density. Conditions such as female athlete triad, polycystic ovary syndrome, anorexia, and bulimia can all increase a young woman’s risks for osteopenia and osteoporosis (Gordon, 2010). Significant estrogen deficiency during adolescent development, when bone growth and development accelerates, can have long-term health consequences.

Risk Factors for Osteoporosis Other than estrogen loss, multiple nonmodifiable and modifiable factors can place women at risk for osteoporosis. Nonmodifiable risks may include age, gender, race/ethnicity, family history of osteoporosis, and previous fracture. For example, advanced age, being a female, White, Asian, or Hispanic may increase risks (North American Menopause Society [NAMS], 2010). However,

JOGNN 2014; Vol. 43, Issue 2

Women have a greater risk of osteoporosis fractures than breast cancer.

risks are also dependent on other more modifiable factors such as inadequate calcium intake, alcohol use/abuse, and smoking (Rizer, 2006) (see Table 1). Body mass index (BMI) related to being thin or underweight (BMI ≤ 21 kg/m2) has been also associated with an increased risk for fracture, especially with progressing age, whereas a greater BMI can be protective (NAMS, 2010). In addition medical conditions and medications may increase a woman’s risk for osteoporosis. The medications associated with bone loss may include aluminum, anticoagulants, anticonvulsants, aromatase inhibitors, barbiturates, chemotherapeutic drugs, cyclosporine A and Tacrolimus, Depo-medroxyprogesterone, glucocorticoids, gonadotropin releasing hormone agonists, lithium, methotrexate, proton pump inhibitors, premenopausal use of Tamoxifen, and thiazolidinediones (USDHHS, 2004; NOF, 2013a). Diseases of the hypogonadal, endocrine, gastrointestinal, hematologic, autoimmune, rheumatologic, and central nervous systems may all play a role in osteoporosis risk. Examples of specific medical conditions that are associated with bone loss or have detrimental effects to the bone may include excess urinary calcium excretion, vitamin D deficiency, multiple myeloma, hyperparathyroidism and Cushing’s syndrome, disorders of collagen structures, and renal failure (NAMS,

237

IN FOCUS

Pharmacologic Management of Osteoporosis


Types of prescription are based on severity of disease, age, gender, patient tolerance, preference, and cost.

2010). Finally, genetic factors may contribute to osteoporosis and fracture risks, including cystic fibrosis, Ehlers-Danlos syndrome, osteogenesis imperfecta, Riley-Day syndrome, and Marfans syndrome (NOF, 2013a). The result of weakening bone is an increased risk for fracture. Most commonly, fractures related to osteoporosis occur in hip, spine, and wrist (Dempster, 2011). Osteoporosis is associated with approximately two million fractures annually (NOF, 2013a). Because fractures are often the result of osteoporosis, it is important to assess for factors that place patients at risk for falls. Nurses should assess patients for decreased leg or arm muscle strength, diminished vision, environmental hazards, frailty, history of falls, impaired cognition, impaired gait or balance, impaired range of motion, age, low physical function, postural hypotension, and use of any psychotropic medications (Lash, Nicholson, Velez, Harrison, & McCort, 2009).

Universal Recommendations Calcium and vitamin D are essential for bone health. Both play a significant role in the development and growth of bones especially during childhood and adolescence. Ninety percent of the body’s calcium is absorbed through dietary intake and calcium supplements. However, many individuals do not consume a calcium-rich diet. Additionally many individuals are lactose intolerant and therefore do not consume dairy products, a main source of calcium (USDHHS, 2004). Examples of calcium rich foods include dairy products, dark leafy green vegetables, fortified cereals, juice, bread and grains, sardines, and soybeans. Vitamin D is necessary for the absorption and utilization of calcium by the body. The main source of vitamin D is exposure to sunlight. However the amount of sunlight exposure that an individual is able to receive varies. Factors contributing to lower levels of vitamin D include geographical location (individuals in the northern hemisphere may have less sunlight exposure due to extended winter months), skin pigment (individuals with darker pigment process vitamin D slower), amount of skin exposed to sunlight daily (wearing more clothes), and sunscreen use (Lash et al., 2009; USDHHS, 2004).

