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Flashcards in 27 Osteoporosis Lieu Deck (161):
1

When does the primary diagnosis of osteoporosis usually occur?

Fracture of hip, spine, wrist, or humerus that occurred spontaneously or after a fall from no greater than standing hight

2

What is osteoporosis characterized by?

Low bone mass. Deterioration of bone tissue. Disruption of bone architecture. Compromised bone strength. Increase in risk of fracture

3

What are the consequences of osteoporosis?

Fractures: vertebrae (spine), proximal femur (hip), distal forearm (wrist), others. Followed by full recovery or by chronic pain, disability, death

4

What population has the highest incidence of osteoporosis?

Non-Hispanic Caucasian and Asian, aged 50 and older

5

What is Trabecular bone (cancellous bone)?

Forms porous interior structure of bone. Primarily: vertebrae, distal forearm, hip. Fastest rate of turnover (more metabolically active)

6

What is Cortical bone?

Forms hard outer shell of skeleton. Predominates: long bones (proximal femur, distal radius)

7

What type of bone do skeletal bones consist of?

20% trabecular, 80% cortical

8

What is Type 1 Osteoporosis?

Predominant loss of trabecular bone (up to 25%) associated with menopause. Leads to an increase in "crush" type vertebral fractures, distal forearm fractures, ankle fractures

9

What is Type 2 Osteoporosis?

Loss of cortical and trabecular bone associated with aging. Leads to an increase in hip fractures

10

What are the general characteristics of osteoporosis?

Loss of trabecular and cortical bone mass. Reduction in skeleton load carrying capacity --> bone fragility. Significant bone loss evident only after vertebral or hip fracture occurs. Not an "old woman's disease"

11

Why is early diagnosis of osteoporosis important?

Early osteoporosis is asymptomatic. Osteoporosis can develop undetected for decades until fracture occurs

12

What are the odds of osteoporosis related fractures in remaining lifetime after 50 years of age?

Approximately 1 in 2 women and 1 in 4 men

13

What are some characteristics of Hip Fractures?

Women with him fracture: 4-fold greater risk of second one. 2-3 times higher rate in women vs. men. Following hip fracture: 1-year mortality nearly twice as high for men vs. women (within 1 year 24% of patients > 50 years old die)

14

What are the complications of vertebral fractures?

Back pain, height loss, kyphosis (postural changes, limit bending and reaching). Mortality increased

15

What can multiple thoracic fractures cause?

Restrictive lung disease

16

What can lumbar fractures cause?

Constipation. Abdominal pain. Distention. Reduced appetite. Premature satiety

17

When does osteoporosis prevention begin?

In childhood (even before, in utero). Bone mass attained during childhood is perhaps the most important determinant of life-long skeletal health

18

What are the major determinants for the risk of osteoporosis?

Peak bone mass. Bone loss thereafter

19

What is Peak Bone Mass?

Maximum amount of bone tissue an individual attains. Bone mineral density increases with age (20-25 years). Peak bone mass is achieved by the late 20s or early 30s in men and women, after cessation of linear growth. Largely genetically determined (80%)

20

What is Peak Bone Mass influenced by?

Body weight, physical activity, normal pubertal development, mechanical loading, adequate nutrition

21

How does Bone Mass change?

Usually, removal (osteoclasts) and formation (osteoblasts) of bone are in balance and maintain skeletal strength and integrity. After ~age 30, bone resorption begins to outpace bone formation --> bone mass gradually declines

22

What do decreased estrogen levels in women cause?

Increase in bone loss. Begins several years prior to onset of menopause. Women can lose up to 20% of their bone mass in the 5-7 years following menopause. Also, prior to menopause, during ovulatory disturbances

23

What is Bone Mass Density (BMD) like for women?

Decline in BMD: approx 50% during average lifetime. Magnitude of bone loss: greater for some women, less for others

24

What is Bone Mass Density (BMD) like for men?

Bone loss at approx 1/2 rate of women. Decline in BMD: approx 35% during average lifetime

25

What are some risk factors of osteoporosis and fractures?

