What about the new lowdose hormone patch Menostar estradiol that is used to prevent osteoporosis

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Menostar (estradiol) was FDA-approved in 2004 for the prevention of postmenopausal osteoporosis. It is a dime-sized transdermal patch that delivers about 14 micrograms of estrogen per day. A new patch is applied every week. Because your body absorbs the estrogen from the patch through the skin, you can avoid the liver "first-pass" effect, meaning that the hormone is not metabolized through your liver. Instead, it can go directly into the bloodstream.

The estrogen that is used in this patch is estradiol, one of the three estrogens made by the human body. Estradiol is the one in greatest abundance until menopause. Then levels drop off to near zero. Although estrone continues to be circulated in both men and women, it is not sufficient in quantity to prevent bone loss. Estradiol in Menostar is derived from plants but is bio-identical to the estradiol in the human body, meaning it is the exact, or identical, chemical structure as the estradiol made by your body. While manufactured estradiol is a bio-identical hormone, it still carries with it the same risks and benefits of other manufactured estrogens that have been studied more completely, such as conjugated equine estrogens. (See Questions 64 and 66 for further discussion of the risks and benefits of taking estrogen.)

The blood levels of estrogen resulting from Menostar are high enough to preserve bone but not high enough to treat the vasomotor symptoms of menopause. If you need your symptoms treated, Menostar probably does not provide adequate estrogen levels for you to get relief. The levels of estrogen needed to effectively treat vasomotor symptoms are two to eight times higher than those generated by Menostar.

If you are postmenopausal and want to prevent osteoporosis, or if you have osteopenia and you want to prevent further bone loss, Menostar may be appropriate for you. Menostar is not FDA-approved for osteoporosis treatment. Other treatment options are used instead.

Like all estrogen preparations that are of sufficient strength to raise blood levels, contraindications to Menostar include breast cancer or any estrogen-dependent cancer, history of stroke or heart attack (myocardial infarction), abnormal uterine bleeding, and a history of or current blood clot(s). Table 15 summarizes Menostar.

Trade Name

  • Generic Name) Most Common
  • Manufacturer] Side Effects and Special

How Supplied Clinical Uses Contraindications Adverse Reactions Considerations

Menostar Osteoporosis

  • estradiol) prevention in
  • Berlex] postmenopausal

Transdermal women patch

(delivers

14 micrograms per day)

Breast cancer

Estrogen-dependent cancer

History of blood clots

Current blood vessel inflammation or blood clot History of stroke or heart attack

Abnormal undiagnosed uterine bleeding

Patch site irritation

Joint pain

Vaginal discharge/

bleeding

Breast changes

Nausea/vomiting

Headaches

Rash

Hair changes

The estrogen used in this patch is plant-derived estradiol, which is bioidentical to the one of the estrogens made naturally in your body

Has half of the estrogen used in other transdermal patches—is successful in the prevention of osteoporosis but does not prevent vasomotor symptoms

Significantly increases bone mineral density after two years

Length of treatment should be weighed carefully with risks associated with all estrogens

Apply new patch weekly

Apply to clean and dry skin, usually the upper arm or on the abdomen; do not apply on or near breast

Not necessary to take progestin regularly, but you should discuss with your clinician the need for taking progestin two times per year for 14 days to allow uterine lining to shed (like a menstrual period); women without a uterus do not need to take progestin

Also see Table 16. All estrogens carry the same contraindications, side effects, and potential reactions.

66. There is a lot of controversy about taking estrogen. Why is that? Should I accept the risks of being on it so that I can prevent further bone loss?

When the Women's Health Initiative (WHI) estrogen-progestin (the participants were taking PremPro) arm of the study was halted in 2002, media concentrated on what caused researchers to stop the study prematurely. The researchers found that the risk of breast cancer, stroke, cardiovascular events, and clots outweighed the benefits of fewer colorectal cancers and fewer hip fractures. In 2004, the estrogen-only arm of the study was also stopped prematurely but not because of the risk of breast cancer. The researchers determined that the risk of stroke and clots was high enough to warrant stopping the study one year earlier than planned.

The increased risk of getting breast cancer while taking daily EPT (0.625 mg of conjugated equine estrogens and 2.5 mg medroxyprogesterone) was reported as 26%. But that kind of statistic is more alarming than helpful. Using the WHI study's design and results, one could predict that of 10,000 postmenopausal women who were taking a placebo, 30 of them would develop breast cancer. If you looked at 10,000 postmenopausal women who were taking EPT for five or more years, 38 of them would develop breast cancer. The difference between 30 and 38 represents a 26% increase, but still only 8 more women out of 10,000 would develop breast cancer. If you happen to become one of the 8 (or 38 total), it's an important statistic to consider when making a decision. However, the media tended to jump on the increased risk of breast cancer; many women, when hearing this news, stopped their hormones cold-turkey. Many clinicians stopped prescribing hormones entirely.