238

JOGNN, 43, 236-245; 2014. DOI: 10.1111/1552-6909.12285

Evidence has shown that daily supplements of calcium and vitamin D can reduce the risks of fractures (NOF, 2013a). Therefore it is recommended that all women consume a healthy diet rich in calcium and vitamin D fortified foods or take supplements. The recommended dose of daily calcium supplement is 1,200 mg for women age 51 and older (Institute of Medicine, 2010; NOF, 2013a). The normal level for vitamin D in a blood test is 30ng/ml. Individuals below this level should be encouraged to take supplements, and 800 to 1,000 international units are recommended daily (NOF, 2013a). Individuals may increase their sun exposure to the hands, arms, and face for 10 to 30 minutes per day for 2 to 3 days per week, which is equal to the dietary reference intake (Lash et al., 2009; Sweet, Sweet, Jeremiah, & Galazka, 2009). An additional recommendation for the prevention of osteoporosis is daily weight bearing and muscle-strengthening exercise to reduce the risk of falls and fracture (Cummings-Vaughn & Gammack, 2011). This type of exercise includes walking, jogging, stair climbing, dancing, and weight/resistance training. To reduce the risk of falls and injury, an individual safety risk assessment and a home survey to assess for environmental fall hazards should be undertaken. It is also necessary to review a patient’s medication regime for drugs that may cause cognitive impairment and increase the risk for falls. Patients who smoke should be counseled to quit because tobacco products are associated with a statistically significant increased risk of hip fractures (NOF, 2013a). Also, evidence suggests that women who smoke have lower estrogen levels and may have an earlier onset of menopause (Foundation for Osteoporosis Research and Education, 2007). All patients should be evaluated for alcohol consumption. Moderate alcohol intake does not have a direct negative effect on bone health; however, consuming three or more servings per day is associated with an increased risk for falls and injury.

Screening and Diagnosis The U.S. Preventive Services Task Force (USPSTF) recommends osteoporosis screening through bone mineral density (BMD) testing for all women regardless of ethnicity, beginning at age 65. Women who are younger than age 65 and have significant risk factors for fractures should also consider BMD testing. Evidence for the optimal interval for repeat screening is lacking, but the USPSTF (2011) suggested that a minimum of


IN FOCUS



2 years is needed to measure changes in bone mineral density. Screening tests (or peripheral tests) for bone density may include peripheral quantitative computed tomography (pQCT), peripheral dual-energy Xray absorptiometry (pDXA), and quantitative ultrasound (QUS). These peripheral screening tests are commonly used in community-based screening programs to measure the bone mineral density of the lower arm, wrist, finger, or heel. They are useful when central dual-energy X-ray absorptiometry DXA is not available. Peripheral screening can only identify those who should follow up for subsequent DXA testing (NOF, 2013b). Bone mineral density testing is conducted using DXA of the hip and spine and is considered the gold standard for diagnosing osteoporosis (Rizer, 2006; USPSTF, 2011). In DXA, X-ray beams with different energy levels are aimed at the bones, then the absorption of the soft tissue is subtracted from the total amount of X-rays absorbed. DXA is used to measure the difference between the Xrays of soft tissue and bone to assess bone mineral density. This test is noninvasive, painless, low levels of radiation are emitted (less than chest Xray), and it can take 15 minutes or less to complete (NOF, 2013b). Central DXA scores are used to make diagnoses related to bone density. The scores are reported as a T-score or Z-score. The T-score is the difference between an individual’s bone mineral density and the mean bone mineral density for the reference population (healthy 30 year old woman); the lower the T-score the lower the bone density. The Zscore compares the individual’s bone density to what is normal for her age and body size. Because osteopenia is common in older women, comparing one person’s score to others of the same age can make Z-scores misleading. Z-scores are useful for evaluating children, teens, and women still having menses (NOF, 2013b). The WHO developed the Fracture Risk Assessment Tool (FRAX) to assess the 10-year probability of a major osteoporotic fracture of the vertebra, hip, forearm, or proximal humerus (McCloskey, 2009). The calculations comprise the following patient risk factors: gender, age, BMI, height, weight, prior fragility fracture, parental history of hip fracture, current smoking status, history of long-term glucocorticoid use, rheumatoid arthritis, secondary osteoporosis, and alcohol use of three or more units daily. Femoral neck (hip)