Female. Older age. FHx. Being small/thin. History of broken bones. Low sex hormones. Smoking. Alcohol (> 3 drinks/day). Diet. Inadequate physical activity. Immobilization. Falls. Certain medications. Certain diseases and conditions

26

What falls under "low sex hormones" for a risk factor for osteoporosis?

Low estrogen in women, including menopause. Missing periods (amenorrhea). Low levels of testosterone and estrogen in men

27

What falls under "diet" for a risk factor for osteoporosis?

Low calcium intake. Vitamin D insufficiency. Excessive intake of protein, sodium, caffeine, Vitamin A

28

What are some example conditions and diseases that cause or contribute to osteoporosis and fractures?

Cystic fibrosis. Anorexia/Bulimia. DM. Celiac disease. Leukemia. RA. Alcoholism. CHD. ESRD

29

What are some modifiable risk factors for osteoporosis?

Cigarette smoking. Excessive alcohol consumption. Excessive caffeine consumption. Prolonged immobilization. Low levels of physical activity. Lack of weight-bearing exercise. Lack of sun exposure. Inadequate calcium intake. Inadequate vitamin D status. Elevated homocysteine level

30

What are the essential nutrients for bone?

CALCIUM. VITAMIN D. MAGNESIUM. PHOSPHORUS. Vitamin B-12. Folic Acid. Vitamin B-6. Vitamin K. Vitamin C. Zinc. Copper. Boron. Manganese. Fluoride. Essential fatty acids

31

Whats a good way to increase BMD?

Increased Magnesium and Potassium. Higher overall fruit and vegetable intake

32

What increases the risk of osteoporosis with higher intakes?

Protein (animal > vegetable). Sodium. Phosphoric acid-containing beverages (soda, carbonated beverages). Sugar. Vitamin A (retinol > 1.5mg/day; 5,000 IU/day)

33

What are some medications that can contribute to osteoporosis?

Anticoagulants. Anticonvulsants (phenytoin, phenobarbital). Aromatase inhibitors. Barbiturates. Cyclosporine, tacrolimus. GnRH/LH-RH agonists. Lithium. SSRIs. PPIs, H2RAs. Glucocorticoids. Thiazolidinediones

34

How is prostate cancer related to osteoporosis?

Prostate cancer and androgen suppression treatment both contribute to increased bone loss. Androgen deprivation therapy (ADT): reduces BMD ~3-7%

35

For BMD, when are Z scores (not T scores) recommended?

For women with known causes of osteoporosis, history of low-trauma fracture. Routine screening of BMD is NOT recommended for pre-menopausal woman

36

What do the different Z-scores tell you?

Z-score above -2.0: within the expected range for age. Z-score -2.0 or lower: below the expected range for age

37

When can a diagnosis of osteoporosis be made for pre-menopasal women?

Low-trauma or atraumatic fractures and/or reduced BMD: Z-score -2.0 or below

38

What are the most common underlying secondary causes of osteoporosis in pre-menopausal woman?

Anorexia nervosa. Other eating disorders. Glucocorticoids

39

What is the management done for pre-menopausal osteoporosis?

Treat underlying disorder. Address lifestyle risk factors

40

What is done for pre-menopausal osteoporosis with just borderline low BMD and no secondary cause?

Pharmacological therapy not justified. Optimize bone health with nonpharmacologic interventions

41

What is the relationship between SERMs and Pre-Menopausal osteoporosis?

SERMs contraindicated in pre-menopausal menstruating women: block estrogen action on bone and can lead to enhanced bone loss

42

Why must bisphosphonates be used with caution for pre-menopausal osteoporosis?

Accumulate in skeleton and unknown effects on human fetus. Use may be justified: rapid bone loss (e.g, transplantation and post-transplantation osteoporosis)

43

What are some risk factors for bone health in children and adolescents?

Premature and low birthweight w/ lower than expected bone mass in first few months of life. Glucocorticoids. Cystic fibrosis, celiac disease, inflammatory bowel disease. Renal disease, liver failure. Cerebral palsy. Anorexia. Pregnant mom with low zinc level. 2+ fractures d/t minimal trauma: DXA recommended

44

What is the best measurement of bone mineral density?

