Pharmacotherapy Osteoporosis Dr. Dowling Flashcards
EXAM 2
What are the major risk factors for Osteoporosis?
-Advanced age
-Current smoker
-History of fracture (after age 50)
-Excessive alcohol intake
What is the recommended daily Calcium intake for males and females?
male:
19-70y: 1000 mg daily
>71y: 1200 mg daily
female:
19-50y: 1000 mg daily
51-70y: 1200 mg daily
What is the recommended daily Vitamin D intake for males and females?
male:
<70y: 600 mg
>70y: 800 mg
female:
<70y: 600 mg
>70y: 800 mg
800-1000 mg for adults with osteoporosis
What is the maximum dose of Ca2+ supplement intake?
500 mg
better absorption with a lower dose
-dietary intake should be prioritized first
ADE: GI, constipation, potential for kidney stones (rare)
Dietary Calcium Intake Calculation
add a zero to the % value
ex: 30% = 300 mg
25% = 250 mg
How much % elemental calcium do the Ca2+ formulations contain?
Calcium Carbonate: 40% -> preferred
but requires an acidic environment
Calcium citrate: 21%
In which patient population is the Calcium Citrate formulation preferred?
-elderly
-patients with acid suppression
-those not taking it with meal
How to convert % Vitamin D to units?
multiply by 4
25% Vitamin D -> 100 U
What is the treatment serum goal of Vitamin D?
> 30 ng/dl
Vitamin D3 may have a better absorption (recommend D3 if possible)
What is the starting dose of Vitamin D supplementation?
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
What is the gold standard for the diagnosis and severity of osteoporosis (BMD testing)?
Central DXA scan
T-score displays the severity
Which body parts are preferred to be checked with the DXA scan?
Hip
femoral neck
lumbar spine
distal 1/3 of radius
Which other device is used to screen the bone density?
Peripheral bone density device (Quantitative Ultrasonography)
What is the recommended age for BMD testing in women?
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)
How are the DMX scan results evaluated?
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
Which score is used clinically to diagnose osteoporosis?
T-score
When is the Z-score used?
in patients with secondary osteoporosis
-> comorbidity, medicine-used osteoporosis, younger than 65, children)
When is a patient considered to have Osteopenia?
T-score between -1 to -2.5
below -2.5 –> Osteoporosis
+1 to -1 –> Normal
What are examples of medication-induced osteoporosis?
-Long-term glucocorticoids
-Antiepileptics (carbamazepine, phenytoin)
-some chemotherapy drugs
What is the dose and duration of glucocorticoids that is considered to increase the risk of osteoporosis?
> 5mg prednisone equivalent daily
3 months or more
What is considered high risk based on the FRAX score?
10-year major fracture risk > 20%
10-year hip fracture risk > 3%
What are the limitations of the FRAX score?
only estimates the risk for about half of fragility fractures
underestimates risk in the most severe cases
Who is eligible for pharmacotherapy to treat osteoporosis?
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
What is the first-line treatment for Osteoporosis?
Bisphosphonates
Alendronate (PO)
Ibandronate (PO, IV)
Risedronate (PO)
Zoledronic acid (IV)
Indication for Bisphosphonate
Treatment: Osteoporosis
Postmenopausal women
men (except Ibandronate)
Prevention of Osteoporosis
postmenopausal women
How should bisphosphonates be taken?
-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%
What are the side effects of Bisphosphonates?
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)
Contraindications for Bisphosphonate
-Esophageal abnormalities
-Hypocalcemia
-CrCl < 35
How long is the duration of therapy with Bisphosphonates?
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)
What should be monitored in patients taking Bisphosphonate?
BMD every 1 to 3 years
calcium and vitamin D
adherence
AFF and ONJ
What should be taken care of before starting Denosumab?
correct for hypocalcemia (also for Romosozumab)
-> administered SubQ every 6 months by a health care provider
Risk mitigating intervention for Denosumab
REMS program: make provider and patient aware of ADE:
-hypocalcemia
-AFF
-ONJ
-serious infection
-dermatologic reactions
What should be monitored in patients taking Denosumab?
BMD every 1 to 3 years,
serum calcium and vitamin D, signs
of AFF or ONJ, pregnancy status
Contrainidcations for Denosumab
Hypocalcemia
Pregnancy!!
Duration of therapy for Denosumab
not established
if risk is still high after 5-10 years -> consider extending therapy or switch to Bisphosphonate
What is the indication for Raloxifen? (SERM)
Treatment and prevention in postmenopausal women
What is the indication for Bazedoxifene + CEE (Duavee®)? (SERM)
Prevention in postmenopausal women
When to avoid Raloxifen?
Raloxifen should not be combined with additional systemic estrogens
When to avoid Duavee?
avoid in women >60 years old or >10 years postmenopausal
What is the BBW for SERMs
Increased risk of VTE, stroke
What is the indication for Estrogen replacement drugs?
Prevention of osteoporsis in postmenopausal women
When are Estrogen replacements considered?
When women are menopausal and have menopausal symptoms: vasomotor symptoms, systemic symptoms: hot flashes, night sweats
ex: Climara, Estrace, Prempro, Vivelle
What is the indication of Calcitonin?
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)
When to consider Calcitonin?
5 years postmenopausal women
Indication for PTH analogs
-paratides
Teraparatide:
Treatment in postmenopausal women and men
Abaloparatide:
only men
they are ANABOLIC - so involved in building bone mass (not just preventing bone loss)
How are PTH analogs administered?
-daily SubQ by the patient for up to 24 months (max 2 years lifetime exposure)
ADE for PTH analogs
-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)!!!
Monitor PTH analogs
-BMD every 1-2 years
-serum calcium
-urinary calcium if prone to kidney stones or
hypercalciuria
Which drug is an Antiresorptive and Anabolic?
Romosozumab
-monthly SubQ by provider
-limit: 12 months
correct hypocalcemia before start!!!
What is the BBW for Romosozumab?
increased risk of MI, stroke, and CV death
Max duration for Romosozumab?
1 year
then change to antiresorptive
Contraindications for Romosozumab
Hypocalcemia
recent MI or stroke within 1 year
Monitor Romosozumab
BMD at baseline and after 6-12 months
serum calcium
signs for AFF and ONJ
What are the first-line options of therapy?
Bisphosphonate -> if not possible (can’t swallow and IV is not possible) -> use Denosumab
When is anabolic use considered?
severe case, and very high risk for fracture
-start with anabolic for short-term use and consider switching to antiresorptive
What are the very high risk factors for fracture
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
When might a combo therapy be considered?
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
Drugs appropriate for men
Bisphosphonate (antiresorptive)
Denosumab (antiresorptive)
Teriparatide - PTH analog (anabolic)
Which drug cause hypercalcemia, hyperuricemia (uric acid in urine)?
PTH analogs
