Pharmacotherapy Osteoporosis Dr. Dowling Flashcards

EXAM 2

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1
Q

What are the major risk factors for Osteoporosis?

A

-Advanced age
-Current smoker
-History of fracture (after age 50)
-Excessive alcohol intake

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2
Q

What is the recommended daily Calcium intake for males and females?

A

male:
19-70y: 1000 mg daily
>71y: 1200 mg daily

female:
19-50y: 1000 mg daily
51-70y: 1200 mg daily

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3
Q

What is the recommended daily Vitamin D intake for males and females?

A

male:
<70y: 600 mg
>70y: 800 mg

female:
<70y: 600 mg
>70y: 800 mg

800-1000 mg for adults with osteoporosis

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4
Q

What is the maximum dose of Ca2+ supplement intake?

A

500 mg
better absorption with a lower dose
-dietary intake should be prioritized first

ADE: GI, constipation, potential for kidney stones (rare)

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5
Q

Dietary Calcium Intake Calculation

A

add a zero to the % value
ex: 30% = 300 mg
25% = 250 mg

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6
Q

How much % elemental calcium do the Ca2+ formulations contain?

A

Calcium Carbonate: 40% -> preferred
but requires an acidic environment

Calcium citrate: 21%

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7
Q

In which patient population is the Calcium Citrate formulation preferred?

A

-elderly
-patients with acid suppression
-those not taking it with meal

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8
Q

How to convert % Vitamin D to units?

A

multiply by 4

25% Vitamin D -> 100 U

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9
Q

What is the treatment serum goal of Vitamin D?

A

> 30 ng/dl
Vitamin D3 may have a better absorption (recommend D3 if possible)

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10
Q

What is the starting dose of Vitamin D supplementation?

A

5000U for 8-12 weeks (bc it takes about 3 months to reach steady state and reach the target)

->then change to a maintenance dose of 1000-2000 units daily

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11
Q

What is the gold standard for the diagnosis and severity of osteoporosis (BMD testing)?

A

Central DXA scan
T-score displays the severity

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12
Q

Which body parts are preferred to be checked with the DXA scan?

A

Hip
femoral neck
lumbar spine
distal 1/3 of radius

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13
Q

Which other device is used to screen the bone density?

A

Peripheral bone density device (Quantitative Ultrasonography)

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14
Q

What is the recommended age for BMD testing in women?

A

DMX testing for women 65 and older
OR
younger post-menopausal with
hx of fractures without trauma
3 or more months of glucocorticoids

(Evaluate individual risk factors in men ≥ 50 years)

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15
Q

How are the DMX scan results evaluated?

A

T-score: compare BMD to an average BMD of a healthy, sex-matched, 20-29yo white reference population

Z-score: compare BMD to an average BMD of a healthy, age-matched, sex-matched, ethnicity-matched population

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16
Q

Which score is used clinically to diagnose osteoporosis?

A

T-score

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17
Q

When is the Z-score used?

A

in patients with secondary osteoporosis
-> comorbidity, medicine-used osteoporosis, younger than 65, children)

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18
Q

When is a patient considered to have Osteopenia?

A

T-score between -1 to -2.5

below -2.5 –> Osteoporosis
+1 to -1 –> Normal

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19
Q

What are examples of medication-induced osteoporosis?

A

-Long-term glucocorticoids
-Antiepileptics (carbamazepine, phenytoin)
-some chemotherapy drugs

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20
Q

What is the dose and duration of glucocorticoids that is considered to increase the risk of osteoporosis?

A

> 5mg prednisone equivalent daily

3 months or more

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21
Q

What is considered high risk based on the FRAX score?

A

10-year major fracture risk > 20%

10-year hip fracture risk > 3%

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22
Q

What are the limitations of the FRAX score?

A

only estimates the risk for about half of fragility fractures

underestimates risk in the most severe cases

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23
Q

Who is eligible for pharmacotherapy to treat osteoporosis?

A

postmenopausal women and men 50 & over who:

-have a low-trauma fracture
-T-score of -2.5 or lower -> diagnosis of osteoporosis
-T-score of -1 to -2.5 (osteopenia) and a high fracture risk through assessment such as FRAX

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24
Q

What is the first-line treatment for Osteoporosis?

A

Bisphosphonates

Alendronate (PO)
Ibandronate (PO, IV)
Risedronate (PO)
Zoledronic acid (IV)

25
Q

Indication for Bisphosphonate

A

Treatment: Osteoporosis
Postmenopausal women
men (except Ibandronate)

Prevention of Osteoporosis
postmenopausal women

26
Q

How should bisphosphonates be taken?

A

-take in the morning on an empty stomach
-take with 6-8oz of water
-sit upright for 30 minutes (ibandroante: 60 min) -> due to GI and esophageal side effects

-> due to poor oral bioavailability <1%

27
Q

What are the side effects of Bisphosphonates?