Dual-Energy X-Ray Absorptiometry (DEXA) of hip and spine

45

Who should have BMD testing regardless of risk factors?

Women > 65 and Men > 70

46

What should be considered for women discontinuing estrogen?

Should be considered for bone density testing

47

Which men are at increased risk for osteoporosis and should have BMD testing done?

Age > 70. BMI < 20-25. > 10% weight loss. No physical activity on regular basis. Corticosteroid use. Androgen deprivation therapy. Previous fragility fracture

48

What are some characteristics of peripheral screening tests (lower arm, wrist, finger, heel)?

Help identify those most likely to benefit from further bone density testing. Cannot accurately diagnose osteoporosis. Should NOT be used to see how well osteoporosis medication is working. Results cannot be compared with results of central DXA. Bone density measurements from different devices cannot be directly compared. Need follow-up with healthcare provider to discuss need for additional testing, such as central DXA test of hip and/or spine

49

What are the characteristics of repeating bone density tests?

Best to use same testing equipment and have test done at same place each time. Taking osteoporosis medication (repeat central DXA every 1-2 years). After starting new osteoporosis medication (repeat BMD test after 1 year)

50

What is considered "normal" for postmenopausal caucasian women test results?

BMD within 1 SD of young adult mean value (T-score at or above -1)

51

What is considered "Low Bone Mass (Osteopenia)" for postmenopausal caucasian women test results?

BMD between 1 and 2.5 SD below young adult mean value (T-score between -1 and -2.5)

52

What is considered "Osteoporosis" for postmenopausal caucasian women test results?

BMD 2.5 SD or more below young adult mean value (T-score at or below -2.5)

53

What is considered "Severe Osteoporosis (Established Osteoporosis)" for postmenopausal caucasian women test results?

BMD 2.5 SD or more below young adult mean value in the presence of at least one fragility fracture

54

What does a T-score tell you?

Number of SDs from normal young adult mean bone density values of same gender

55

What does a Z-score tell you?

Number of SDs from normal mean value of same age and gender

56

What kind of score is preferred for postmenopausal women and men age 50 and older?

T-scores are preferred

57

What kind of score is preferred for females prior to menopause and males younger than age 50?

Z-scores, not T-scores, are preferred (particularly important in children). Osteoporosis cannot be diagnosed in men under age 50 on basis of BMD alone. Z-scores should be population specific where adequate reference data exist

58

What does a Z-score of -2.0 or lower mean?

Below the expected range for age

59

What does a Z-score above -2.0 mean?

Within the expected range for age

60

What is the WHO Fracture Risk Algorithm (FRAX)?

Calculates 10-year probability of hip fracture and 10-year probability of major osteoporotic fracture (e.g. vertebral, hip, forearm, humerus). Takes into account femoral neck BMD and risk factors. Most useful in patients with low hip BMD

61

What is US-FRAX done?

For postmenopausal women and men > 50 years. Not for use in younger adults or children. Applies only to previously untreated patients

62

What are the types of Osteoporosis treatments?

Antiresorptive (slow rate of bone loss). Anabolic (promote bone formation)

63

What are the goals of Osteoporosis treatment?

Prevent fractures. Stabilize or achieve an increase in bone mass. Relieve symptoms of fractures and skeletal deformity. Maximize physical function (e.g. halt progressive deformity)

64

What are the pharmacologic treatment options for Osteoporosis?

Estrogen and estrogen-progestin combination (no longer recommended as first-line therapy; estrogen protects bones). Estrogen agonist/antagonist (Raloxifene). Bisphosphonates (Aldendronate, Risedronate, Ibandronate, Zolendronic acid). Calcitonin. Recombinant parathyroid hormone (Teriparatide). RANK ligand inhibitor (Denosumab)

65

What are the non-pharmacologic interventions for everyone?

Adequate calcium and vitamin D. Good general nutrition. Exercise. Lifestyle (smoking cessation, limit alcohol). Fall prevention

66

Initiation of pharmacologic therapy recommended in the presence of what?

