Osteoporosis

Which of the following statements is CORRECT about Reclast?

Answer: A Reclast is zoledronic acid; it only comes in 5 mg /100 mL bottle for IV infusion once a year. Prolia (denosumab) is available in 60 mg/mL, and it is given SC once every 6 months. Miacalcin (calcitonin-salmon) can be given SC or IM 100 units every other day. Forteo (teriparatide) is available only in SC, and the dose is 20 mcg once daily.

Which of the following is/are available in an intravenous formulation? Select ALL that apply.

Answer: C, D, E Alendronate and risedronate are NOT available in IV formulations. • Ibandronate (Boniva) - tabs and IV • Zoledronic acid (Reclast) - only IV • Zoledronic acid (Zometa) - only IV • Pamidronate (Aredia) - only IV

Forteo (teriparatide) injection is used to treat which of the following?

Answer: D Forteo (teriparatide) is a parathyroid hormone analog used for osteoporosis. It is administered 20 mcg SC daily in the thigh or abdomen for no longer than 2 years. It is to be taken with vitamin D and calcium.

What is the mechanism of action of denosumab? Select ALL that apply.

Denosumab is a monoclonal antibody with affinity for nuclear factor-kappa ligand (RANKL). Osteoblasts secrete RANKL; RANKL activates osteoclast precursors and subsequent osteolysis which promotes the release of bone-derived growth factors. B is raloxifene (Evista) (SERM) C is teriparatide (Forteo)(PTH)

T.N. just picked up her calcitonin nasal spray and asks if she should shake it before use. Which of the following is the CORRECT response?

Do NOT shake calcitonin nasal spray.

What is the generic of Boniva?

Ibandronate

What are the brand names of denosumab? Select ALL that apply.

Prolia and Xgeba

Teriparatide is stored in the refrigerator in the pharmacy. How long can it be out of the refrigerator?

Teriparatide (Forteo) is stored in the refrigerator at all times.

Calcitonin nasal spray is refrigerated in the pharmacy. How long can it be stored at room temperature?

35 days

F.E., a 65-year-old female, comes to the pharmacy to pick up her Synthroid. She has heard that her friends are getting screened for osteoporosis and wonders when she should have a DEXA scan. She states that she does not drink alcohol or smoke and she exercises 5 times a week. She has never broken a bone, and she rates her overall health as excellent. What is your recommendation for F.E.?

Answer: A National Osteoporosis Foundation (NOF) recommendation for bone density test: Women > 65 years old Men > 70 years old Break a bone after age 50 Postmenopausal women under age 65 with risk factors Men age 50-69 with risk factors

All the following unopened medications have to be stored in the refrigerator EXCEPT:

Answer: B Unopened Reclast is stored at room temperature; once opened, Reclast is stable in the refrigerator for 24 hours. Unopened Forteo (teriparatide), Fortical (calcitonin), Miacalcin (calcitonin) and Prolia (denosumab) have to be refrigerated.

Which of the following is the CORRECT counseling for a patient using calcitonin nasal spray?

Fortical, Miacalcin: Intranasal: 200 units (1 spray) in one nostril once daily.

Which of the following is/are TRUE about Prolia? Select ALL that apply.

Refrigerated, 60mg SQ q6 months contraindicated in hypocalcemia, osteonecrosis, and atypical femur fractures have been reported

What allergy is of concern with calcitonin?

Salmon

Which one of the following statements is NOT TRUE about Miacalcin?

Answer B All of the above are correct regarding calcitonin nasal spray (Miacalcin) except that it is used once a day, alternating nostrils every day (not each nostril). The bottle must be primed before first use. The patient should hold the bottle upright and press on the side arms until a spray is produced - it is activated now. Other than osteoporosis, calcitonin (Miacalcin, Fortical, Calcimar) can be used for Paget's disease and acute treatment of hypercalcemia. Calcitonin comes in injectable (IM or SC) form or intranasal. If used via SC or IM route, do a skin test before using injectable product. Store bottle in use at room temperature between 15°C-30°C (59°F-86°F) in an upright position, for up to 35 days. Each bottle contains at least 30 doses.