A

GI upset and irritation
Atypical femoral fracture (AFF, rare) - a fraction on a spot of the femur that is unusual in osteoporosis
Osetonecrosis of the jaw (ONJ, rare)

28
Q

Contraindications for Bisphosphonate

A

-Esophageal abnormalities
-Hypocalcemia
-CrCl < 35

29
Q

How long is the duration of therapy with Bisphosphonates?

A

consider discontinuing after 5 years if:
-BMD is stable
-no fractures
-short-term fracture risk is low (no environment with activities that increase risk for a fracture)

30
Q

What should be monitored in patients taking Bisphosphonate?

A

BMD every 1 to 3 years
calcium and vitamin D
adherence
AFF and ONJ

31
Q

What should be taken care of before starting Denosumab?

A

correct for hypocalcemia (also for Romosozumab)

-> administered SubQ every 6 months by a health care provider

32
Q

Risk mitigating intervention for Denosumab

A

REMS program: make provider and patient aware of ADE:
-hypocalcemia
-AFF
-ONJ
-serious infection
-dermatologic reactions

33
Q

What should be monitored in patients taking Denosumab?

A

BMD every 1 to 3 years,
serum calcium and vitamin D, signs
of AFF or ONJ, pregnancy status

34
Q

Contrainidcations for Denosumab

A

Hypocalcemia

Pregnancy!!

35
Q

Duration of therapy for Denosumab

A

not established
if risk is still high after 5-10 years -> consider extending therapy or switch to Bisphosphonate

36
Q

What is the indication for Raloxifen? (SERM)

A

Treatment and prevention in postmenopausal women

37
Q

What is the indication for Bazedoxifene + CEE (Duavee®)? (SERM)

A

Prevention in postmenopausal women

38
Q

When to avoid Raloxifen?

A

Raloxifen should not be combined with additional systemic estrogens

39
Q

When to avoid Duavee?

A

avoid in women >60 years old or >10 years postmenopausal

40
Q

What is the BBW for SERMs

A

Increased risk of VTE, stroke

41
Q

What is the indication for Estrogen replacement drugs?

A

Prevention of osteoporsis in postmenopausal women

42
Q

When are Estrogen replacements considered?

A

When women are menopausal and have menopausal symptoms: vasomotor symptoms, systemic symptoms: hot flashes, night sweats

ex: Climara, Estrace, Prempro, Vivelle

43
Q

What is the indication of Calcitonin?

A

Treatment of Osteoporosis in postmenopausal women
-may help short-term in vertebral fracture pain
-daily nasal spray

ADE: rhinitis, runny nose, Antibody development (may decrease the effect)

44
Q

When to consider Calcitonin?

A

5 years postmenopausal women

45
Q

Indication for PTH analogs
-paratides

A

Teraparatide:
Treatment in postmenopausal women and men

Abaloparatide:
only men

they are ANABOLIC - so involved in building bone mass (not just preventing bone loss)

46
Q

How are PTH analogs administered?

A

-daily SubQ by the patient for up to 24 months (max 2 years lifetime exposure)

47
Q

ADE for PTH analogs

A

-orthostatic hypotension (sit or lie down when administering the drug)
-injection site reaction
-dizziness
-GI
-joint pain, leg cramps, headache
-Hypercalcemia, hyperuricemia (kidney stones, gout)!!!

48
Q

Monitor PTH analogs

A

-BMD every 1-2 years
-serum calcium
-urinary calcium if prone to kidney stones or
hypercalciuria

49
Q

Which drug is an Antiresorptive and Anabolic?

A

Romosozumab
-monthly SubQ by provider
-limit: 12 months

correct hypocalcemia before start!!!

50
Q

What is the BBW for Romosozumab?

A

increased risk of MI, stroke, and CV death

51
Q

Max duration for Romosozumab?

A

1 year
then change to antiresorptive

52
Q

Contraindications for Romosozumab

A

Hypocalcemia
recent MI or stroke within 1 year

53
Q

Monitor Romosozumab

A

BMD at baseline and after 6-12 months
serum calcium
signs for AFF and ONJ

54
Q

What are the first-line options of therapy?

A

Bisphosphonate -> if not possible (can’t swallow and IV is not possible) -> use Denosumab

55
Q

When is anabolic use considered?

A

severe case, and very high risk for fracture
-start with anabolic for short-term use and consider switching to antiresorptive

56
Q

What are the very high risk factors for fracture

A

T-score: <-3.0
FRAX Major fracture >30%
FRAX Hip fracture >4.5%

Fracture…
Within past 12 months
While on osteoporosis therapy
While on meds causing skeletal harm
(e.g., long-term glucocorticoids)

Hx of multiple osteo fractures
High risk/history of injurious falls

57
Q

When might a combo therapy be considered?

A

2 antiresorptives in a patient with bone loss and already using:
hormone therapy for menopause
or
Raloxifene for cancer

-using 2 drugs with different mechanisms is not recommended due to side effects

58
Q

Drugs appropriate for men

A

Bisphosphonate (antiresorptive)
Denosumab (antiresorptive)
Teriparatide - PTH analog (anabolic)

59
Q

Which drug cause hypercalcemia, hyperuricemia (uric acid in urine)?

A

PTH analogs