bone mineral density may also be entered as a Tscore. The information reported is used to assess risk of fractures and to guide treatment decisions. The use of the FRAX tool is tailored to a country’s population, and the country of origin should be entered when calculating the fracture risk. In the United States, FRAX is intended to be used in postmenopausal women and men age 50 and older and has been validated for use in women and men age 40 to 90 (NOF, 2013b). It is not recommended for use in younger adults and children. The use of the FRAX tool in patients who have received pharmacologic treatment for osteoporosis has not been validated, and practitioners should use their clinical judgment when interpreting results in these cases (NOF, 2013b). The FRAX tool is available free of charge at the University of Sheffield and the NOF websites, and the tool is also available as a desktop application or as an app from Apple’s I-tunes store. The diagnosis of osteoporosis and treatment plan is established after evaluating an individual’s medical history, physical examination, bone density test (DXA), FRAX score. Laboratory tests include blood and urine tests for calcium levels, blood vitamin D levels, thyroid and parathryroid tests, and other biochemical markers. Based on the DXA, the diagnosis of osteoporosis is made if the T-score is –2.5 or less. A diagnosis of osteopenia is made if the T-score is between –1 and –2.5, and normal bone density is a T-score of –1 and above (NOF, 2013b). These numbers in addition to the FRAX can assist health care providers in making decisions regarding a patient’s care, including pharmacologic treatment.

Medications to Treat Osteoporosis in Postmenopausal Women Pharmacologic treatment should be considered for female patients who are postmenopausal and present with the following: hip or vertebral fracture; DXA T-score ≤ –2.5 at the femoral neck or spine post evaluation for other secondary causes; or osteopenia of the spine or femoral neck and a 10 year probability of either hip fracture ( ≥ 3%) or a major osteoporosis related fracture ( ≥ 20%) based on the U.S. adapted FRAX score (NOF, 2013a). Many different pharmacologic options are available for the prevention and treatment of osteoporosis. Decisions for the type of medication

239

IN FOCUS



Patients may have difficulty taking their medications for numerous reasons and understanding their perspectives is critical.

for each individual patient are based on severity of disease, age, gender, patient tolerance, preference, and cost. Various formulations may include tablets, liquids, injections, nasal sprays, and patches. Two main categories of osteoporosis medications exist. First, antiresorptive medications slow bone loss. The goal of treatment is to prevent further loss and reduce a patient’s risk of fracture. Second, anabolic medications increase bone formation. The goal of treatment is to build bone and reduce the risk of fracture (NOF, 2013c). See Table 2 for medications approved by the FDA to prevent and treat osteoporosis, including class, drug, brand name, formulation, and frequency of dosing.

Antiresorptive Medications The goal of antiresorptive therapy is to prevent bone loss, essentially to slow the loss that occurs during the bone resorption (bone breakdown) part of the bone remodeling cycle. Examples of antiresorptive medications include bisphosphonates, calcitonin, estrogen, estrogen agonists/antagonists (also called selective estrogen receptor modulators [SERMs]), and RANK ligand (RANKL) inhibitor (NOF, 2013a). Bisphosphonates. Bisphosphonates include the following: alendronate, ibandronate, risedronate, and zoledronic acid. All bisphosphonates are approved for the prevention and treatment of osteoporosis in postmenopausal women, except Atelvia (a risedronate), which is only approved for treatment. Alendronate and risedronate have been shown to reduce bone loss and increase bone density. Alendronate, risedronate, and zoledronic acid all reduce the occurrence of fractures in the hip, spine, and other bones, and ibandronate reduces the occurrence of spine fractures (NOF, 2013b). Bisphosphonates have been described as having shown “robust efficacy in preventing fractures” (Whitaker, Guo, Kehoe, & Benson, 2012, p. 2048).

