MB is a postmenopausal 55yoF (43kg, 59”) who has just followed up with her primary care provider for routine labs and osteoporosis screening. PMH significant for DVT, unresolved urinary stones, and depression. 

Current Medications

Paxil 40 mg QD

Vitamin D3 2000 IU QD

Calcium 1200 mg QD

Tylenol 500 mg TID PRN

Labs/Vitals

BP: 119/80 mmHg

HR: 72 bpm

RR: 20 

Temp: 97.5 F

K: 4.2 mEq/L

Ca: 10 mg/dL

Dual-energy x-ray Absorptiometry (DXA) Findings:

Lumbar spine T-score = -2.6

Femoral neck T-score = -1.9

Following a diagnosis of osteoporosis, which of the following would be the most acceptable treatment options for MB? Select all that apply. 

A. Denosumab

B. Duavee

C. Fosamax

D. Evista

E. Forteo

Answer with rationale

Osteoporosis is the most common bone disease that is characterized by deterioration of bone tissue, loss of bone mass, and an increase in the risk of fractures. The loss of balance in the activity of osteoclasts and osteoblasts during bone remodeling plays an important role in osteoporosis. Osteoclasts are responsible for bone resorption, while osteoblasts are responsible for bone formation. These two processes are what maintain the renewal of old and damaged bones. Therefore, when we see excessive bone resorption and inadequate bone formation, the bone becomes fragile and more susceptible to fractures. Osteoporosis can occur in both men and women, but it is more prevalent among postmenopausal women. It can occur as a result of age-related bone loss, and this natural bone loss becomes accelerated in the years following menopause. Other risk factors for osteoporosis include low body weight, smoking, vitamin D and calcium insufficiency, as well as long-term use of proton pump inhibitors, glucocorticoids, and SSRIs.

Many patients are unaware they have osteoporosis, as it is often asymptomatic. Therefore, it is important to conduct bone mineral density testing in all women 65 years of age and older, all men 70 years of age and older, and all patients with risk factors for osteoporosis. Osteoporosis is preventable and treatable with many options available. Regardless of drug selection, all patients must receive adequate levels (recommended daily allowances) of vitamin D and calcium either through diet or supplementation.

Answer A is correct. Denosumab is a monoclonal antibody that binds to RANKL to prevent osteoclast formation. It is available as a 60 mg subcutaneous injection that is administered every 6 months. This would be an appropriate treatment option for MB, as it is only contraindicated in pregnant patients and patients with hypocalcemia. Some considerations for denosumab is that its effects decline following discontinuation of therapy, allowing for rapid bone loss to occur. 

Answer B is incorrect. Bazedoxifene is a selective estrogen receptor modulator (SERM) that works with conjugated estrogens (brand name of combination is Duavee) to maintain bone mineral density in postmenopausal females. It is not an appropriate treatment option in this patient, as it is contraindicated in patients with a history of VTE. Furthermore, it is only used for the prevention of osteoporosis following menopause – not for treatment. 

Answer C is correct. Fosamax is a bisphosphonate that inhibits bone resorption and osteoclast activity, thereby increasing bone density. It is a first line option for men and for postmenopausal women who are at high risk of fractures. It can be taken orally daily or weekly. The benefit of reducing fracture risk may continue for 5 years following discontinuation of therapy. It is important to counsel on proper administration to avoid negative esophageal effects and aspiration. Counsel the patient to stay upright for 30 minutes and to drink 6 to 8 oz of water on an empty stomach following administration. 

Answer D is incorrect. Evista is a selective estrogen receptor modulator (SERM) that decreases bone resorption. This would not be an acceptable treatment option in this patient, as it is contraindicated in patients with a history of VTE. It has a boxed warning for increased risk of VTE and increased risk of death due to stroke in women with CHD or who are at risk for coronary events. Furthermore, Evista is not a first line treatment option for osteoporosis. 

Answer E is incorrect. Forteo is an analog of human parathyroid hormone. It is a daily subcutaneous injection that stimulates osteoblast activity and increases bone formation. Forteo is not an appropriate treatment option for this patient. MB has active urinary stones, and Forteo has the potential to cause an exacerbation in patients with recent or active urolithiasis and has not been evaluated in patients with active kidney stones. Furthermore, Forteo is only indicated in patients who are very high risk for fractures - patients who have had a previous fracture within the past 12 months, who are at a high fall risk, who have endured multiple fractures, and who have a T score < -3.0. In addition it could be used in patients with no contraindications to Forteo who have demonstrated intolerance to other first-line medications or have failed these therapies.

Brand/Generic: acetaminophen (Tylenol); alendronate (Fosamax); bazedoxifene/conjugated estrogens (Duavee); denosumab (Prolia); paroxetine (Paxil); raloxifene (Evista); teriparatide (Forteo)

Of note, denosumab also has a branded name of Xgeva but this is indicated for diseases outside of osteoporosis such as prevention of musculoskeletal events in patients with multiple myeloma. 

NAPLEX Content Domains Covered:

1.A.1 - Pharmacology

2.A.1 - Drug names and therapeutic classes

2.A.2 - Indications, usage, and dosing regimens

2.A.4 - Prescription regulations (eg, boxed warnings, risk evaluation and mitigation strategies)

3.C.2 - Appropriateness of therapy (eg, medications, immunizations, non-drug therapy, dosing, contraindications, warnings, evidence-based decision making)