Clinical osteoporosis (hip or vertebral fracture). Osteoporosis by bone density (T-score < 2.5 at femoral neck or spine). FRAX assessment if T-score between -1.0 and -2.5 (10-year probability of major osteoporosis-related fracture > 20%, 10-year probability of hip fracture > 3%)

67

What are Estrogen Agonists/Antagonists?

Previously known as selective estrogen receptor modulators (SERMs). Bind to estrogen receptors. Exert estrogenic (agonist) effects on some tissue, while acting as anti-estrogens (antagonist) in other tissues. Tissues that possess estrogen receptors include: breast, uterus, bone, liver, vasculature, brain

68

What Estrogen agonist/antagonists are used for breast cancer?

Tamoxifen (Nolvadex). Raloxifene (Evista)

69

What is Tamoxifen (Nolvadex) used for?

1) Metastatic breast CA in women and men. 2) Adjuvant treatment of breast CA in women. 3) Reduce risk of invasive breast CA in women w/ ductal carcinoma in situ. 4) Reduce incidence of breast CA in high risk women

70

What is the risk of Tamoxifen (Nolvadex) use?

Hypercalcemia. Uterine malignancies. Stroke. Thromboembolic event. Pregnancy category D

71

What is Raloxifene (Evista) used for?

1) Reduce risk of invasive breast CA in postmenopausal women with osteoporosis. 2) Reduce risk of invasive breast CA in postmenopausal women at high risk for invasive breast CA. Not shown to reduce risk of noninvasive breast CA. Not indicated for treatment of invasive breast CA or reduction of risk of recurrence

72

What does Raloxifene (Evista) do to the bone?

Estrogen agonist in bone. Decrease bone resorption and bone turnover. Increase BMD. Decrease fracture incidence

73

What does Raloxifene (Evista) do to lipids?

Decrease serum total cholesterol, LDL levels. No effects on HDL levels. No cardiovascular benefit. Not for primary or secondary prevention of CV disease

74

What is the absorption/BA like for Raloxifene (Evista)?

Rapidly absorbed after oral administration; approximately 60% of oral dose absorbed, but extensive first-pass metabolism with glucuronide conjugation; absolute bioavailability 2%; primarily excreted in feces

75

What population is Raloxifen (Evista) indicated for treatment/prevention of osteoporosis?

In postmenopausal women (not recommended for premenopausal women, men not recommended, history of prior breast CA not studied)

76

How is Raloxifene (Evista) dosed?

One 60mg tablet daily at any time of day without regard to meals

77

What are the ADRs associated with Raloxifene (Evista)?

Hot flashes (most commonly during first 6 months). Leg cramps. Increased levels of TGs. Increased risk of venous thromboembolic events (greatest during first 4 months of therapy). Increased risk of death d/t stroke

78

When should Raloxifene (Evista) be discontinued to reduce risk venous thromboembolic events?

D/C 72 hours prior to and during prolonged immobilization (e.g. post-surgical recovery, prolonged bed rest); resume only after patient is fully ambulatory. Advise patient to move about periodically during prolonged travel (avoid prolonged restrictions of movement during travel)

79

What are the contraindications for Raloxifene (Evista)?

Active or past history of venous thromboembolic events, including: DVT, PE, Retinal vein thrombosis. Pregnancy, women who may become pregnant, nursing mothers (category X)

80

When should patients contact their physician when using Raloxifene (Evista)?

Pain in calves or leg swelling. Sudden chest pain or SOB. Changes in vision. Abnormal bleeding from vagina. Breast pain or enlargement. Pregnancy. Unexplained uterine bleeding. Unexplained breast abnormality

81

When should Raloxifene (Evista) be used with caution?

Hepatic impairment. Moderate or severe renal impairment

82

What is some patient counseling for Raloxifene (Evista)?

Consume adequate calcium, vitamin D; supplements if daily intake inadequate. Regular weight-bearing exercise. Reduce other risk factors for osteoporosis (cigarette smoking, excessive alcohol). Do not use if history of blood clots in veins, legs, lungs, or eyes; or if pregnant or nursing. Avoid taking concurrent estrogen therapy

83

What are Bisphosphonates?