240

tentially leading to inflammation and ulcers. With intravenous (IV) formulations patients may experience flu-like symptoms for a few days after the first infusion but not after subsequent infusions (NOF, 2013c). The FDA is also examining the rare but serious reports of adverse events that include osteonecrosis of the jaw, atypical femur fractures, and esophageal cancer (Whitaker et al., 2012). In 2010, the FDA updated the warnings and precautions labels for all bisphosphonates to include risk of subtrochanteric and diaphyseal femur fractures. The FDA is currently reviewing conflicting reports related whether or not bisphosphonate use can affect a patient’s chance of developing esophageal cancer (FDA, 2011). Patients are advised to follow directions for medication use carefully and report any difficulty or pain with swallowing, chest pain and heart burn, as well as new onset thigh or groin pain. Due to these concerns, decisions regarding duration of treatment should be guided by the individual patient’s risk factors. For example, if a patient has a low risk for fracture (T score higher than −2.0) consider discontinuation of medication after 3 to 5 years. However, if a patient is at high risk after 3 to 5 years of treatment (older, with a history of fracture and a T score less than–2.5) consider continuing therapy (Black, Bauer, Schwartz, Cummings, & Rosen, 2012; Whitaker et al., 2012). Calcitonin. Calcitonin is a hormone involved in bone metabolism and calcium regulation that is secreted by cells in the thyroid gland in mammals and by the ultimobranchial gland in fish (salmon) and birds. Calcitonin-salmon is synthetic hormone approved by the FDA for the treatment of osteoporosis in women who are 5 years or more postmenopause (NOF, 2013c; Novartis, 2011). The NOF (2013c) described calcitonin as an agent able to slow bone loss and enhance bone density in the spine, decreasing risk of spine fractures. Side effects with nasal formulations may include a rhinitis, epistaxis, other nasal symptoms, headache, and back or joint pain. Side effects from injectable formulations may include facial or hand flushing, rash, nausea, and urinary frequency (NOF; Novartis, 2011; Upsher-Smith, 2013).

Safety and duration of bisphosphonate treatment is currently under debate. Side effects of bisphosphonates may include a) bone, joint or muscle pain; b) hypocalcemia; c) inflammation of the eye; d) nausea; and e) irritation of the esophagus po-

Estrogen Therapy/Hormone Therapy. Estrogen alone and estrogen plus progesterone (hormone therapy) are approved for the prevention of osteoporosis in postmenopausal women. They have been found to reduce bone loss, increase bone

JOGNN, 43, 236-245; 2014. DOI: 10.1111/1552-6909.12285


IN FOCUS



Table 2: Medications Approved by the Food and Drug Administration (FDA) to Treat and Prevent Osteoporosis Category: Antiresorptive Drug (generic) Bisphosphonates Alendronate

Brand name

Formulation

Frequency

Nursing Considerations

Fosamax

Oral tablet

Daily/weekly

Take first thing in AM; empty stomach, swallow whole with 6–8 ounces (oz.) of plain water 30 minutes prior to eating or drinking; remain upright 30 minutes.

Liquid

Weekly Directions remain same with liquid solution, except drink 2 oz. of plain water after drinking the solution

Fosamax Plus D

Oral tablet

Weekly

R Same as for Fosamax

Boniva

Oral tablet

Monthly

Take first thing in AM; empty

tablet Ibandronate

stomach, whole with 6–8 oz. of plain water; 60 minutes prior to eating or drinking; remain upright 60 minutes. Intravenous

4 x per year

injection

Administered by health professional in less than 1 minute; check serum creatinine before

Risedronate

Actonel

Oral tablet

Daily/weekly/2x monthly/monthly

Take first thing in AM; empty stomach; whole with 6–8 oz. plain water; 30 minutes prior to eating or drinking; remain upright 30 minutes

