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In women with osteoporosis, pharmacologic treatment should last for 5 years; generic drugs should be used when possible. Monitoring of bone mineral density BMD during the 5 years of treatment in women with osteoporosis is not advised, as evidence suggests that fracture risk may be reduced regardless of BMD changes. For women aged 65 and older who have osteopenia and are at high fracture risk, decisions to treat should take into patient preference, fracture-risk profile, benefits, harms, and price of medications.
In men with clinically recognized osteoporosis, clinicians should offer bisphosphonate therapy to reduce the risk of vertebral fracture; evidence is lacking on BMD monitoring in men. Nonpharmacologic preventive measures include modification of general lifestyle factors, such as increasing weight-bearing and muscle-strengthening exercise, which epidemiologic studies have linked to lower fracture rates, and ensuring optimum calcium and vitamin D intake as adjunct to active antifracture therapy.
There may be an Older women seeking younger men Dinant risk of fractures involving adjacent vertebrae if therapies including vertebroplasty or kyphoplasty were used in the management of painful osteoporotic fractures . A literature review suggested that the use of "reminders plus education targeted to physicians and patients" can lead to increased BMD testing and greater use of osteoporosis medications. The authors concluded that multicomponent tools aimed at doctors and patients may support clinical decision making in the management of osteoporosis.
A study indicated that the use of a case manager for the treatment of patients with hip fractures can lead to more frequent use of appropriate osteoporosis treatment and may result in fewer fractures, increased life expectancy, and ificant health-care cost savings. In patients who have experienced an osteoporotic fracture, the first goal of rehabilitation is to control pain. Spinal compression fractures can be extremely painful and can cause short- and long-term morbidity. Oral analgesics can be implemented. Calcitonin may rarely help acute pain associated with acute osteoporotic vertebral compression fractures.
During this period, monitoring the patient carefully for s of constipation, urinary retention, and respiratory depression, which can occur with the use of narcotic analgesics, is essential. Orthotics may be used to decrease the flexion forces to prevent the worsening of kyphosis and to reduce the pressure on the fracture site in the acute phase of disease.
Currently, no treatment can completely reverse established osteoporosis. Early intervention can prevent osteoporosis in most people.
For patients with established osteoporosis, medical intervention can halt its progression. If secondary osteoporosis is present, treatment for the primary disorder should be provided. Patients identified as at risk for osteoporosis including children and adolescents should undergo preventive measures, including adequate calcium intake, vitamin D intake, and exercise. Patients should be counseled to avoid tobacco and excessive alcohol use.
Protective measures should be taken in patients who must take glucocorticoids for other medical conditions. These include using the minimum effective dose of glucocorticoid and discontinuing the drug as soon as possible. The American College of Rheumatology provides recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis, which were updated in Bisphosphonates are the most commonly used agents for osteoporosis.
Oral and intravenous options are available. Alendronate Fosamax is approved for the treatment of osteoporosis in men, in postmenopausal women, and in patients with glucocorticoid-induced osteoporosis. It has been shown to increase spine and hip bone mineral density in postmenopausal women. Alendronate is also available in combination Older women seeking younger men Dinant cholecalciferol vitamin D3. The combination of alendronate with vitamin D3 Fosamax Plus D is indicated for the treatment of osteoporosis in men to increase bone mass.
The oral bioavailability of alendronate is drastically reduced when taken with food, even black coffee or orange juice alone. Other oral bisphosphonates include risedronate Actonel or risedronate delayed-release Atelviagiven daily, weekly, or monthly. Ibandronate Boniva is another bisphosphonate that can be given orally once a month Older women seeking younger men Dinant is also available as an intravenous formulation that is given every 3 months.
Intravenous bisphosphonates are excellent choices for patients intolerant of oral bisphosphonates or for those in whom adherence is an issue. However, ibandronate has not shown efficacy in nonvertebral fractures in clinical trials. Zoledronic acid Reclast is a once-yearly intravenous infusion approved for the treatment of osteoporosis in men, in postmenopausal women, and in patients with glucocorticoid-induced osteoporosis. It increases BMD at the spine by 4. A similar effect on vertebral fractures has been shown in men.
A randomized, placebo-controlled, double-blind trial suggested that a once-yearly 5-mg dose of IV zoledronic acid increases bone mass in men within 90 days of hip fracture repair; similar increases were noted in women. Over time, bisphosphonate therapy decreases bone turnover and, at very high levels in animals, decreases bone strength and resilience. Some limited reports, including that by Odvina et al, describe patients on long-term bisphosphonate therapy developing transverse stress fractures; biopsy specimens of these individuals have suggested extremely low turnover states in some of them.
Alendronate and risedronate inhibit bone resorption at doses fold lower than those reducing osteoclast. Thus, suppression of bone resorption with these agents is independent of their effects on apoptosis. In Septemberthe US Food and Drug Administration FDA updated the prescribing information for zoledronic acid to provide improved information regarding the risk of kidney failure. Acute kidney injury requiring dialysis and fatal outcomes have been reported to the FDA following the use of zoledronic acid.
Risk for renal impairment is also increased by the following [ ] :. In Marchthe FDA made safety labeling changes for bisphosphonates, including zoledronic acid, to advise of the risk for atypical subtrochanteric and diaphyseal femoral fractures in patients who have received bisphosphonate therapy, including zoledronic acid. These fractures occur with minimal or no trauma and may present as groin pain weeks to months after fracture. The FDA also includes a safety warning for bisphosphonates, including zoledronic acid, regarding the risk for osteonecrosis of the jaw ONJ.