Highly polar compounds; poorly absorbed in upper small intestine after oral ingestion; low BA. Absorption substantially reduced in presence of food (not not take with ANYTHING). Virtually all of absorbed dose is either taken up into bone or eliminated in urine

84

Can Bisphosphonates be used in renal impairment?

Elimination is deceased with impaired renal function; not recommended with severe renal impairment (CrCl < 30-35 mL/min

85

How are Bisphosphonates taken into bone?

Uptake by osteoclasts during bone resorption --> loss of resorptive function --> apoptosis of osteoclasts. Also reduces number of active osteoclasts by inhibiting their recruitment and inhibits osteoclast-stimulating activity by osteoblasts. Reduces bone resorption and turnover

86

What are the Bisphosphonates used?

Alendronate (Fosamax). Etidronate (Didronel). Pamidronate (Aredia). Risedronate (Actonel). Tiludronate (Skelid). Zoledronic Acid (Zometa, Reclast)

87

What are the indications for Alendronate (Fosamax) use?

Treatment of osteoporosis in postmenopausal women OR to increase bone mass in men with osteoporosis. Prevention of osteoporosis in postmenopausal women (half of treatment dose). Treat glucocorticoid-induced osteoporosis in men and women

88

How is Alendronate (Fosamax) dosed for the treatment of osteoporosis in postmenopausal women OR to increase bone mass in men with osteoporosis

One 70mg tab orally once weekly OR one bottle of 70mg oral solution once weekly OR one 10mg tablet orally once daily

89

How is Alendronate (Fosamax) dosed for prevention of osteoporosis in postmenopausal women

Half of treatment dose. One 35mg tablet orally once weekly OR one 5mg tablet orally once daily

90

How is Alendronate (Fosamax) dosed for treating glucocorticoid-induced osteoporosis in men and women (daily dosage equivalent of 7.5mg or greater of prednisone)?

One 5mg tablet orally once daily. EXCEPT, for postmenopausal women not receiving estrogen: one 10mg tablet orally once daily

91

What is Fosamax Plus D?

Alendronate sodium and cholecalciferol. Treatment of osteoporosis in postmenopausal women OR to increase bone mass in men with osteoporosis. Should not be used to treat vitamin D deficiency

92

How is Fosamax Plus D dosed?

Once weekly oral tablet, comes in two forms. 70mg alendronate & 2800 IU vitamin D3, 70mg alendronate & 5600 IU vitamin D3. For most osteoporotic women and men: appropriate dose is 70mg/5600 IU once weekly

93

What is a caution for Fosamax Plus D?

May worsen hypercalcemia and/or hypercalciuria when administered to patients with diseases associated with unregulated over production of vitamin D (e.g. leukemia, lymphoma, sarcoidosis): monitor urine and serum calcium

94

What are the indications for Risedronate (Actonel)?

Treatment of postmenopausal osteoporosis. Prevention of postmenopausal osteoporosis. Treatment to increase bone mass in men with osteoporosis. Treatment and prevention of glucocorticoid-induced osteoporosis in men and women (daily dosage equivalent to 7.5mg or greater of prednisone)

95

How is Risedronate (Actonel) dosed for the treatment of postmenopausal osteoporosis?

One 5mg tablet orally, taken daily OR one 35mg tablet orally, taken once a week OR one 150mg tablet orally, taken once a month

96

How is Risedronate (Actonel) dosed for prevention of postmenopausal osteoporosis?

Same as treatment

97

How is Risedronate (Actonel) dosed for treatment to increase bone mass in men with osteoporosis?

One 35mg tablet orally, taken once a week

98

How is Risedronate (Actonel) dosed for treatment and prevention of glucocorticoid-induced osteoporosis in men and women?

One 5mg tablet orally, taken daily

99

What is Risedronate DR (Atelvia) approved for?

Treatment of postmenopausal osteoporosis. One 35mg DR tablet orally, once a week

100

How should Risedronate DR (Atelvia) be taken?

Take immediately following breakfast and not under fasting conditions (significantly higher incidence of abdominal pain when taken before breakfast under fasting conditions)

101

What are some DDIs to look out for with Risedronate (Atelvia)?

Calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations interfere with absorption of Atelvia, take at different times. Concomitant administration of Atelvia and H2 blockers or PPIs is not recommened (increase in stomach pH can increase Atelvia BA)

102

What is Risedronate (Atelvia) like with renal insufficiency?

Not recommended for use when CrCl < 30

103

What is ORAL Ibandronate (Boniva) indicated for?

Treatment of postmenopausal osteoporosis. Prevention of postmenopausal osteoporosis

104

How is ORAL Ibandronate (Boniva) dosed for treatment of postmenopausal osteoporosis?

One 150mg tablet orally once monthly on same date each month

105

How is ORAL Ibandronate (Boniva) dosed for prevention of postmenopausal osteoporosis?

One 150mg tablet orally once monthly on same date each month

106

What is INJECTED Ibandronate (Boniva) indicated for?

Treatment of osteoporosis in postmenopausal women

107

How is INJECTED Ibandronate (Boniva) dosed for treatment of osteoporosis in postmenopausal women?

3mg dose, 15-30 second IV injection, administered once every 3 months; not more frequently

108

What are some guidelines for INJECTED Ibandronate (Boniva) use?

Must only be administered IV. Must be administered by a healthcare professional

109

What are some ADRs with INJECTED Ibandronate (Boniva)?

May cause transient decrease in serum calcium values. Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively treated before starting Boniva injection therapy

110

What must patients receive while on INJECTED Ibandronate (Boniva)?

Supplemental calcium and vitamin D

111

How is Zoledronic Acid (Reclast) dosed?

5mg IV infusion once a year. 5mg IV infusion once every 2 years

112

What is Zoledronic Acid (Reclast) dosed 5mg IV infusion once a year for?

Treatment of postmenopausal osteoporosis. Osteoporosis in men. Glucocorticoid-induced osteoporosis, treatment and prevention

113

What is Zoledronic Acid (Reclast) dosed 5mg IV infusion once every 2 years for?

Prevention of postmenopausal osteoporosis

114

How long should the Zoledronic Acid (Reclast) IV infusion take?

Must not be less than 15 minutes

115

What are some ADRs associated with Zoledronic Acid (Reclast)?

Acute phase reaction (fever, myalgia, flu-like symptoms, HA, arthralgia) after infusion; most occur within first 3 days following dose of Reclast; usually resolve within 3 days of onset but may last for up to 7-14 days

116

What can be given following administration of Zoledronic Acid (Reclast) to help reduce incidence of symptoms?

APAP. Symptoms decreased with subsequent doses

117

How is Zoledronic Acid (Reclast) use in renal impairment?

If history of physical signs suggest dehydration, withhold therapy until normovolemic status achieved. Use with caution in patients with chronic renal impairment. Reclast is contraindicated in patients with CrCl < 35 or in patients with evidence of acute renal impairment

118

What are some possible DDIs with Zoledronic Acid (Reclast)?

Aminoglycosides (may lower serum calcium for prolonged periods). Loop diuretics (may increase risk of hypocalcemia). Nephrotoxic drugs (such as NSAIDS): use with caution

119

What is the most common ADR assocaited with Bisphosphonates?

Gastrointestinal (abdominal pain, Dyspepsia, heartburn, esophageal irritation, erosive esophagitis. Ulcers of esophagus, stomach, duodenum. Nausea, vomiting. Diarrhea

120

Besides GI effects, what are some other ADRs associated with Bisphosphonates?

Decrease in serum calcium and phosphate may occur. Hypocalcemia can worsen and must be corrected before initiation of therapy. HA. Bronchoconstriction in aspirin-sensitive patients.

121

What are some Acute Phase Response ADRs associated with Bisphosphonates?

Fever, chills, bone pain, myalgias, arthralgias. Sometimes accompanies initial administration of IV bisphosphonates. May occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. Symptoms tend to resolve within several days with continued drug use

122

What is Ocular Inflammation with Bisphosphonate use?

Uveitis, nonspecific conjunctivitis, episcleritis, scleritis, iritis. Patients with vision loss or ocular pain should be referred to ophthalmologist. Bisphosphonates may need to be discontinued in order for ocular inflammation to resolve

123

What is Atrial Fibrillation with Bisphosphonate use?