Actonel with

Oral tablet

Weekly

Calcium

Take calcium tablets daily with food, except for the day of the week the risedronate is taken

Atelvia

Oral tablet

Weekly

Take immediately post breakfast with ≥ 4 oz. plain water; remain upright 30 minutes

Zoledronic acid

Reclast

Intravenous injection

1x per year/1x every 2 Administered by health years

professional; infused over at least 15 minutes; test serum calcium and creatinine before


241

IN FOCUS



Table 2: Continued Category: Antiresorptive Drug (generic) Calcitonin

Brand name

Calcitonin-salmon Miacalcin

Formulation

Frequency

Nursing Considerations

Nasal spray

Daily

For nasal formulations, periodic nasal examinations are recommended

Estrogens

Injection

Dosing varies

Fortical

Nasal spray

Daily

Evista

Oral tablet

Daily

Multiple brands and formulations, please refer to National Osteoporosis Foundation for more information

Estrogen ago-

Raloxifene

Box warning: risk of venous thromboembolism and

nist/antagonist

death from stroke RANK ligand

Denosumab

Prolia

Injection

Every 6 months

Subcutaneous injection

(RANKL)

administered by health

inhibitor

care professional. Consider monitoring serum calcium levels. Supplement with calcium and vitamin D daily

Category: Anabolic Parathyroid

Teriparatide

Forteo

Injection

hormone (PTH)

Daily

Teaching necessary for delivery device (Pen). Box warning: potential risk of osteosarcoma

242

density, and reduce the risks for fractures (NOF, 2013c). However, estrogen and hormone therapy are primarily indicated for the relief of menopausal symptoms, specifically vasomotor symptoms and vulvovaginal atrophy. Due to the risks associated with these therapies (breast cancer, stroke, and thromboembolic events) they should not be considered solely for osteoporosis prevention. If utilized, NAMS (2010) recommends the lowest effective treatment dose.

demonstrated to decrease the risk of vertebral fractures. Raloxifene is also approved to decrease risks associated with breast cancer with or without a concurring diagnosis of osteoporosis. Side effects of raloxifene may include vasomotor symptoms, leg cramps, swelling, and increased risk for deep vein thrombosis (NOF, 2013c). Raloxifene does not increase risks for cataracts, gallbladder disease, endometrial hyperplasia, endometrial cancer, or breast pain (NAMS, 2010).

Estrogen Agonists/Antagonists. Raloxifene is approved for the prevention and treatment of osteoporosis in postmenopausal women and has been

RANK Ligand (RANKL) Inhibitor. Denosumab is the only approved RANKL inhibitor for the treatment of postmenopausal osteoporosis in

JOGNN, 43, 236-245; 2014. DOI: 10.1111/1552-6909.12285


IN FOCUS



high- risk women. This medication is a human monoclonal antibody that prevents the interaction of nuclear factor-kB ligand with RANK, thereby inhibiting the development and activity of the osteoclast. Therefore, it is useful in decreasing bone resorption and decreasing bone density. Its action is differs from bisphosphonates, which block osteoclast function and survival but not the formation as well (Cummings et al., 2009). Denosumab has been associated with a significant risk reduction of vertebral, hip, and non-vertebral fractures (Cummings et al., 2009; NOF, 2013c). Side effects of this medication may include hypocalcemia and skin infections/irritations (cellulitis, dermatitis, eczema and rash). Denosumab has also been associated with osteonecrosis of the jaw (in patients treated with this medication for cancer) and atypical femoral fractures (Amgen, 2012; NOF, 2013a). Researchers have reported the benefits of denosumab, including ease of administration, patient preference, and adherence (Josse, Khan, Ngui, & Shapiro, 2013; Miller, 2009).

