What types of medication are usually prescribed for osteoporosis

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If you are told you have osteopenia or are diagnosed with osteoporosis, calcium and Vitamin D supplementation with appropriate exercise may not be enough to decrease bone loss or build bone. You may need a prescription medication. Some medications are only prescribed for women and others are prescribed for both women and men.

The North American Menopause Society (NAMS) advises that the following women receive prescription medication as part of their treatment for osteoporosis:

Postmenopausal women who sustain a fracture of a vertebra as a result of osteoporosis.

• Postmenopausal women whose T scores are lower than -2.5.

• Postmenopausal women with T scores lower than -2.0 with at least one additional risk factor for fracture.

Antiresorptive agents

Medications and substances that decrease bone resorption (bone breakdown).

The types of prescription medication fall into two categories. The first category of medications is called antiresorptive agents. They are intended to work on the osteoclasts to inhibit bone resorption, meaning that the medications interfere with the cells that are trying to break down old bone. Estrogen therapy (ET) is one of these types of medications and for post-menopausal women has been found to be very effective in the prevention of osteoporosis. ET is appropriate for preventing osteoporosis in postmenopausal women who are experiencing significant menopausal symptoms (see Questions 64-66). Other medications that fall into the group of drugs intended to prevent further loss by slowing down the breakdown of bone include bisphosphonates, calcitonin, and selective estrogen receptor modulators (SERMs). Questions 57 to 65 contain a full discussion of each drug. Although the medications do not make new bone directly, they do assist in increasing bone density by slowing down the rate at which old bone is broken down.

There currently is only one FDA-approved medication in the second category of medications used to treat osteoporosis. This medication is called an anabolic agent, which works with osteoblasts to actually build bone (see Question 62).

The most important thing for you to remember is that prescription medications do not usually contain calcium or Vitamin D; however, Fosamax (alendronate) Plus D and Actonel® (risedronate) with Calcium were recently approved. Fosamax Plus D contains 2,800 IU of Vitamin D, a week's worth of Vitamin D. Actonel with Calcium is a new way of packaging the once-weekly Actonel dose. The package includes four weeks of medication. Each week has one 35-mg Actonel tablet and six 1,250-mg calcium carbonate tablets (500 mg elemental calcium each) to take on the days that Actonel is not taken. Even if you take the prescription medication faithfully, you will not

Bisphosphonates

A group of antiresorp-tive agents, such as Fosamax, Boniva, and Actonel, which slow the rate at which bone is broken down.

SERMs (selective estrogen receptor modulators)

Antiresorptive medications such as Evista that help to reduce bone loss by their positive estrogenic effects.

Anabolic agent

Medication, steroid hormone, or substance intended to build bone; examples are Forteo (teriperatide) and testosterone.

Bisphosphonates must be taken alone, on an empty stomach, w ith a plain glass of water first thing in the morning or when you are up for the rest of the day.

get the full benefit of its effects without getting adequate calcium and Vitamin D in your diet or by supplements. So, make sure that your prescription medication has a chance to work by remembering to take the necessary amount of calcium and Vitamin D. If you are prescribed a bisphosphonate, you must NOT take calcium and the medication at the same time. Bisphosphonates must be taken alone, on an empty stomach, with a plain glass of water first thing in the morning or when you are up for the rest of the day. You must not lie down or eat or drink anything else for 30-60 minutes, depending on the specific medicine. You must take your calcium later. Further instructions on how to take bisphosphonates appear in Questions 57 to 60.

Adherence with taking any medication prescribed for you is very important. A recent study showed that the majority of women stop taking their prescribed bis-phosphonate medication before one year is up and, although weekly dosing was better, many on weekly dosing still did not stick to their medication regimen. The researchers speculate that there are two reasons why women don't stay on their bisphosphonate medication regimens. First, osteoporosis is a chronic disease, but you can't see it or feel it unless you fracture a bone, so it may be difficult to justify the expense for medications and establish the ongoing routine for taking them. Secondly, because it is necessary to follow strict guidelines when taking the medication either daily or weekly, sticking to the regimen can be trying. The obvious downside to not taking your medication regularly, whether it's a bisphosphonate or something else, is that you will not benefit from its intended effects. You will not improve your bone mineral density and your fracture risk will continue to increase (see Table 7).