J.M., a 76-year-old female patient was recently diagnosed with osteoporosis. Medical History: HTN Medication: hydrochlorothiazide, lisinopril (Zestril) Social History: Smoker/drinks a glass of wine 4-5x a week Family History: Mother has osteoporosis & had a hip fracture at age 75 Vitals: BP: 149/87 mmHg P: 74 RR: 14 Temp: 98.6 Labs: Hb A1c: 6.7% DEXA results: T-score: - 2.8 at the hip. What class of osteoporosis medications is considered the first line for J.M.?

Answer: A For most postmenopausal women with osteoporosis, oral bisphosphonates are considered first-line therapy. Intravenous (IV) bisphosphonates such as zoledronic acid, which has been demonstrated to reduce vertebral and hip fractures, is a good alternative for individuals with gastrointestinal intolerance to oral bisphosphonates.

Actonel-induced jaw osteonecrosis can be prevented by using .........................

Answer: A Periogard and Peridex (chlorhexidine 0.12%) mouthwashes are used to prevent jaw osteonecrosis that is caused by bisphosphonates like Actonel (risedronate). Actidose Aqua is an activated charcoal that is used for poisoning rescue. Periostat is 20 mg doxycycline which is used for periodontitis. Silvadene is silver sulfadiazine cream used to treat burns. PreviDent is sodium fluoride dental gel that is used for dental caries prophylaxis

R.B., a 68-year-old female comes to the clinic for her yearly checkup. At the visit, she says that she looked on the internet and saw that she could take Boniva once Q 3 months. With regards to Boniva, select ALL the correct responses that apply.

Answer: A, B, C, D Boniva (ibandronate) is a bisphosphonate. 150 mg PO Q month or IV 3 mg Q 3 months Used for both treatment and prevention. Osteonecrosis of the jaw has been reported

A 65-year-old woman comes to the clinic for her yearly checkup. Medications: Conjugated equine estrogen 0.625 mg and medroxyprogesterone 2.5 mg daily Binosto 70 mg Q week Calcium carbonate 600 mg with vitamin D 400 IU, one tablet twice daily Habits: Nonsmoker, Weight-bearing exercise 3-5 days per week DEXA results: T-score at the hip: - 0.8 How should she be taking Binosto? Select ALL that apply.

Answer: A, C Alendronate - Tablet, effervescent (Binosto) Prophylaxis: 5 mg QD or 35 mg once weekly Treatment: 10 mg QD or 70 mg once weekly Administer first thing in the morning and ≥30 minutes before the first food, beverage (except plain water), or other medication(s) of the day. Do not take with mineral water or with other beverages. Patients should be instructed to stay upright (not to lie down) for at least 30 minutes and until after first food of the day (to reduce esophageal irritation).

What are some concerns related to adverse effects of Forteo? Select ALL that apply.

Answer: A, C Forteo may cause orthostatic hypotension; use with caution in patients at risk of this effect or in those who would not tolerate transient hypotensive episodes. (cerebrovascular disease, cardiovascular disease, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia). Transient orthostatic hypotension usually occurs within 4 hours of dosing and within the first several doses. Transient hypercalcemia noted, NOT hypocalcemia.

R.R. is a 63-year-old patient with osteoporosis. Her physician wrote her a prescription for zoledronic acid 4 mg IV once every 3-4 weeks for osteoporosis. Your technician, J.J., gives you a vial of Zometa. Which of the following is/are the appropriate action(s)? Select ALL that apply.

Answer: A, C Reclast: 5 mg/100 mL Zometa: 4 mg/100 mL Reclast: Osteoporosis treatment: Males or postmenopausal females: IV 5 mg once a year Osteoporosis - glucocorticoid-induced - treatment and prevention: Females or males: IV 5 mg once a year Osteoporosis prevention: Postmenopausal females: IV 5 mg once every 2 years Zometa: Hypercalcemia of malignancy (albumin-corrected serum calcium ≥12 mg/dL): IV 4 mg (maximum) given as a single dose. Wait at least 7 days before considering re-treatment. Multiple myeloma osteolytic lesions: IV 4 mg once every 3 to 4 weeks Bone metastases from solid tumors: IV 4 mg once every 3 to 4 weeks

Which of the following are concerns related to the side effects of Boniva? Select ALL that apply.