Anabolic Medications This medication is a type of parathyroid hormone, Teriparatide. Parathyroid hormone (PTH) is secreted by the parathyroid gland when serum calcium levels are low to enhance calcium uptake in the intestine, calcium reabsorption in the kidney, and to stimulate osteoclast and osteocyte mediated calcium release from bone (Baron & Hesse, 2012). Currently, PTH is only available in injectable (subcutaneous) formulation in the United States and is the only osteoanabolic drug approved for the treatment of osteoporosis. The PTH reduces fracture risk of the spine and increases bone formation along the periosteum, which is a primary surface for bone modeling. One noted limitation is related to a plateauing effect where the side effect of bone resorption of PTH slowly catches up with bone formation at approximately 18 to 24 months of drug use. Therefore, researchers are examining potential administration of an antiresorptive drug combined with PTH to create a synergistic effect in patients at high risk for fracture (Baron & Hess, 2012). Side effects of teriparatide include leg cramps, vertigo, pain, nausea, and modest rise in serum and urine calcium. An increased risk of kidney stones has not been documented (Eli Lilly & Co., 2012; NOF, 2013c). High doses of teriparatide for prolonged periods of time have been documented to increase the incidence of osteosarcoma in rats. Therefore, it is not recommended for patients to


use this medication for more than 2 years during their lifetimes (Eli Lilly & Co., 2012; NOF, 2013c).

Medication Follow-Up According to NOF (2013a) patients taking medications to treat osteoporosis should have laboratory and bone density reevaluation after 2 years of therapy or more frequently as clinically determined. More frequent testing and laboratory analysis to monitor treatment is provider and patient dependent. For example, accurate vertical height measurement should be noted each year for a patient, and a significant loss in height may indicate the need for additional imaging. The duration of treatment with the various medications is still being examined, and future research is needed to understand the long-term risks and benefits and the optimum treatment period. Nonbisphosphonate medication effects may wane rapidly when discontinued, whereas, bisphosponates may retain longer term fracture prevention benefits, but efficacy has not been fully evaluated beyond 5 years (NOF, 2013a).

Nursing Implications The latest research is being conducted to examine the effects of patient preference and adherence to osteoporosis pharmacologic therapies as well as prevention measures. Patients may have difficulty taking medications for numerous reasons, and understanding the patient’s perspective is critical. Not only should patients be following their medication regimens, but also they should continue to exercise regularly and ensure they have adequate intake of calcium and vitamin D to maximize the treatment effect. Silverman and Gold (2010) discussed patient risks associated with adherence to dosing intervals and instructions, provider communication and attitudes, the asymptomatic nature of the disease, and psychosocial factors (depression and alcohol use) in relation to patient compliance and persistence with osteoporosis medications. It is evident that improving fracture outcomes related to patient treatment plan adherence will take a multifaceted psychosocial and economical approach that includes examining the nurse’s role. Also, many patients are not aware of their risks for osteoporosis, recommendations for prevention, or the need for screening. In a survey conducted by the International Osteoporosis Foundation (2000), significant disparities between women’s knowledge of osteoporosis severity and their personal risk were identified. Ninety-three percent of

243

IN FOCUS



postmenopausal women acknowledged the severity of the disease, however, only two in 10 women believed that they were at risk for developing osteoporosis. Kasper, Garber, and Walsdorf (2007) examined college women’s knowledge and beliefs about osteoporosis (N = 302). In this sample, 98% had knowledge of osteoporosis, but only 50% were able to identify six of 16 osteoporosis risk factors. Although participants believed that osteoporosis was a serious disease, most believed that is was less serious than heart disease and breast cancer. Also, among ethnic groups African American participants had lower knowledge scores, were less likely to correctly identify risk factors, and were less likely to believe were at risk. It is evident that there is a need for education for nurses in the community setting and for nurse researchers to develop and test osteoporosis prevention interventions.