Table 7 Summary of Prescription Medications for Osteopenia and Osteoporosis

Class of Medication

(Products)1

Clinical Uses

Considerations

Bisphosphonates

(Actonel, Boniva, Fosamax)*

Osteoporosis • Caution if allergic; upper gastrointestinal prevention and disease (e.g., ulcers or reflux) or kidney treatment disease

• Take first thing in the morning on an empty stomach with a full glass of water, remain upright and take no other food or drink for at least 30 minutes to 1 hour depending on which bisphosphonate

• Dosing schedules are dependent on the products (some can be taken daily, once per week, or once per month)

• Do not take antacids/calcium until 2 hours after taking bisphosphonates

• May cause inflammation of stomach or esophagus; nausea; vomiting; constipation; diarrhea; flatulence; ulcer; swelling; abdominal, muscle, back, or joint pain; or (rarely) osteonecrosis of the jaw after dental surgery

• Bisphosphonates are not a substitute for calcium and Vitamin D; both are critical to successful treatment with bisphos-phonates

Calcitonin (Miacalcin NS, Fortical)*

Osteoporosis &

vertebral fractures

Administered as a nasal spray

Probably has pain relieving effect on fractures due to osteoporosis

Caution if allergic

May cause spasms of large airways, nausea, vomiting, flushing, rash, itching, warmth, nighttime urination, eye pain, reduced appetite, swelling, abdominal pain, salty taste

100 Q & A ABOUT OSTEOPOROSIS AND OSTEOPENIA Table 7 Summary of Prescription Medications for Osteopenia and Osteoporosis (cont.)

Class of Medication

(Products)± Clinical Uses Considerations

Estrogen therapies+

(e.g., Activella, Alora, Climara, Estrace, Estraderm, Estratab, Femhrt, Menest, Ortho-prefest, Premarin, Vivelle, Vivelle Dot, others)*

Prevention of osteoporosis (for women only)

Should be prescribed for prevention of osteoporosis only if moderate-to-severe hot flashes and night sweats are present Also effective in alleviating most symptoms of menopause Improves balance and reduces falls Comes in several forms (i.e., pills, patch, ring, cream, gel)

May cause vaginal bleeding/ spotting; breast changes/tenderness; bloating/cramps; weight changes; nausea; vomiting; headache; swelling; elevated blood pressure; hair changes; rash; vaginal yeast infections; vision changes; difficulty wearing contact lenses; and, rarely, depression; uterine fibroid growth; worsening of asthma; blood clots; stroke; heart attack; dementia; cancers of the breast, ovaries, or uterine lining; problems with gallbladder, liver, or pancreas May not be used in combination with Evista (one combination of a new SERM and estrogen is currently being investigated)

Low-dose estrogen patch (Menostar)*

Prevention of osteoporosis (for women only)

Very-low-dose estrogen patch specifically tested and prescribed for preventing osteoporosis, but probably won't provide relief for hot flashes because the dose is so low

All contraindications and side effects of estrogen apply to use of medication

May not be used in combination with Evista or other estrogen therapies

Does not improve BMD as much as higher-dose estrogen products

Table 7 Summary of Prescription Medications for Osteopenia and Osteoporosis (cont.)

Class of Medication

(Products)±

Clinical Uses

Considerations

Raloxifene (Evista)*

Prevention and treatment of osteoporosis (for women only)

Only selective estrogen-receptor modulator (SERM) available for osteoporosis prevention and treatment

Cannot be taken with MHT (menopause hormone therapy) Caution if allergy, blood clots, high triglyceride levels, using hormone therapy

May cause hot flashes, infection, flu-like symptoms, joint pain, sinusitis, nausea, weight gain, inflammation of mouth/throat, depression, cough, leg cramps, rash, insomnia, stomach upset, or clots

Teriparitide

Osteoporosis

• Only FDA-approved anabolic

(Forteo)*

treatment

(bone-building) medication

• Given by daily injection at home

• Usually used only if other treatments are ineffective or not tolerated

• Caution if allergy, bone cancer, history of radiation to bone, urinary stones, parathyroid disease, bone disease,

• May cause low blood pressure, dizziness, weakness, joint pain, leg cramps, fainting, chest pain

Note: AH medications have associated benefits, risks, and side effects. These should be discussed with your clinician before starting any medication.

Prescription medications are not a substitute for taking calcium and Vitamin D. You must take the appropriate amount of calcium and Vitamin D regardless of medication regimen (see Tables 3 and 6).

+Some estrogen products listed contain progestin as well as estrogen. *See individual tables for Actonel (Table 9), Boniva (Table 10), Fosamax (Table 8), Evista (Table 12), Forteo (Table 13), Menostar (Table 15), Miacalcin NS/Fortical (Table 14), and estrogen therapies (Table 16).

Note: AH medications have associated benefits, risks, and side effects. These should be discussed with your clinician before starting any medication.

Prescription medications are not a substitute for taking calcium and Vitamin D. You must take the appropriate amount of calcium and Vitamin D regardless of medication regimen (see Tables 3 and 6).