Answer: A, C, E Boniva (ibandronate) does not cause an increase in uric acid or pancreatitis. Bisphosphonates side effects: Hypocalcemia: Hypocalcemia has been reported with the use of bisphosphonates. Prior to therapy initiation, hypocalcemia must be corrected; ensure adequate calcium & vitamin D intake. Osteonecrosis of the jaw (ONJ) GI mucosal irritation: May cause irritation to upper gastrointestinal mucosa. Esophagitis, dysphagia, esophageal ulcers, esophageal erosions, and esophageal stricture (rare) have been reported with oral bisphosphonates.

For a female patient, what is/are the risks associated with being on conjugated equine estrogen and medroxyprogesterone acetate?

Answer: A, C, E Estrogen is FDA approved for the prevention of osteoporosis. It does NOT cause osteoporosis. Estrogen increases the risk of: - Breast cancer - Clots: MI, stroke, PE, and DVT - Hypercalcemia - Gallbladder disease - Elevate BP, triglycerides, and fluid retention

What is the dose of teriparatide, how is it administered and where is it stored?

Answer: B Forteo (teriparatide) is given 20 mcg SC daily, and it is stored in the refrigerator.

All of the following medications can cause osteoporosis EXCEPT:

Answer: B Medications that can cause osteoporosis include corticosteroids such as Medrol (methylprednisolone), anti-epileptic drugs such as Dilantin (phenytoin), aromatase inhibitors such as Femara (letrozole) and GnRH analogs such as Eligard (leuprolide), Lupron (leuprolide), Zoladex (goserelin), and Trelstar (triptorelin). Aredia (pamidronate) is a bisphosphonate drug.

J.M., a 76-year-old female patient, was recently diagnosed with osteoporosis. Medical History: HTN Medication: hydrochlorothiazide, lisinopril (Zestril) Social History: Smoker/drinks a glass of wine 4-5x a week Family History: Mother has osteoporosis & had a hip fracture at age 75 Vitals: BP: 149/87 mmHg P: 74 RR: 14 Temp: 98.6 Labs: Hb A1c: 6.7% DEXA results: T-score: - 2.8 at the hip Can her hydrochlorothiazide contribute to her osteoporosis?

Answer: B Thiazide diuretics might actually improve bone mineral content in both men and women by stimulating the distal tubular reabsorption of calcium to decrease urinary calcium excretion and positively affecting bone mineral density.

True or False: Fortical nasal spray is stored on the pharmacy shelves.

Answer: B False, stored in fridge Fortical is calcitonin used for osteoporosis, Paget's disease, osteogenesis imperfecta, and hypercalcemia. It is administered SC, IM, or intranasal. A skin test (intradermal) is generally done before using an injectable product (risk of anaphylaxis). For osteoporosis, it is given 100 units SC/IM every other day or 200 units (1 spray) intranasal daily.

J.M., a 66-year-old female patient, was recently diagnosed with osteoporosis. Medical History: class III heart failure Medications: Lisinopril (Zestril) Metoprolol (Toprol XL) Furosemide (Lasix) Eplerenone (Inspra) Digoxin (Lanoxin) Atorvastatin (Lipitor) Hydralazine (Apresoline) Nitroglycerin Social History: Non-Smoker/drinks a glass of wine 4-5x a week Family History: Father had a heart attack when he was 55 Vitals: BP: 155/87 mmHg Pulse: 74 RR: 14 Temp: 98.6 Labs: CrCl < 28 mL/minute Which of the following would you NOT recommend for this patient? Select ALL that apply.