Life-threatening, resulting in hospitalization or disability. Reclast: most surfaced more than 30 days after infusion. No clear association between overall bisphosphonate exposure and rate of serious or non-serious atrial fibrillation observed

124

What is Musculoskeletal pain with Bisphosphonate use?

Bone, muscle, joint pain. Severe and sometimes incapacitating pain. May occur within days, months, or years after starting bisphosphonate. Consider temporary or permanent discontinuation of drug

125

What is Bisphosphonate-associated Osteonecrosis of Jaw (ONJ)?

Encourage patients to inform their dentist that they are taking bisphosphonates. Patients encouraged to maintain good oral hygiene and to have regular dental visits during which they can be instructed in proper dental hygiene. Usually occurs with long-term (> 3 years) oral bisphosphonates

126

What 3 characteristics are present in Bisphosphonate-Related Osteonecrosis of the Jaw (BRONJ)?

Current or previous treatment with a bisphosphonate. Exposed bone in the maxillofacial region that has persisted for more than 8 weeks. No history of radiation therapy to the jaws

127

What are some Atypical Fractures?

Thigh or groin pain (femoral fracture). Tibia. Pelvis. Metatarsals. Ulna

128

With oral bisphosphonates, how long much you wait to eat or drink something or take other medications or lie down?

At least 30 minutes after Aldendronate and Risedronate. At least 60 minutes after Ibandronate

129

What is unique about taking Atelvia compared to other bisphosphonates?

Take AFTER breakfast, at least 4 ounces of plain water

130

When should oral bisphosphonates be avoided?

Have problems with esophagus. Unable to stand or sit upright for at least 30-60 minutes. Temporarily bedridden. Severe renal insufficiency. Pregnancy, lactation

131

What should be done with a missed dose of the ONCE DAILY bisphosphonates?

If patient forgets to take tablet in morning, DO NOT take it later in the day; just return to normal schedule and take one tablet the next morning. DO NOT take two tablets on same day

132

What should be done with a missed dose of the ONCE WEEKLY bisphosphonates?

Take one tablet on morning after remembering and return to taking one tablet once a week as originally scheduled on chosen day. DO NOT taken two tablets on same day

133

What should be done with a missed dose of the ONCE MONTHLY bisphosphonates?

If next scheduled dosing day is more than 7 days away, take one tablet in morning following the date that it is remembered; then return to taking one tablet every month the morning of originally scheduled dosing day of the month. DO NOT take two monthly tablets within 7 days (if next scheduled dosing day is within 7 days, wait until next scheduled dosing day)

134

What are some things you should tell patients to do while on Bisphosphonates?

Take supplemental calcium and vitamin D if daily dietary intake is inadequate. Weight-bearing exercise. Decrease cigarette smoking, alcohol consumption

135

What are the CrCl cutoffs for Bisphosphonate use?

CrCl < 30: Risedronate, Ibandronate, Tiludronate (RIT). CrCl < 35: Alendronate, Zoledronic Acid

136

Whats the relation between bisphosphonates and UGIs?

Caution with active UGI problems (dysphagia, symptomatic esophageal diseases, gastritis, duodenitis, ulcers)

137

What is Calcitonin?

Endogenous inhibitor of bone resorption by decreasing osteoclast formation

138

When is Calcitonin recommended?

Treatment of postmenopausal osteoporosis in women (greater than 5 years after menopause, who refuse or cannot tolerate estrogens OR in whom estrogens are contraindicated or are not an option). May also be used in patients unable to take bisphosphonates due to malabsorption, esophagitis predisposition, GI upset. Associated with analgesic effect in acute compression fractures

139

What are the Calcitonin-Salmon Nasal Spray drugs?

Miacalcin. Fortical (rDNA origin)

140

How is Calcitonin-Salmon Nasal Spray dosed?

One spray (200 IU, 0.09mL) per day, intranasally. Administer in alternate nostrils daily. Take with adequate calcium (at least 1000mg elemental Ca and 400 IU Vitamin D)

141

What are the ADRs associated with Calcitonin-Salmon Nasal Spray?

