Are there any medications that are available without a prescription to treat osteoporosis?
Vitamins, minerals, and dietary supplements can be sold over the counter (OTC)—that is, without a prescription. These products can be purchased in drug stores, health food stores, some department stores, and over the Internet. The FDA does not regulate OTC products as they do prescription medications. Because of this, certain claims can be made without clinical trials or scientific evidence to support the claims. Therefore, you should be aware of what you're buying and do some research in advance. The ConsumerLab Web site (consumer-lab.com) provides an excellent resource for the contents of many products containing vitamins, minerals, herbals, and dietary supplements. The ConsumerLab site reports the results of independent testing to evaluate manufacturers' claims and the presence of amounts of ingredients in the tested products.
Rimostil (see Question 54) is an isoflavone preparation intended to improve bone density. It is sold in stores and over the Internet. Rimostil is manufactured by Novogen, a pharmaceutical company. There is some evidence that isoflavones from red clover can increase bone density. Novogen's other red clover isoflavone product is Promensil™. Some women say that Promensil gives them relief from hot flashes.
There has been little long-term testing of phytoestrogens such as the isoflavones found in red clover; however, some short-term small studies indicate that they may have a place in improving bone health. If you are looking for a nonprescription way of trying to improve bone density, Rimostil or Promensil may be options for you. However, you should discuss this choice with your clinician. Because Rimostil is made from isoflavones, which are phytoestrogens, it's important to remember that the contraindications to estrogen apply to Rimostil and Promensil as well (history or presence of breast cancer, estrogen-dependent cancers, history of clots, unexplained uterine bleeding). You also need to be aware that these products may not mix well with prescription medications for bone health such as Evista or estrogens.
OsteoSine®, manufactured by NuLiv and taken as two capsules per day, contains vitamins, minerals, and a blend of ingredients made from cuscuta chinensis, an herb that contains flavonoids (the substances in red wine that are believed to contribute to reducing the risk of heart disease). The manufacturer of OsteoSine claims bone health can be improved, but this has not been tested in large clinical trials. To the extent that OsteoSine does contain vitamins and minerals necessary to support good bone health, its claims could be true. Should you decide to go this route, be wary of any unusual rashes or reactions, which may indicate that you are allergic to one of the ingredients that are not specifically named on the label. And as always, make sure that your clinician is aware of any OTC medication you are taking.
Calcium and vitamin D, the most important mineral and vitamin for promoting bone health, are the most accessible OTC treatments and preventive measures for osteoporosis. Don't forget that even if you take adequate amounts of both and exercise properly, you still may not avoid bone loss, especially if you are a woman at or past menopause (see Questions 46-51).
How long will I be treated for osteoporosis? How will I know if the treatments are working?
Osteoporosis is beginning to get the scrutiny and concern that it deserves. Up to now, osteoporosis has received little attention, possibly because it causes no pain unless you break a bone or possibly because many people associate it with normal aging. Few therapies for osteoporosis have been tested for use for longer than 10 years, except estrogen, which was approved for
Treatment for primary osteoporosis is usually ongoing unless some contraindications to treatment arise.
the prevention of postmenopausal osteoporosis in 1972. Despite this, treatment for primary osteoporosis is usually ongoing unless some contraindications to treatment arise. In the case of secondary osteoporosis, treatment continues until the secondary cause of osteoporosis is remedied or the medication causing osteoporosis is discontinued and bone density testing reveals stable bone mass over time.
The National Osteoporosis Foundation (NOF) recommends repeat BMD testing to monitor bone loss every 2 years. If you are taking medication therapy, the NOF recommends you be tested again 2 years after starting medication and about every 2 years after that. If you are using lifestyle measures alone to prevent bone loss, the NOF also recommends testing about every 2 years for you. The NOF recommends testing for anyone at risk and for those who would start treatment if they knew they had bone loss.
If you have glucocorticoid-induced osteoporosis (GIO) (see Question 15), the Surgeon General recommends retesting every 6 months until bone mass levels are stable. In all cases of monitoring, DXA testing of the hip and/or spine is the most accurate. Peripheral testing (heel or wrist) is not valuable in the assessment of your progress or for diagnosis of osteoporosis. Although some clinicians may use urinary or blood biomarkers to evaluate whether a certain treatment is working, these markers are not currently predictive of the way patients will respond to treatments. Further study is needed to determine which markers clearly indicate whether BMD is increasing and which markers indicate that fracture risk is reduced (see Question 39).
