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PHRM 825 - Exam 4 > LECTURE 41 & 42: therapeutics of osteoporosis > Flashcards

LECTURE 41 & 42: therapeutics of osteoporosis Flashcards

1
Q

List bisphosphonate drug options

A

alendronate (Fosamax, Binosto)
risedronate (Actonel, Atelvia)
ibandronate (Boniva)
zoledronic acid (Reclast)

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2
Q

List the indications for the use of bisphosphonates

A
  • Treatment and prevention of postmenopausal osteoporosis
  • Treatment of osteoporosis to increase bone mass in males
  • Treatment of glucocorticoid-induced osteoporosis in males and females
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3
Q

List the contraindications for the use of bisphosphonates

A
  • Hypocalcemia
  • Renal insufficiency (CrCl < 30-35 ml/min)
  • Esophageal abnormalities (except IV formulations)
  • Inability to sit or stand for at least 30 minutes (at least 60 minutes for ibandronate)
  • Avoid alendronate oral solution in patients at risk for aspiration
  • Avoid oral bisphosphonate after bariatric surgery
  • Pregnancy or breast-feeding (IV zoledronic acid)
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4
Q

List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of alendronate

A

vertebral - 43%
hip - 39%
non-vertebral - 16%

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5
Q

List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of risedronate

A

vertebral - 39%
hip - 27%
non-vertebral - 22%

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6
Q

List the risk reduction percentage (vertebral, hip, non-vertebral) of zoledronic acid

A

vertebral - 62%
hip - 40%
non-vertebral - 21%

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7
Q

List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of ibandronate

A

vertebral - 33%
hip & non-vertebral - n/a

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8
Q

List the adverse effects of bisphosphonates

A
  • Esophageal irritation/ulceration (1.5%)
  • Abdominal pain (1.9% - 6.6%)
  • Musculoskeletal pain
  • Headache
  • Nausea
  • Atypical thigh fracture (< 1%)
  • Ocular inflammation: conjunctivitis, uveitis, episcleritis and scleritis (0.08%)
  • Osteonecrosis of the jaw (ONJ)
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9
Q

List the RANK ligand inhibitor drug options

A

denosumab (Prolia)

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10
Q

List the indications of RANK ligand inhibitors

A

Treatment of osteoporosis in men and postmenopausal women who are at high risk for fractures
– Treat bone loss in women with breast cancer on aromatase inhibitor therapies
– Failed or intolerant to other therapy

Glucocorticoid-induced osteoporosis in men and women

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11
Q

List the contraindications for RANK ligand inhibitors

A

Hypocalcemia

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12
Q

List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of denosumab

A

Vertebral → 68%
Hip → 44%
Non-Vertebral → 20%

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13
Q

Explain the rebound effects of denosumab

A

Increased risk of vertebral fracture after discontinuation

  • Consider indefinite treatment of __
  • For exit strategy: consider __ (to prevent rapid bone loss and fracture) after discontinuation of denosumab
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14
Q

Describe the black box warning for denosumab

A

Severe hypocalcemia in patients with advanced kidney disease

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15
Q

List the common side effects for denosumab

A

Back pain
High cholesterol
Musculoskeletal pain
Bladder infection, UTI

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16
Q

List the serious side effects for denosumab

A

Dermatitis, cellulitis, rash eczema
Hypocalcemia
Serious infections
Osteonecrosis of the jaw (ONJ)
Atypical femur fractures

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17
Q

List the SERM drug options

A

Raloxifene (Evista)
Bazedoxifene + conjugated estrogens (Duavee)

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18
Q

List the indications for Raloxifene (Evista)

A
  • Prevention and treatment of postmenopausal osteoporosis
  • Breast cancer prophylaxis for postmenopausal women at high risk
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19
Q

List the indications for Bazedoxifene + conjugated estrogens (Duavee)

A

Prevention in postmenopausal women with a uterus

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20
Q

List the contraindications for SERMs

A
  • Active or past history of venous thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis)
  • Pregnancy or lactating
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21
Q