Answer: B, C Bisphosphonates are typically contraindicated or not recommended with eGFR less than 35 mL/min. Raloxifene (Evista) and calcitonin are less potent than bisphosphonates and are used less frequently for the treatment of osteoporosis in postmenopausal women. However, raloxifene with calcitonin is a reasonable alternative to bisphosphonates considering the patients' CrCl.

Which of the following is/are FDA approved for the treatment of hypercalcemia of malignancy? Select ALL that apply.

Answer: B, C Hypercalcemia is relatively common in patients with cancer. It occurs in patients with both solid tumors and hematologic malignancies. The most common cancers associated with hypercalcemia are breast and lung cancer and multiple myeloma. Among the currently available agents for the treatment of malignancy-associated hypercalcemia, intravenous (IV) zoledronic acid (ZA) (Zometa) or pamidronate are the bisphosphonates of choice. ZA is favored by some because it is more potent than pamidronate and can be administered over a shorter time period (15 minutes compared to two hours). Reclast 5 mg is not indicated for hypercalcemia of malignancy; while Zometa 4 mg is indicated for hypercalcemia of malignancy (refer to your notes). We use IV bisphosphonates to treat hypercalcemia of malignancy. Actonel and Fosamax are both ORAL only.

What formulations is/are Miacalcin available in? Select ALL that apply.

Answer: B, C, D Miacalcin is available in IM, SubQ and intranasal.

R.J., a 67-year-old woman comes to the clinic concerned about osteoporosis. Medications: Calcium carbonate 600 mg with vitamin D 400 IU, one tablet twice daily Metformin 850 BID Pioglitazone 45 mg once daily Pantoprazole 40 mg once daily Family History: Her mother has osteoporosis and had a hip fracture at age 68 Habits: Smoker DEXA results: T score of the lumbar spine: - 2.4 T score of her hip: - 2.0 She asks about her risk factors for osteoporosis. Select ALL that apply.

Answer: B, C, D, E Increased incidence of bone fractures in females treated with pioglitazone. Increased incidence of osteoporosis-related bone fractures with PPI therapy. Patients on high- dose or long-term therapy (≥1 year) should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce the risk of fractures in patients at risk. Other risk factors include a history of previous fracture, advanced age, long-term glucocorticoid therapy, low body weight (less than 58 kg [127 lb]), family history of hip fracture, cigarette smoking, and excess alcohol intake.

What are the brand names of risedronate? Select ALL that apply.

Answer: B, E Risedronate (Actonel) (Atelvia) Alendronate (Fosamax) (Binosto)

Which one of the following is an FDA approved indication for the use of Hyalgan?

Answer: C Hyaluronate (Hyalgan, NeoVisc, OrthoVisc) and Hylan GF-20 (Synvisc) are all gel-like, elastic material injected into the knee joints of patients with osteoarthritis to improve viscosity and elasticity of the affected joint(s). The effect lasts about 3 months. Caution in allergy to eggs, avian proteins or feathers. Hyaluronic acid is Restylane - a cosmetic injection for moderate-severe facial wrinkles.

All the following medications are available in injectable form EXCEPT:

Answer: C Teriparatide (Forteo) is available as SC form. Pamidronate (Aredia) is IV. Risedronate is tablet form only. Zoledronic acid (Reclast, Zometa) is IV infusion. Ibandronate (Boniva) comes in tablets and IV forms.

Forteo should be avoided in all the following cases EXCEPT:

Answer: D Forteo (teriparatide) is an injectable 20 mcg SC QD recombinant parathyroid hormone that is used to treat osteoporosis for patients with high risk of fractures for no longer than 2 years. Forteo's black box warning is osteosarcoma; thus, it should be avoided in patients with Paget's diseases, open epiphysis, skeletal malignancy history and with pediatric patients. Urolithiasis is not a contraindication but should be watched for. Forteo can increase the levels of uric acid causing kidney stones along with a transient increase in calcium (4-6 hours post-dose).

Mrs. J.H. comes to your pharmacy with a new prescription for Boniva 150 mg PO once a month. Which of the following is the CORRECT patient counseling?