After much more analysis of the WHI data as it applied to the EPT arm, there was more discussion among researchers and clinicians. Three points of view tended to develop from further analysis and discussion. One viewpoint was that the study was faulty in its design and conclusions, so we should not pay attention to the results. For example, the women who took part in the WHI study were well into their postmenopausal years and did not have significant vasomotor symptoms. Questions arise from this observation. Do women earlier in postmenopause develop the same risks? Because breast cancer takes as long as 7 years to develop, another question arises: Is it fair to attribute increased breast cancer risk to taking EPT for only 5 years? The second viewpoint was more absolute. No one should go on hormones or hormones would have to be the last resort for treatment of menopausal symptoms. The third viewpoint falls somewhere in the middle, that the WHI brought important information to light about hormones but that there is still a place for the use of hormones in the treatment of the moderate-to-severe symptoms of menopause.

The controversy has not stopped. The estrogen-alone arm of the WHI showed a small decrease in the risk of breast cancer, which raised questions about the role of progestins in the development of breast cancer. More recently, there was an analysis of many studies in which women used ET or EPT. The result of looking at all of those data showed that estrogen is still an important treatment option for moderate-to-severe menopausal symptoms, and that the risk of death from heart disease or cancer was not increased when MHT is started in the early postmenopausal years.

The decision to use MHT can be a difficult one. With regard to your bones, you should not take it for the treatment of bone loss unless you have moderate-to-severe hot flashes or night sweats that require treatment. The smallest dose that will help your symptoms should be used. Any estrogen used orally or transder-mally (by cream, gel, or patch) will improve your bone density. Using vaginal estrogen for vaginal dryness will probably not provide you with enough estrogen to protect your bones, unless you use a vaginal estrogen ring such as Femring (estradiol). And conversely, using the Menostar patch (estradiol) will not provide you with relief from hot flashes and night sweats, but will provide bone protection.

Although MHT can prevent postmenopausal osteoporosis and is often used together with bisphospho-nates or calcitonin, it is not an approved treatment for osteoporosis. You should use other non-estrogen medications if you already have osteoporosis. When the long-term effects of estrogen therapy were compared with those of Fosamax (alendronate), improved bone mineral density persisted longer in women taking Fosamax. Table 15 (Question 65) describes Menostar and Table 16 summarizes other estrogen therapies.

Before taking MHT, you should consider the possible benefits such as menopausal symptom management (including vasomotor symptoms, vaginal dryness, sleep and mood disturbances, etc.), osteoporosis prevention, and reduced risks for colon cancer as well as potential

Part 1: Clinical Uses, Contraindications, and Common Side Effects of All Estrogen Therapies Listed in Part 2

Clinical uses

  • Postmenopausal women who have moderate to severe vasomotor symptoms and/or vaginal atrophy vaginal dryness
  • Prevention of osteoporosis in postmenopausal women with low bone mass or normal bone density who also have other osteoporosis risks and moderate-to-severe vasomotor symptoms
  • Postmenopausal women with osteoporosis, but only if they also have moderate-to-severe vasomotor symptoms Contraindications
  • Allergy to estrogen or progesterone or components of tablets, capsules, etc.
  • Bi-Est and Tri-Est are contraindicated if you have a peanut allergy
  • Abnormal, undiagnosed uterine bleeding
  • Estrogen-linked cancers; breast cancer; uterine cancer
  • History of blood clots in veins or history of blood clots in arteries within past 12 months
  • Pregnancy
  • Liver problems

Serious adverse reactions (though rare) include: Depression; uterine fibroid growth; worsening of asthma; blood clots; stroke; heart attack; dementia; cancers of the breast, ovary, or uterine lining; problems with gallbladder, liver or pancreas.

More common reactions include: Vaginal bleeding or spotting; slight breast enlargement or thickening; breast soreness; bloating or cramps; weight changes; nausea; vomiting; headache; swelling; high blood pressure; hair thinning or increased hair growth; rash; vaginal yeast infections; vision changes; difficulty wearing contact lenses.

Part 2: Specific Products

Form(s)

Name Product Contents Manufacturer Available Comments o

2= A

Activella

Estradiol and norethindrone

Novo Nordisk

Tablets

Combination of progestin and bioidentical

A B O

acetate

estradiol taken daily

Alora

Estradiol

Watson

Transdermal

Biodentical estradiol

O S

patch

Patch may be cut smaller for smaller dosage

E O

Patch is changed twice a week

P O

Do not apply patch to breast

R O

Bi-Est

Estriol and estradiol

Various manufactur-

Capsules

Bi-Est and Tri-Est contain bioidentical

S S

ers at compounding

hormones manufactured by extracting steroid

A

and

and

pharmacies

molecules from soy and wild yam, an herb

N

Tri-Est

Estriol, estradiol, estrone

Different combinations of the estrogens can be

D

compounded

O

Tell compounding pharmacy if you have

E

a peanut allergy peanut oil is used in the capsules

O

Bi-Est with

Estradiol, estriol, and

Compounding

Capsules

Bioidentical hormones

N

progesterone*

micronized progesterone

pharmacies

Can be compounded in various strengths and

A

Tri-Est with

Estradiol, estriol, estrone

percentages

progesterone

and micronized progesterone

Tell compounding pharmacy if you have

peanut allergy

Ki Os Ki

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Responses

  • erling smallburrow
    Can menostar be started after 70 for osteoporosis prevention?
    4 years ago
  • Kara White
    Where did menostar patch go?
    8 months ago

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