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58 Cards in this Set
- Front
- Back
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What is the goal for general population from birth up to age 30?
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Achieve the highest peak bone mass possible
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What is the goal for general population from age 30 and older?
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Maintain BMD (bone mineral density) and minimize bone loss
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What is the goal for patients with low bone mass
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Prevent progression to osteoporosis
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What is the goal for patients with osteoporosis and high-risk for osteoporosis-related fractures?
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Increase BMD, prevent further bone loss, and prevent falls and fractures
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What is the goal for patients with osteoporosis-related fractures
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adequate pain control, maximize rehabilitation to restore independence and quality of life, and prevent subsequent fracture and death
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What drugs/supplements are considered antiresorptive therapies?
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Antiresorptive therapies include calcium, vitamin D, bisphosphonates, estrogen agonists antagonists, calcitonin, denosumab, estrogen and testosterone.
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What is the efficacy of Ca and Vit D tx?
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i. Calcium with vitamin D has been demonstrated to increase BMD and reduce fractures.
ii. Osteoporosis benefits shown in clinical trials studying other drug therapies all required concurrent calcium and vitamin D. iii. Optimal calcium absorption is achieved when it is taken with adequate vitamin D and in doses of < 600 mg calcium per dose. iv. Vitamin D3 (cholecalciferol) is the usual form of vitamin D supplementation and is available in OTC products. |
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What are adverse effects of Ca and Vit D Tx?
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: constipation, bloating, and rarely hypercalcemia. Constipation is common and can be managed by increased water intake, dietary fiber, and exercise
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What are the brand names for calcium carb?
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-os cal
-tums |
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What are the select brand names for calcium citrate?
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-citracal
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What is the OTC vitamin D formulation?
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-Combination calcium and vitamin D supplements---Os-Cal D®
-Vitamin D supplement tablets: 400, 800, or 1000 IU |
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What do bisphosphonates do?
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These drugs inhibit bone resorption by inhibiting osteoclast activity. The bisphosphonates become incorporated into bone. They have long half-lives of up to 10 years.
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What bisphosphonates are indicated for are indicated for postmenopausal, male, and glucocorticoid-induced osteoporosis. Ibandronate (Boniva) is only indicated for postmenopausal osteoporosis.
C. Efficacy: |
Alendronate (Fosamax), risedronate (Actonel) and zoledronic acid (Reclast)
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What is the brand name for Alendronate?
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Fosamax
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What is the brand name for Risedronate?
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ACtonel
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What is the brand name for zoledronic acid?
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Reclast
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what is the efficacy of bisphosphonates?
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a. Improves BMD and reduces risk of fractures by 40-70% at all skeletal sites (including vertebrae and hip)
b. Oral weekly & monthly and IV regimens have shown similar efficacy to oral daily dosing and provide easier to comply with regimens. |
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What are contraindications for bisphosphonates?
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Creatinine clearance <30-35 mL/min
b. serious GI effects: esophageal disorders that delay emptying c. pregnancy |
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What are adverse effects of bisphosphonates?
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-GI effects: perforation, ulceration, GI bleeding –less with weekly and monthly compared to daily
Musculoskeletal pain – may require short term or permanent discontinuation d. Osteonecrosis of the jaw (black box warning) and subtrochanteric femoral fractures (atypical). A rare adverse effect. |
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What are administration recommendations for bisphosphonates?
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All products should be taken with full 6 to 8 oz. glass of plain water and patient should not lie down at least 30 minutes after taking alendronate or risedronate (at least 60 minutes for ibandronate) to minimize esophageal irritation.
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When is IV bisphosphonate preferred?
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IV may be preferred over oral in patients unable to stay upright for 30 to 60 minutes, those with significant GI disorders, or those with significant adherence issues
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What is the brand name for alendronate?
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fosamax
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What is the brand name and prevention dose for risedronate?
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-actonel
- -5 mg PO daily -or 35 mg PO weekly |
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What is the tx dose with risedronate?
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- 5 mg PO daily
-35 mg PO weekly - 150 mg PO monthly |
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What is the brand name for ibandronate?
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Boniva
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What is the brand name and prevention dose for Zoledronic acid?
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-Reclast
-5 mg Iv every 2 years |
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What is the tx dose for zoledronic (recast)?
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5 mg IV once a year
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What is the indication for teriparatide?
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Treatment of osteoporosis in postmenopausal women, men, and patients on glucocorticoids who are at high-risk for fractures (FDA-approved indication).
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What is the brand name for terparatide?
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forteo
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Who are examples of high risk patients that should be treated with teriparatide?
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Examples of patients at high-risk for fractures include those: with a history of fragility fracture, with multiple risk factors for fracture, who have very low bone density (T score less than -3.5). May also consider in those who have failed or are intolerant of other osteoporosis therapies
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What is the efficacy of teriparatide?
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decreases risk of vertebral and nonvertebral fractures in postmenopausal women. Significantly improves BMD in women and men
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What are the adverse effects of teriparatide?
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-Common: nausea, dizziness, leg cramps, transient orthostatic hypotension
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What are potential serious side effects and considered black box warnings for teriparatide?
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1. Teriparatide should not be used in patients at risk of osteosarcoma due to data in rats that showed an increase in osteosarcoma which was both a dose and duration effect.
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What are risk factors for osteosarcoma?
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Paget’s disease, unexplained elevations in alkaline phosphatase, and prior radiation therapy involving skeleton
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What is the dosing and administration for teriparatide?