List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of raloxifene

A

Vertebral → 41%
Hip & Non-Vertebral → NS

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22
Q

List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of bazedoxifene

A

Vertebral → 39%
Hip & Non-Vertebral → NS

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23
Q

Describe the black box warning for raloxifene

A

Increased risk of DVT and pulmonary embolism (PE)
Increased risk of stroke

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24
Q

List the common side effects of raloxifene

A

Hot flashes
Leg cramps
Weight gain
Peripheral edema

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25
List the indications for Calcitonin (salmon-calcitonin)
- Treatment of postmenopausal osteoporosis in women > 5 years menopause - Has analgesic effects for acute and chronic pain associated with vertebral fracture
26
List the contraindications for calcitonin (salmon-calcitonin)
Allergy to salmon-calcitonin
27
List the warnings/precautions for calcitonin (salmon-calcitonin)
- Hypercalcemia - Orthostatic hypotension - Patient with increased incidence of osteosarcoma (malignant bone tumor)
28
What is the fracture prevention efficacy for calcitonin (salmon-calcitonin)?
33% risk reduction for **vertebral** fracture
29
List the intranasal adverse effects of calcitonin (salmon-calcitonin)
Rhinitis Epistaxis Dryness Nasal irritation Increased cancer risk (prostate & liver)
30
List the subcutaneous adverse effects of calcitonin (salmon-calcitonin)
Flushing (vasomotor symptoms) Nausea Rash Allergic reaction
31
List the parathyroid hormone drug options
Teriparatide (Forteo, Bonsity) Abaloparatide (Tymlos)
32
List the indications for parathyroid hormones
Women: Treatment of postmenopausal osteoporosis who are at very high risk for fractures Men: Increase bone mass in men with primary osteoporosis or osteoporosis associated with hypogonadism, who are at high risk for fractures Teriparatide only (glucocorticoid-induced osteoporosis in men and women) **Very “high risk” candidates** - History of osteoporotic fracture - Multiple risk factors for fracture - Extremely low BMD (T-score below -3.5) without fragility fracture - Failed or intolerant to other osteoporosis therapy
33
List the contraindications for parathyroid hormone use
Hypersensitivity (eg, anaphylaxis, angioedema) to teriparatide/abaloparatide or any component of the formulation
34
List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of teriparatide
Vertebral → 73% Hip → 0% Non-Vertebral → 38%
35
List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of abaloparatide
Vertebral → 86% Hip → 0% Non-Vertebral → 49%
36
List the adverse effects of parathyroid hormones
- Dizziness - Orthostatic hypotension (administer when patient may sit/lie down) - Nausea - Leg cramps - Arthralgias (joint pain) - Hypercalciuria - Hypercalcemia (decrease Ca intake
37
What is the lifetime duration for teriparatide?
2 years *repeat allowed in appropriate patient*
38
What is the lifetime duration for abaloparatide?
18 months
39
List the drug options for monoclonal anti-sclerostin antibody
romosozumab (Evenity®)
40
List the indications for the use of romosozumab (Evenity®)
Treatment of osteoporosis in postmenopausal women who are at high risk for fractures: - History of osteoporotic fracture - Multiple risk factors for fracture - Extremely low BMD (T-score below -3.5) without fragility fracture - Failed or intolerant to other osteoporosis therapy
41
List the contraindications for romosozumab (Evenity®) use
Uncorrected hypocalcemia
42
List the fracture risk reduction percentage (vertebral, hip, non-vertebral) of romosozumab
Vertebral → 67% Hip → 56% Non-Vertebral → 33%
43
What is an important point to keep in mind when considering d/c romosozumab?
Discontinuation of romosozumab results in bone loss and return of BMD to pre-treatment levels Consider… subsequent treatment with bisphosphonate or denosumab
44
List adverse effects of romosozumab
- Headache - Hypocalcemia - Arthralgias (joint pain) - Injection site reactions
45
What is the black box warning for romosozumab?