Depending on the type of medication you are on, the extent of bone loss when you were first tested, and how you are tested for improvement will give you some clues as to the length of your treatment and how often you need to be monitored:
Menopause hormone therapy (MHT). If you are on any product containing estrogen, you will need to be reevaluated at least annually to determine if you should stay on it. Typically, if you are on MHT for hot flashes and night sweats or vaginal dryness, your bones are going to benefit from the estrogen regardless of how long you are on it. Based on the WHI results, most clinicians recommend that estrogen or estrogen-containing products be taken for the shortest period of time possible, usually 5 years or less. After that time, it's believed that the risks of breast cancer and stroke go up enough to outweigh the benefits of estrogen. However, that is a decision to be made by you and your clinician. The fastest rate of bone loss occurs in the first 4 to 8 years following menopause, so if you are on MHT for menopausal symptoms, of course you will benefit from its protective effects on bone. Evidence shows that once MHT is stopped, bone loss increases almost immediately, usually at the same rate as before you started MHT. However, one study found that beneficial effects on bone were present several years later among women who had used MHT in the first 2 to 3 years after menopause. Having regular BMD tests will assist you in your decision-making from the standpoint that if you no longer need MHT for moderate to severe menopausal symptoms, you may need another medication if your DXA test shows osteopenia or osteoporosis.
The fastest rate of bone loss occurs in the first 4 to 8 years following menopause.
Bisphosphonates. Fosamax's (alendronate's) safety record is a good one. So far, Fosamax has been tested for up to 10 years of use without significant problems. Once stopped, Fosamax continues its positive effect on bone mass if you had 5 years of continuous treatment. The other bisphosphonates have also been shown to continue their protective effect after the medication is stopped, but studies have been smaller and for shorter duration than those done using Fosamax. Once you are diagnosed with osteopenia or osteoporosis and placed on a medication, in this case a bisphosphonate, you will not know if it's working unless your BMD test is repeated. Your clinician should tell you when you need to be retested. In most cases, you will be retested about 2 years after you begin treatment. According to the American Association of Clinical Endocrinologists (AACE), you should not stop treatment even if there is no improvement or even a slight decrease in BMD after 2 years of treatment. This makes sense when you consider that an increase of 3% to 6% at the hip or 2% to 4% at the spine is needed to be considered a clinical improvement. Differences in testing machines and testers can account for as much as 5% of the change in measurements. Failure to increase or minimally improve bone density is not a reason to stop or change treatment. Usually, treatment with a bisphosphonate is long term, meaning years.
Evista. Evista (raloxifene) was the first estrogen agonist/ antagonist to be approved for the treatment of osteoporosis, and its approval depended on many years of testing for safety. While you are on Evista, BMD testing should follow the usual guidelines for testing about every 2 years. Most of the clinical trials based their results on 3 to 4 years of treatment and established an acceptable safety level during those trials to achieve FDA approval for use. So, while it is not clear at this time how long Evista can be taken, it appears safe for at least 4 years. But remember, once you stop taking it, your bone mass will start to decrease again.
Calcitonin preparations. Miacalcin NS and Fortical (calcitonin) are usually reserved for women who are at least 5 years postmenopause and in whom estrogen therapy is not advised or desired, but they can be used in combination with MHT. Miacalcin NS or Fortical are usually prescribed following a vertebral fracture and most often for pain relief. The effects of calcitonin nasal spray can be monitored by DXA retesting. After 2 years of treatment, there generally is no further increase in bone mass. Although there are no specific standards for monitoring due to the very small changes in bone density that occur with calcitonin preparations, those using calcitonin nasal spray should be monitored about every 2 years. Urinary markers as indicators of improved BMD have not been tested in women using calcitonin nasal spray.
Forteo. Although measurements of BMD were taken after only 3 months in Forteo study participants, your clinician may want to monitor your progress after 1 year of treatment. Using Forteo for longer than 2 years is not recommended because the long-term safety of its use has not been established. A 10-year study of Forteo is under way because the FDA has required a "black-box warning" advising that Forteo may cause a rare form of bone cancer. Your clinician may advise more frequent monitoring of your bones until the results of the 10-year study are known.
Before you leave your clinician's office with a prescription, be sure to find out the expectations in terms of retesting and monitoring your progress.