whom and for how long? New England Journal of Medicine, 366(22), 2051–2053. Cummings, S., & Melton, L. (2002). Epidemiology and outcomes of osteoporotic fractures. Lancet, 359, 1761–1767. Cummings, S., San Martin, J., McClung, M., Siris, E., Eastell, R., Reid, I., . . . Christiansen, C. (2009). Denosumb for prevention of fractures in postmenopausal women with osteoporosis. New England Journal of Medicine, 361, 756–765. doi:10.1056/ nejoma0809493 Cummings-Vaughn, L., & Gammack, J. (2011). Falls, osteoporosis, and hip fractures. Medical Clinics of North America, 95, 495–506. doi:10.1016/j.mcna.2011.03.003 Dempster, D. (2011). Osteoporosis and the burden of osteoporosis related fractures. American Journal of Managed Care, 17, s164– s169. Eli Lilly & Company. (2012). Highlights of prescribing information. Retrieved from http://www.pi.lilly.com/us/forteo-pi.pdf Foundation for Osteoporosis Research and Education. (2007). Evaluation and management of osteoporosis and fracture risk in postmenopausal women: Guidelines for patient evaluation. Retrieved from http://www.fore.org/professionals/np_program.html Gordon, C. (2010). Functional hypothalamic amenorrhea. New England Journal of Medicine, 363, 365–371. Institute of Medicine. (2010). Dietary reference intake for calcium and vitamin D. Retrieved from http://www.iom.edu/Reports/

Conclusions With an increasingly aging population many women will be at greater risk for developing osteoporosis, and associated risks of fracture will continue to rise. Worldwide, approximately 1.6 million fractures occur annually with a projected increase to 4.7 million by 2050 (IOF, n.d.). These statistics are a mandate for nurses to enhance their knowledge about this disease and its management and conduct research to develop effective interventions that focus on prevention. Prevention efforts should target new mothers and women seeking preconception counseling and address bone health, need for exercise, and adequate nutrition, including calcium and vitamin D requirements. This preventative education can be reinforced by nurses in the pediatric and adolescent settings to ensure continued prevention efforts. In addition to prevention efforts, knowledgeable nurses are needed to manage the multi-factorial aspects of osteoporosis care to promote fracture prevention and enhance effective pharmacological management of this disease.

2010/Dietary-Reference-Intakes-for-Calcium-and-Vitamin-D/ Report-Brief.aspx. International Osteoporosis Foundation. (2000). How fragile is her future? Retrieved from http://www.iofbonehealth.org/how-fragileher-future International Osteoporosis Foundation. (n.d.) Facts and statistics. Retrieved

from

http://www.iofbonehealth.org/facts-statistics

#category-23 Josse, R., Khan, A., Ngui, D., & Shapiro, M. (2013). Denosumab, a new pharmacotherapy option for postmenopausal osteoporosis. Current Medical Research & Opinion, 209, 205–216. doi:10.1185/03007995.2013.763779 Kasper, M., Garber, M., & Walsdorf, K. (2007). Young women’s knowledge and beliefs about osteoporosis: Results from a crosssectional survey of college females. American Journal of Health Education, 38, 186–193. Lash, R., Nicholson, J., Velez, L., Harrison, R. V., & McCort, J. (2009). Diagnosis and management of osteoporosis. Primary Care: Clinics in Office Practice, 36, 181–198. doi:10.1016/j.pop.2008.10.009 R McCloskey, E. (2009). FRAX : Identifying people at high risk of

fracture. Retrieved from www.osteoporosis.org.za/downloads/ FRAX-report-09.pdf Miller, P. (2009). Denosumab: anti-RANKL antibody. Current Osteoporosis Reports, 7, 18–22. National Osteoporosis Foundation. (2013a). Clinician’s guide to prevention and treatment of osteoporosis. Washington, DC: Author. National Osteoporosis Foundation. (2013b). Having a bone density test. Retrieved from http://www.nof.org/articles/743

REFERENCES R Amgen. (2012). Prolia Important safety information. Retrieved from

http://www.proliahcp.com/safety-profile/ Baron, R., & Hesse, E. (2012). Update on bone anabolic in osteoporosis

medication. Retrieved from http://www.nof.org/articles/22 North American Menopause Society. (2010). Management of osteoporosis in postmenopausal women: 2010 position statement of

treatment: Rationale, current status, and perspectives. Journal

The North American Menopause Society. Menopause, 17, 23–

of Clinical Endocrinology & Metabolism, 97(2), 311–325.

54.