Nasal symptoms (periodic nasal exams recommended): rhinitis, epistaxis (nosebleed), nasal ulceration, nasal congestion. Joint pain. HA

142

What is some important patient counseling for Calcitonin-Salmon Nasal Spray?

Keep track of number of doses used from each bottle. After 30 doses, each spray may not deliver the correct amount of medication, even if the bottle is not completely empty. Prime before use of new bottle

143

What is Calcitonin-Salmon INJECTION (Miacalcin) used for?

Treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated.

144

What is Parathyroid Hormone (PTH)?

Low calcium level --> increased PTH secretion: Increases calcium release from bone, directly increases renal tubular calcium reabsorption. Indirectly enhances intestinal calcium absorption

145

How can continuous administration and low-dose intermittent administration of PTH alter its effects?

Continuous administration or high circulating levels: bone resorption stimulated more than bone formation --> bone demineralization and osteopenia (catabolic effect). Low-dose intermittent administration by daily injection: bone growth (anabolic effect), in part by preventing osteoblast apoptosis

146

What is Teriparatide (rDNA origin) injection (Forteo)?

Recombinant hPTH fragment. Stimulates new bone formation on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. Increases osteoblast birth rate and prevents osteoblastic apoptosis --> increases number of osteoblasts and rate of new bone formation, and prolong osteoblast survival. First anabolic agent available to treat osteoporosis

147

What are the indications for Teriparatide (Forteo)?

Treatment of postmenopausal women with osteoporosis at high risk of fracture. Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture. Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy

148

How is Teriparatide (Forteo) dosed?

Disposable pen device for subcutaneous injection; each cartridge has 28 day supply. Discard after 28 days. Dose: 20 mcg once a day, SC injection into thigh or abdominal wall

149

What is the BBW associated with Teriparatide (Forteo)?

Increased incidence of osteosarcoma (malignant bone tumor). Should not be prescribed for patients at increased baseline risk for osteosarcoma (i.e. Paget's disease of bone)

150

What are the precautions for Teriparatide (Forteo) use?

Use for more than 2 years during a patients lifetime is not recommended

151

What is some patient education for Teriparatide (Forteo)?

Role of supplemental Ca and/or vitamin D, weight-bearing exercise, no smoking/alcohol. Administer initially under circumstances where patient can immediately site or lie down if orthostatic hypotension symptoms occur. Store pen under refrigeration AT ALL TIMES

152

What are some ADRs with Teriparatide (Forteo) use?

Nausea, dizziness, leg cramps

153

What is Denosumab (Prolia)?

RANK Ligand (RANKL) Inhibitor. RANKL is essential for formation, function, and survival of osteoclasts. RANKL Inhibitors prevent RANKL from activating its receptor on the surface of osteoclasts and their precursors

154

What is Denosumab (Prolia) used for?

Treatment of postmenopausal women with osteoporosis at high risk for fracture. To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

155

How is Denosumab (Prolia) dosed?

60mg every 6 months, SC injection in upper arm, upper thigh, or abdomen; administered by healthcare professional. Calcium 1000mg and at least 400 IU vitamin D daily

156

What is the contraindication for Denosumab (Prolia) use?

Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia

157

What are the most common ADRs associated with Denosumab (Prolia)?

Back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, cystitis; pancreatitis

158

What do patients using Denosumab (Prolia) need to be enrolled in?

Pregnancy category X: may cause fetal harm; contraindicated in women who are pregnant. Enroll in Amgen's Pregnancy Surveillance Program

159

What has Calcium and Vitamin D shown not to do in menopause?

Does not appear to prevent the accelerated bone loss that occurs during the first 5-7 years of menopause

160

When should a patient be considered for referral to specialist?

Has osteoporosis that is unexpectedly severe or has unusual features at time of initial assessment (very low BMD (T-score < -3.0 or Z-score < -2.0), osteoporosis despite young age, fractures despite borderline or normal BMD)

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What are three questions that should be asked to younger post-menopausal women (50-64) who don't have daignosed osteoporosis?

1) Is there a prior history of fractures 2) Does the patient have BMD T-score of nor more than -1.1. 2) Does the patient report herself to be in poor or fair general health