Osteoporosis Pre-class

Recommend appropriate calcium and vitamin D supplementation: How much elemental calcium in calcium carbonate?

Recommend appropriate calcium and vitamin D supplementation: How much elemental calcium in calcium carbonate?

40%

Recommend appropriate calcium and vitamin D supplementation: How much elemental calcium in calcium citrate?

21%

Recommend appropriate calcium and vitamin D supplementation: Based on NOF recommendations, how much calcium is recommended for women ≥ 51 years old?

1200 mg/d

Recommend appropriate calcium and vitamin D supplementation: Based on NOF recommendations, how much calcium is recommended for men 50 - 70 years old?

1000 mg/d

Recommend appropriate calcium and vitamin D supplementation: Based on NOF recommendations, how much calcium is recommended for men ≥ 71 years old?

1200 mg/d

Recommend appropriate calcium and vitamin D supplementation: Based on the National Osteoporosis Foundation, how much vitamin D is recommended for adults age ≥ 50 years?

800 - 1000 IU (1000 IU = 25 mcg)

Recommend appropriate calcium and vitamin D supplementation: Based on the American Geriatric Society, what is the minimum vitamin D supplementation (w/ Ca) for adults to reduce the risk of fractures and falls

at least 1,000 IU (w/ Ca)

Recommend appropriate calcium and vitamin D supplementation: Based on the Endocrine Society, what is the amount of vitamin D supplementation for adults ≥ 65 years for the prevention of falls and fractures?

800 IU/d

Recommend appropriate calcium and vitamin D supplementation: What is the goal 25(OH) vitamin D level?

30-50 ng/mL or ≥ 30 ng/mL

Recommend appropriate calcium and vitamin D supplementation: What is the range of 25(OH) vitamin D is treatment indicated?

25(OH)-vitamin D <20 ng/mL

Recommend appropriate calcium and vitamin D supplementation: What is the frequency of administering 50,000 IU vitamin D (D2 or D3) for repletion?

once a week

Recommend appropriate calcium and vitamin D supplementation: What is the maintenance amount of Vitamin D supplementation?

1500-2000 IU daily

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Which medications are used for treatment?

1. bisphosphonates

2. raloxifene

3. calcitonin

4. PTH analog

5. denosumab

6. romosozumab

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Which medications are used for prevention?

1. bisphosphonates

2. raloxifene

3. estrogen

4. estrogen/bazedoxifene

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Which medications are used for BOTH treatment prevention?

1. bisphosphonates

2. raloxifene

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Which medications can be used in men?

1. bisphosphonates

2. PTH analogs (teriparatide)

3. denosumab

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When taking Bisphosphonates, what should be told to the patient (aka when they are about to take the medication)?

Take in the morning, on an empty stomach with 6-8 oz of plain water

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After a patient has taken their dose of bisphosphonate, the patient should follow what instructions?

No food/beverage for ≥ 30 minutes, Remain sitting/standing for ≥ 30 minutes

Why should patients follow the strict counseling for bisphosphonate?

to improve bioavailability and reduce risk of esophageal ulceration

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What are the adverse effects with bisphosphonate?

1. Decreased serum Ca+

2. GI effects (Abdominal pain, Nausea / dyspepsia)

3. Esophageal inflammation (esophagitis)

4. Muscle and skeletal pain

5. Osteonecrosis of the jaw (ONJ)

6. Atypical femur fractures

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What is the RARE adverse effect with bisphosphonate?

Osteonecrosis of the jaw (ONJ) (associated with long term use and high-doses used for hypercalcemia in malignancy)

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What is the BASELINE monitoring for bisphosphonate?

1. BMD (bone mineral density)

2. Serum Ca+ and 25(OH)-D

3. Renal function (IMPORTANT)

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What is the monitoring for bisphosphonate DURING treatment?

1. BMD 1-3 years after initiating treatment then as needed

2. Serum Ca+ and 25(OH)-D

3. Renal function (IMPORTANT)

4. Adverse effects (thigh/groin pain; GI effects)

5. Medication adherence and appropriate administration (duh)

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Why is checking renal function both a baseline and continuous monitoring parameter for bisphosphonates?

Not recommended for use below certain CrCl thresholds:

• CrCl < 30 → d/c use of risedronate, ibandronate

• CrCl < 35 → d/c use of alendronate, zoledronic acid

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When should denosumab (Prolia) be used?