Becker, D., Kilgore, M., & Morrisey, M. (2010). The societal burden

Norman, J. (2013). The effects of menopause on bone strength,

of osteoporosis. Current Rheumatology Report, 12, 186–191.

calcium and osteoporosis and the influence of estrogen

doi:10.1007/s11926-010-0097-y.

on osteoporosis. Retrieved from http://www.endocrineweb.

Black, D., Bauer, D., Schwartz, A., Cummings, S., & Rosen, C. (2012). Continuing bisphosphonate treatment for osteoporosis–For

244

National Osteoporosis Foundation. (2013c). Types of osteoporosis

JOGNN, 43, 236-245; 2014. DOI: 10.1111/1552-6909.12285

com/conditions/osteoporosis/osteoporosis-osteoporosiswomen


IN FOCUS


CNE http://JournalsCNE.awhonn.org Novartis. (2011). Miacalcin

R

(calcitonin-salmon) Nasal Spray, Rx

only, prescribing information. Retrieved from http://www.pharma.

bisphosphonates, and atypical fractures. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm229009.htm U.S. Food and Drug Administration. (2011). FDA drug safety

us.novartis.com Raisz, L. (1999). Physiology and pathophysiology of bone remodeling.

communication: ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of

Clinical Chemistry, 45, 1353–1358. Riggs, L. (2000). The mechanisms of estrogen regulation of bone resorption. Journal of Clinical Investigation, 106, 1203–1204. Rizer, M. (2006). Osteoporosis. Primary Care: Clinics in Office Practice,

esophageal cancer. Retrieved from http://www.fda.gov/Drugs/ DrugSafety/ucm263320.htm U.S. Preventive Services Task Force. (2011). Screening for osteoporosis: Recommendation statement. Rockville, MD: Author.

33, 943–951. doi:10.1016/j.pop.2006.09.004 Silverman, S., & Gold, D. (2010). Compliance and persistence with osteoporosis medications: a critical review of the literature. Reviews in Endocrine and Metabolic Disorders, 11, 275–280.

Retrieved from http://www.uspreventiveservicestaskforce.org/ uspstf10/osteoporosis/osteors.htm Whitaker, M., Guo, J., Kehoe, T., & Benson, G. (2012). Bisphosphonates for osteoporosis- where do we go from here? New England Jour-

doi:10.1007/s11154-010-9138-0 Sweet, M. G., Sweet, J., Jeremiah, M., & Galazka, S. (2009). Diagnosis and treatment of osteoporosis. American Family Physician, 79,

nal of Medicine, 336(22), 2048–2051 World Health Organization. (2004). WHO Scientific Group on the Assessment of Osteoporosis at Primary Health Care Level. Re-

193–200. Tufts, G. (2011). New treatment approaches for osteopenia. Journal

trieved from www.who.int/chp/topics/Osteoporosis.pdf

of Midwifery & Women’s Health, 56, 61–67. doi:10.1111/j.15422011.2010.00003.x R

Upsher-Smith. (2013). Fortical

calcitonin-salmon (rDNA or-

gin) Nasal Spray, Rx only, package insert. Retrieved from http://www.fortical.com

Continuing Nursing Education To take the test and complete the evaluation, please visit http://JournalsCNE.awhonn.org.

U.S. Department of Health and Human Services. (2004). Bone health and osteoporosis: A report of the surgeon general. Rockville, MD:

Author.

Retrieved

from

http://www.surgeongeneral.

gov/library/reports/bonehealth/ U.S. Department of Health & Human Services, Administration on Aging. (2011). A profile on older Americans: 2011. Retrieved from www.aoa.gov/aoaroot/aging_statistics/Profile/.../2011profile.pdf U.S. Food and Drug Administration. (2010). FDA drug safety communication:

safety

update


for

osteoporosis

drugs,

Certificates of completion will be issued on receipt of the completed evaluation form, application and processing fees. Note: Accredited status does not imply endorsement by AWHONN or the American Nurses Credentialing Center of any commercial products displayed or discussed in conjunction with this activity.

245