Answer: D Boniva (ibandronate) should be taken on an empty stomach with 8 oz of water. Avoid lying down for 60 minutes to avoid GI side effects. Calcium and vitamin D supplements are recommended if inadequate dietary intake; however, advise patients not to take them at the same time as Boniva as they may reduce its absorption. Boniva may cause hypocalcemia.

A.K., a 62-year-old Caucasian woman, had a hysterectomy one week ago due to uterine prolapse. She comes into the pharmacy to refill her medications. Medications: Conjugated equine estrogen 0.625 mg and medroxyprogesterone acetate 2.5 mg daily Calcium carbonate 600 mg with vitamin D 400 IU one tablet twice daily Habits: Nonsmoker. Weight-bearing exercise 1-2 days per week DEXA results: T-score at the hip: - 1.8 Which of the following would you recommend?

Answer: D Endometrial hyperplasia and cancer can occur after as little as six months of unopposed estrogen therapy; as a result, a progestin should be added in women who have not had a hysterectomy. Women who have undergone hysterectomy do not need and should not receive a progestin.

What is the dose of Forteo?

Answer: D Forteo(teriparitide), when used for osteoporosis, is dosed 20 mcg SubQ once daily. Initial administration should occur under circumstances in which the patient may sit or lie down, in the event of orthostasis.

How long can Miacalcin be out of the refrigerator?

Answer: D Miacalcin can be out of the fridge for 35 days; Fortical for 30 days. Make sure patients keep the bottle in an upright position.

U.J., a 63-year-old woman, comes to the clinic concerned about osteoporosis. She had a DVT three months ago and has a history of severe GERD. Medications: Calcium carbonate 600 mg with vitamin D 400 IU, one tablet twice daily Coumadin 4 mg QD Pantoprazole 40 mg once daily Habits: Smoker. Weight-bearing exercises 1-3 days per week Weight: 142 lbs DEXA results: T score of the lumbar spine: - 2.4 T score of the hip: - 2.0 Base on past medical history, which of the following osteoporosis medications would be considered the safest and the most appropriate for treatment of her osteoporosis?

Answer: D She is not a candidate for Evista due to having a DVT three months prior; Evista is a Selective Estrogen Receptor Modulator (SERM) and can cause DVT. Also, not a candidate for Premphase for the same reason; Premphase (medroxyprogesterone + estrogen) - estrogen can cause clots. Also, estrogen is for prevention of osteoporosis, NOT treatment. She is not a candidate for alendronate (Binosto) or risedronate (Atelvia) due to her severe GERD.

A 65-year-old woman comes to the clinic for her yearly checkup. Medications: Conjugated equine estrogen 0.625 mg and medroxyprogesterone 2.5 mg daily Binosto 70 mg Q week Calcium carbonate 600 mg with vitamin D 400 IU one tablet twice daily Habits: Nonsmoker, Weight-bearing exercise 3-5 days per week DEXA results: T-score at the hip: - 0.8 Are her current medications controlling her osteoporosis?

Answer: D The T-score is a measure of bone density compared to what is normal. -1 and above means bone density is normal. Between -1 and -2.5 means osteopenia (low bone density, pre-osteoporosis). -2.5 and below: likely osteoporosis.

What is the dose of alendronate to treat glucocorticoid-induced osteoporosis in male or premenopausal women?

Answer: E Alendronate (Fosamax) dosages are as follows: 10 mg PO QD or 70 mg PO QWK to treat osteoporosis in post-menopausal or male patients. 5 mg PO QD or 35 mg PO QWK to prevent osteoporosis in post-menopausal or male patients. 5 mg PO QD to treat glucocorticoid-induced osteoporosis; increase to 10 mg PO QD if the patient is post-menopausal and not taking estrogen.

A physician calls you regarding the dose and duration of zoledronic acid for treating osteoporosis. Which of the following is the CORRECT response?

Answer: E Osteoporosis treatment (Reclast): IV - 5 mg once a year

Which of the following is/are the indication(s) for using pamidronate (Aredia)? Select ALL that apply.

Indicated for Paget, Multiple myeloma, and hypercalcemia of malignancy