• postmenopausal W + M

• Glucocorticoid-induced osteoporosis

• tx bone loss in W/M receiving meds for breast/prostate cancer

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How is Prolia administered?

q 6 months SQ (HCP needed, only ARM, THIGH, ABDOMEN)

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What are denosumab’s adverse effects?

1. HYPOcalcemia

   1. MUST correct b4 tx

2. skin infections (cellulitis) + skin rash

3. musculoskeletal pain

4. flatulence, constipation

5. ONJ (more common when tx-ing malignant cancer)

6. Atypical femur fractures

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What is an important lab to take when monitoring a pt’s initiation with Prolia?

Serum Ca2+ (BASELINE + w/in first 14 days of tx)

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What are important counseling points with Prolia?

• inform PCP of new hip/thigh/groin pain or skin rxns

• rapid bone loss once denosumab d/c

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When would raloxifene (Evista) be considered for use?

• Treatment and prevention of postmenopausal osteoporosis

  • decr risk for breast cancer (post-menopause)

  • req 5 year tx duration

  • NOTE: formulation = oral pill (good for pts who don’t want injections)

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What is the BBW w/ raloxifene (Evista)?

• incr risk of DVT + PE

  • do NOT use in W w/ hx of VTE

• incr risk of death from stroke in W w/ CVD or at risk

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What are the ADRs w/ raloxifene (Evista)?

1. hot flashes

2. PE

3. leg cramp/muscle spasm

4. flu-like syndrome/arthralgias

5. incr TGs in W w/ elevated TG

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What are important monitoring parameters w/ raloxifene (Evista)?

• mammogram / breast exam b4/during tx

• lipids

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When would teriparatide (Forteo) be considered?

• post-menopause osteoporosis

• MEN

• glucocorticoid induced

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When would abaloparatide (Tymlos) be considered?

post-menopause osteoporosis

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What is a potential risk with PTH analogs?

risk of osteosarcoma → limit tx use to 18-24 months

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What are ADEs with PTH analogs teriparatide and abaloparatide?

• HYPERcalcemia (4-6 hours after injection)

• orthostatic hypotension

• N/V, dyspepsia

• dizzi, headache

• arthralgias, leg cramp, weakness

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What is an important counseling point with PTH analogs?

• sit for first dose to avoid orthostatic hypotension

• rotate injection points

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Calcitonin (Miacalcin) can come in a nasal solution and IM/SQ injection, what is the amount of units delivered in both formulations?

Nasal sln: 200 units/spray

IM/SQ: 100 units/day

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What are ADE w/ calcitonin?

• allergic + hypersensitivity rxns (anaphylaxis)

• HYPOcalcemia

• nasal irritation / injection site rx

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When is romosozumab-aqqg (Evenity) considered?

postmenopausal osteoporosis

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How is romosozumab-aqqg (Evenity) administered?

q month for 12 months by HCP w/ 2 injections per visit

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What is the BBW w/ romosozumab-aqqg (Evenity)?

may increase risk of MI, stroke, CV death

• do not use in pts who have had an MI/stroke w/in preceding year

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What is an ADE with Evenity that was significant when compared with a placebo?

injection site reactions

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When is estrogen ± progestin considered? (estrogen-only = Premarin) (E + P = Combipatch)

prevention of postmenopausal osteoporosis

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For W who have not had a hysterectomy, what do they require?

progestin to protect uterine lining

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What are the BBWs w/ estrogen?

• do not use for prevention of CV dz (estrogen incr risk of clots)

• incr risk of breast cancer (E+ P)

• do not use for prevention of dementia

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What are ADEs w/ estrogen?

• Headache

• abdominal pain

• weight gain, edema

• increase TGs + HDL-C , decr LDL-C

• rapid bone loss when d/c

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What are important monitoring / counseling w/ estrogen ± progestin?

M: risk for breast cancer + CVD b4/during tx

C: W w/ uterus get BOTH E + P

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When should conjugated estrogens/bazedoxifene (Duavee) considered?

only W W/ UTERUS

• prevention of postmenopausal osteoporosis

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What are the BBWs w/ estrogens/bazedoxifene (Duavee)?

• do not use for prevention of CVD

• do not use for prevention of dementia

Special consideration: do not use in pts w/ hx of VTE

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What medications are associated with osteoporosis? (red bolded)

1. Depo-medroxyprogesterone

2. thiazolidinediones (TZD)

3. SGLT2-i

4. glucocorticoids (≥ 5 mg/d prednisone* for ≥ 3 months)

5. Thyroid hormone (in excess)

6. GnRH agonists/antagonists

Provide appropriate counseling (including administration directions and adverse effects) for osteoporosis medications