+Some estrogen products listed contain progestin as well as estrogen. *See individual tables for Actonel (Table 9), Boniva (Table 10), Fosamax (Table 8), Evista (Table 12), Forteo (Table 13), Menostar (Table 15), Miacalcin NS/Fortical (Table 14), and estrogen therapies (Table 16).

Certain groups of people should receive prescription medications for the prevention and treatment of osteoporosis. According to the American College of Rheumatology, bisphosphonates (see Questions 57-59) should be prescribed to the following groups who are receiving glucocorticoid therapy (such as for rheumatoid arthritis, asthma, inflammatory bowel disease, or lupus):

• To prevent bone loss in individuals in whom long-term glucocorticoid (steroid) treatment (doses of 5 mg or more per day) has been initiated

• Patients who already have GIO with documented low bone mineral density or recent fracture

• Patients receiving glucocorticoids who have sustained fractures while on estrogen therapy or in whom estrogen therapy has not been well tolerated.

57. I was prescribed Fosamax (alendronate). What is that? What are the contraindications to taking it, and are there any side effects? I've heard that Fosamax can be very tough on the stomach. Is that true?

Fosamax (alendronate) is one of the bisphosphonates, a group of drugs used to treat or prevent osteoporosis as well as to prevent bone loss in early post-menopausal women. Fosamax does this by decreasing bone turnover. Fosamax and the two other FDA-approved bisphosphonates for treating or preventing osteoporosis—Actonel® (risedronate) and Boniva® (ibandronate)—don't actually build bone, but they are very effective in preventing further breakdown of bone. By slowing bone turnover, bone mineral density increases. In fact, bisphosphonates can decrease spinal fracture risk in as little as one year of treatment. A fourth bisphosphonate, Didronel® (etidronate), also affects bone turnover and is FDA-approved for the treatment of Paget's disease. Questions 58 to 60 discuss Actonel, Boniva, and Didronel.

Fosamax is FDA-approved for prescription daily or once-a-week in different doses for the purposes of preventing or treating osteoporosis in postmenopausal women, treating to increase bone mass in men with osteoporosis, or for the treatment of glucocorticoid-induced osteoporosis (GIO) in men or women with low bone mineral density who are receiving daily doses of glucocorticoids >7.5 mg. The dosage of Fosamax for GIO is one 5-mg tablet by mouth per day for men and women or 10 mg per day for postmenopausal women who are not taking estrogen. The bone mineral density in individuals with GIO significantly increases after about one year of treatment using Fosamax. Either the 5 mg per day dose or one 35-mg tablet by mouth once a week is used to treat postmenopausal women with osteopenia because the goal of osteopenia treatment is osteoporosis prevention. For the treatment of osteoporosis in postmenopausal women or to increase bone mass in men with osteoporosis, the dosage is one 10-mg tablet per day or one 70-mg tablet once a week. A month's supply of tablets, whether taken daily or weekly, costs about $80 without insurance coverage or co-pays.

Results of a six-year study showed that women taking Fosamax and women taking EPT (estrogen-progestin therapy) both had increases in bone mineral density. Fosamax and EPT were discontinued after four years and once again, bone mineral density decreased in all of the postmenopausal women. However, those who had taken Fosamax had less bone loss after two years than those who took EPT.

Yes, it's true that Fosamax can be tough on your stomach, and if you already have stomach ulcers or reflux disease, it should be used with extreme caution. Stomach upset and the risk for ulcers is further increased if you are taking non-steroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (e.g., Motrin, Nuprin), naproxen (e.g., Aleve), or aspirin while you are on Fosamax. You can minimize the negative effects such as heartburn and stomach upset by following strict guidelines. Whether you take Fosamax daily or weekly, you must take it using these same guidelines:

• If you are on the weekly version of Fosamax, pick a day and stick with it. Most people pick Sunday unless they are too tempted to go back to sleep. Fos-amax tablets come with tiny stickers to put on your calendar as reminders to take it. If you happen to forget to take it on the day it is due (e.g., Sunday), then take it the very next day (e.g., Monday).

• Take it on an empty stomach. Food interferes with its absorption. So does any liquid except PLAIN water.

• You must swallow the tablet whole. Do not chew or suck on it.

• When you are up for the day (meaning that you are not going to lie down after taking it), take the tablet with a 6- to 8-ounce glass of PLAIN water, not seltzer water, not fruit-flavored water, and not any other beverage made with water. Never take Fos-amax before retiring for the night. Only take it with plain water.

• Take nothing else for at least 30 minutes. Do not take calcium, Vitamin D, or antacids within 2 hours of taking Fosamax.