Increased risk of MI, stroke, or CV death
46
What is the maximum lifetime duration for romosozumab?
12 months
47
List drugs that have some degree of efficacy for VERTEBRAL fracture risk reduction
calcitonin estrogen (+/-) progesterone raloxifene (Evista) bazedoxifene ibandronate alendronate (Fosamaz) risedronate (Actonel) zoledronic acid (Reclast) denosumab (Prolia) teriparatide (Forteo) abaloparatide (Tymlos) romosozumab (Evenity)
48
List drugs that have some degree of efficacy for HIP fracture risk reduction
estrogen (+/-) progesterone alendronate (Fosamaz) risedronate (Actonel) zoledronic acid (Reclast) denosumab (Prolia) romosozumab (Evenity)
49
List drugs that have some degree of efficacy for NON-VERTEBRAL fracture risk reduction
estrogen (+/-) progesterone alendronate (Fosamaz) risedronate (Actonel) zoledronic acid (Reclast) denosumab (Prolia) teriparatide (Forteo) abaloparatide (Tymlos) romosozumab (Evenity)
50
List patient counseling points for oral bisphosphonates regarding how to correctly take the medications
Strict administration guidelines! - Must be taken on an empty stomach – 1st thing in the morning (exception - delayed release risedronate) - Drink a full glass of **plain water** (6-8 oz) for tablet (at least 2oz for oral solution, avoid mineral water) - Do NOT lie down for at least 30 minutes after ingestion AND until after 1st food of the day (60 minutes for ibandronate) - Do NOT chew
51
When should oral bisphosphonates be d/c?
If pt experiences: Dysphagia (difficulty swallowing) Odynophagia (painful swallowing) Retrosternal pain Heartburn
52
List drug interactions for oral bisphosphonates
Chelates with multivalent cations (antacids, mineral supplements, vitamins, osmotic laxatives) Increased GI side effects with NSAIDs
53
What (non-oral) drugs require patient counseling for administration?
SUBQ: Romosozumab Calcitonin (also IM) Denosumab Parathyroid hormones Intranasal: Calcitonin
54
List the criteria to be considered "high risk" for fractures
- History of osteoporotic fracture - Multiple risk factors for fracture - Extremely low BMD (T-score below -3.5) without fragility fracture - Failed or intolerant to other osteoporosis therapy
55
Which drugs are contraindicated in patients with a eGFR < 35 mL/min/1.73m^2?
alendronate risedronate ibandronate
56
Which drugs should be used cautiously in patients with a eGFR < 35 mL/min/1.73m^2?
raloxifene, bazedoxifene teriparatide
57
Which drug, if taken by a patient with severe renal dysfunction, could cause hypercalcemia?
denosumab
58
Which drugs are considered "first-line"?
Alendronate Risedronate Zoledronic acid Denosumab
59
Which drugs are considered "second-line"?
ibandronate
60
Which drugs are considered "third-line"?
Raloxifene
61
Which drugs are considered "fourth-line"?
Calcitonin
62
Which drugs are considered "last-line"?
Parathyroid hormone
63
List some monitoring parameters used to evaluate treatment of osteoporosis
Bone mineral density (BMD) Renal Function Serum Calcium 25-hydroxyvitamin D levels
64
After how long should a prescriber consider taking a patient off of oral bisphosphonates?
consider stopping after 5 years
65
After how long should a prescriber consider taking a patient off of IV bisphosphonates?
consider stopping after 3 years
66
How often should DXA scans be taken to measure changes in BMD?
1-3 years after initial therapy consider less frequent monitoring once BMD is stable/improved
67
How does BMD indicate successful treatment?
If the BMD is stable or increasing with no evidence of new fractures or fracture progression (BMD differences 3-5% are clinically significant)
68
How often should lab values be measured? (renal function, serum calcium, 25-hydroxyvitamin D levels)
every 1-2 years
69
What is the recommended elemental calcium intake for women?
Age 19 & younger (pregnant / lactating) 1,300 mg daily Age 20 & older (pregnant / lactating) 1,000 mg daily Ages 50 & younger 1,000 mg daily Age 51 & older 1,200 mg daily
70
What is the recommended elemental calcium intake for men?
Age 70 & younger 1,000 mg daily Age 71 & older 1,200 mg daily

PHRM 825 - Exam 4 (4 decks)

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