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Comes as a prefill pen that must be kept refrigerated. Given subcutaneously 20 mcg daily into thigh or abdomen.
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When is teriparatide not recommended for?
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iii. Not recommended for > 2 yrs due to lack of long-term safety & efficacy data. Short-term teriparatide therapy (2 years) is usually followed by antiresporptive therapy.
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What is the estrogen agonist antagonist generic and bran name?
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-Raloxifene (Evista®)
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What is the place in therapy for teriparatide?
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iv. Reserve for treatment of osteoporosis in male and female patients who are high-risk for fractures OR those who have failed other therapies due to costs and adverse effects.
v. Not recommended for prevention of osteoporosis due to potential adverse effects |
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What is the efficacy of raloxifene?
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1. Reduction in vertebral fractures by 30% (agonist on bones). Inconsistent effects on hip BMD and fractures.
2. Increases BMD, but less than bisphosphonates, denosumab, and teriparatide. 3..Does not stimulate the endometrium (antagonist on uterus). Therefore, does not cause endometrial cancer 4. Lowers total and LDL cholesterol. Although, does not reduce risk of cardiovascular events. 5. Studies have demonstrated a 56-71% reduction in invasive breast cancer (antagonist on breasts). FDA-approved indication for reduction in breast cancer in patients at high risk. |
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What are contraindications for raloxifene?
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history of venous thromboembolism and stroke
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What is the dosing for raloxifene?
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60 mg PO
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What is the place in therapy for raloxifene?
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1. Therapy option for prevention of osteoporosis in postmenopausal women. Additional benefits might influence its selection.
2. Third or 4th line option for treatment of osteoporosis in postmenopausal women due to lesser benefit of fracture risk reduction than other therapies. 3. Not for use in men or glucocorticoid-induced osteoporosis. |
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What are the therapeutic uses for calcitonin salmon?
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a. Treatment of postmenopausal osteoporosis in women at least 5 years post- menopausal (FDA-approved use)
b. Prevention of postmenopausal osteoporosis (not FDA-approved use) c. Osteoporosis in men (not FDA-approved, but has been used clinically in this population based on limited clinical evidence) |
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What is the efficacy of calcitonin salmon?
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Increased BMD and reduction in new vertebral fractures by 33%. Inconsistent effects on hip BMD and fractures.
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What is the dosing for calcitonin salmon?
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200 units (one spray) IN daily in alternating nostrils
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What is the brand name for calcitonin salmon?
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Miacalcin
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What is the place in therapy for calcitonin salmon?
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a. 4th or 5th line option for treatment of osteoporosis due to lesser benefit of fracture risk reduction than other therapies.
b. Therapy option for prevention of postmenopausal osteoporosis, although lack FDA-approval for this indications. |
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What are the therapuetic uses for hormone therapy in osteoporosis?
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Prevention of postmenopausal osteoporosis (FDA-approved indication). The FDA revoked the indication for treatment of postmenopausal osteoporosis.
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what is the efficacy of hormone therapy?
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a. Reduction in fractures by 33-40%.
b. BMD benefits less than bisphosphonatesbut similar efficacy to calcitonin and raloxifene. c. Minimal efficacy observed with estrogen vaginal rings and creams. |
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what is the dosing for hormone therapy?
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Various formulations and regimens (including oral, transdermal, continuous dosing, or cyclic dosing) are equally effective in increasing BMD. BMD effects are dose-dependent, with efficacy at doses as low as 0.3 mg conjugated equine estrogen. Due to the risks, should use the lowest dose possible.
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What is the place in therapy for hormone therapy?
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a. Long-term HT is no longer recommended due to risks with long-term use.
b. Should only be use short-term in women who need HT for menopausal symptoms (i.e. hot flashes) and not solely for osteoporosis prevention. c. Not recommended for use in men or glucocorticoid-induced osteoporosis |
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What is the brand name for denosumab?
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prolia
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What are the therapeutic uses for denosumab?
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i. Treatment of osteoporosis in postmenopausal women at high risk for fracture (FDA-approved indication).
ii. Treatment of osteoporosis in postmenopausal women who have failed or are intolerant to other available osteoporosis therapies (FDA-approved indication). |
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What is the efficacy for denosumab?
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i. In placebo-controlled studies, denosumab decreased vertebral fractures by 68% and hip fractures by 40%.
ii. denosumab appears to have similar efficacy to bisphosphonates and teriparatide in reduction of fractures. |
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What are adverse effects of denosumab?
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i. Common: back pain, pain in extremities, musculoskeletal pain, hyperlipidemia, cystitis
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What are severe side effects of denosumab?
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: Higher risk of serious infections leading to hospitalization. Patients should monitor for fever, cellulitis, severe abdominal pain, or urinary frequency. Additionally, denosumab possibly increases risk for jaw osteonecrosis and atypical fractures due to its action in suppression of bone turnover.
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What is the dosing and administration for denosumab?
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i. 60 mg SC every 6 months
ii. Recommended to be administered by healthcare provider. iii. Patients should be tested for hypocalcemia prior to each dose (because it may exacerbate an underlying hypocalcemia) |
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What is the place in therapy for denosumab?
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i. Recommended to reserve for treatment of osteoporosis in postmenopausal women who are at high risk for fractures OR do not tolerate or get enough benefit from other osteoporosis medications.
ii. Not currently recommended for prevention of osteoporosis or for use in men. |