Do not lie down or bend at the waist. Don't go back to bed. Bending at the waist or lying down can make the medication reflux into your esophagus and increase the chance of heartburn. You may eat and take other medications after 30 minutes, except those mentioned above.

Bisphosphonates may cause inflammation of the stomach or esophagus, nausea, vomiting, constipation, diarrhea, flatulence, ulcer, swelling, or abdominal, muscle, back, or joint pain. Although rare, osteonecrosis of the jaw (deterioration of bone tissue) following dental surgery has been reported in patients taking long-term bisphosphonate therapy. Most reports were in patients taking intravenous bisphosphonate therapy, but a few were in those taking the medications orally. It is important to inform your dentist if you are taking or have previously taken bisphosphonates.

Osteonecrosis of the jaw

Deterioration of jaw bone associated with tooth loss, local infection, and delayed healing; leads to death of local jaw bone tissue.

Fosamax is strictly contraindicated if you have an allergy to bisphosphonates or advanced kidney disease. Caution should be used when Fosamax is taken by anyone with existing stomach or intestinal disease. Table 8 summarizes the contraindications and considerations for taking Fosamax. While the majority of Fosamax's side effects are related to heartburn, you should always immediately report chest pain, difficulty swallowing, or severe midline heartburn.

The FDA recently approved Fosamax Plus D, a weekly tablet that contains the same 70 mg of alendronate found in the weekly Fosamax tablet, but also has added Vitamin D. The 2,800 IU of Vitamin D in Fosamax Plus D is the typical weekly amount recommended for people aged 51 to 70. If you are over the age of 70, you will need to make sure that you still get an additional

Trade Name

(Generic Name)

Most Common

[Manufacturer]

Side Effects and

How Supplied

Clinical Uses

Contraindications Adverse Reactions

Fosamax, Fosamax Plus D (alendronate) [Merck]

70 mg tablet as Fosamax Plus D (2,800 IU Vitamin D)

Postmenopausal women at risk for developing osteoporosis

Postmenopausal women or men who have osteoporosis

Men and women who are taking >7.5 mg of glucocorticoids daily and who have low bone density

Paget's disease in men and women

Allergy to bisphosphonates

Esophageal abnormalities

Low blood calcium Poor kidney function

Inability to remain upright for 30 minutes

GI: acid reflux, nausea, vomiting, diarrhea, abdominal pain, flatulence, esophageal ulcer

Bone or muscle pain

Get immediate help for difficulty swallowing, midline chest pain, severe vomiting or severe abdominal pain

Special

Considerations

Take first thing after rising for the day on an empty stomach with a full glass of plain water, remain upright and take no other food or drink for at least 30 minutes

Can be taken weekly in some instances

Use caution if upper gastrointestinal disease (e.g., ulcers or reflux) or kidney disease

Found to be safe up to 10 years of use

Do not take calcium, other minerals, or milk products within 2 hours of taking Fosamax

Compliance with medication schedule important to increasing BMD Fosamax Plus D contains 2,800 IU of Vitamin D, a weeks worth of Vitamin D for individuals aged 51 to 70

If prescribed by a specialist for women of childbearing age, they must be on an effective method of birth control and counseled about the unknown long-term effects on future pregnancy

If you are taking Fosamax Plus D, it may still be necessary to take a daily supplement of Vitamin D (see Table 3 for the RDA for your age)

RDA of calcium and Vitamin D are also important for increasing BMD, both are needed on the day Fosamax is taken (at least 2 hours after Fosamax)

In very rare cases could increase the risk for osteonecrosis of the jaw following dental surgery

200 IU per day of Vitamin D. Table 8 reviews the indications and considerations for using Fosamax.

The long-term safety of Fosamax has been established in those taking it for 10 years or more. Several studies have shown that bone density does increase, and safety is maintained in patients who take Fosamax for >10 years. Additionally, some bone protection persists even after Fosamax is stopped in those who have taken it for 5 years continuously.

The long-term effects of Fosamax could be a concern even after it is discontinued. The half-life of Fosamax can exceed 10 years. This means that it can take a very long time for the body to eliminate all of the Fosamax that has been absorbed. Effects on bone are likely to be positive, but it is not clear how a future pregnancy would be affected by the continued effects of Fosamax or other bisphosphonates. Fosamax is not FDA-approved for use in premenopausal women except those with GIO. If a premenopausal woman had a fragility fracture (see Question 74), a specialist may consider treatment with a bisphospho-nate. This would only be considered if other potential causes for the fracture were ruled out and if she were on a very reliable method of birth control or unable to conceive.

Half-life

Time it takes the body to metabolize or inactivate half of the amount of a medication that was taken.

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