The incidence of ONJ in patients on antiresportive therapy for osteoporosis is estimated to be between 1 in 10, and 1 inper year of use; this risk is only very minimally, if at all, increased compared with the general population. In contrast, the use of IV bisphosphonates and denosumab in cancer patients to reduce complications of metastatic cancer in substantially higher cumulative doses administered given increased dose and frequency used for these indications ; therefore, atypical femoral fractures and ONJ are more commonly seen when IV bisphosphonates or denosumab are used as part of cancer treatment.
In Novemberthe FDA made safety labeling changes for zoledronic acid to warn against the following adverse reactions [ ] :. Hypersensitivity reactions presenting as bronchospasms; interstitial lung disease ILD with positive re-challenge.
The limited trial data available regarding long-term treatment with bisphosphonates has raised questions about the optimal length of treatment with these medications. Some studies have sought to clarify the true risks of complications in patients receiving bisphosphonates. A Canadian study by Park-Willie et al found the estimated absolute risk of a subtrochanteric or femoral shaft fracture to be low in 52, women with at least 5 years of bisphosphonate therapy 0.
Patients at high risk may be continued on bisphosphonates after 5 years; however, in some patients, especially those with a lower risk of fracture, bisphosphonate treatment may be stopped for a period with subsequent reassessment of fracture risk, often termed a "drug holiday. The AACE recommends that if fracture risk is no longer high or the patient has remained fracture free, clinicians should consider a drug holiday after Older women seeking younger men Dinant years of bisphosphonate treatment; treatment should continue up to an additional 5 years if fracture risk remains high.
For high fracture risk patients, a drug holiday may be considered after years of treatment. For zoledronate, consider a bisphosphonate holiday after 3 years in high-risk patients or until fracture risk is no longer high, and continue for up to 6 years in very-high risk patients. The ending of a bisphosphonate holiday should be based on individual patient circumstances. BMD and bone turnover markers should be monitored, and treatment should be restarted when the density declines substantially, bone turnover markers increase, or an increase in fracture risk or fracture occurs.
Inthe American Society for Bone and Mineral Research published guidelines on long-term bisphosphonate treatment that included the following recommendations [ ] :. Selective estrogen receptor modulators SERMs are considered to provide the beneficial effects of estrogen while mitigating the potentially adverse outcomes. Raloxifene Evista is a SERM indicated for the treatment and prevention of osteoporosis in postmenopausal women. The usual dose is 60 mg given orally daily. It can also be given in combination with calcium and vitamin D.
It is the first SERM studied for breast cancer prevention, and it decreases bone resorption through actions on estrogen receptors. It has also been shown to reduce the prevalence of invasive breast cancer. However, raloxifene is not without risk; it has been shown to increase the incidence of deep vein thrombosis, stroke, and hot flashes.
Raloxifene may be most useful in younger postmenopausal women without severe osteoporosis.
In postmenopausal women who had daily therapy with raloxifene, BMD was increased, serum concentrations of total low-density lipoprotein cholesterol were lowered, and the endometrium was not stimulated.
The primary reduction was in noncardiovascular, noncancer deaths. Increased risk of deep vein thrombosis, pulmonary embolism, and death due to stroke have been seen in trials with raloxifene and this must be weighed against potential benefit to patient for osteoporosis when considering prescribing raloxifene or other SERMs. The combination product of bazedoxifene, a SERM, and conjugated estrogens CEs is approved by the FDA for prevention of osteoporosis and treatment of vasomotor symptoms in postmenopausal women.
This eliminates the need for a progestin and its associated risks eg, breast cancer, myocardial infarction, venous thromboembolism. In clinical trials, this combination decreased bone turnover and bone loss in postmenopausal women at risk for osteoporosis. Teriparatide Forteo is a recombinant human parathyroid hormone PTH  that acts as an anabolic agent for the treatment of osteoporosis.
It is indicated for the treatment of women with postmenopausal osteoporosis who are at high risk of fracture, who have been intolerant of osteoporosis therapy, or in whom osteoporosis treatment has failed to increase bone mass. It is indicated in men with idiopathic or hypogonadal osteoporosis who are at high risk of fracture, who have been intolerant of osteoporosis therapy, or in whom osteoporosis therapy has failed. Teriparatide is also approved for the treatment of patients with glucocorticoid-induced osteoporosis. Teriparatide cannot be given for more than 2 years total in a lifetime due to concerns for increased risk of osteosarcoma; higher incidence of osteosarcoma was seen with high doses in animal studies.
However, evidence to show an increased risk of osteosarcoma in humans receiving therapeutic doses of teriparatide has not been obtained.
When PTH is given continuously, both osteoclastic and osteoblastic turnover increase, leading to a net loss of bone. Indications for PTH in men and women are a bone density decline while on bisphosphonate therapy, bone density stabilization while on extremely low-level bisphosphonate therapy, a fracture occurring while on bisphosphonate therapy, or a very low initial bone turnover rate for which an anabolic effect is clearly warranted. Teriparatide should be considered in younger and older postmenopausal women with severe osteoporosis.
Most studies with PTH have been performed on women. The medication decreases the risk of vertebral and nonvertebral fractures to the same extent as bisphosphonates. Teriparatide is given for a maximum of 2 years, after which time the gains in BMD achieved with PTH are secure and can even be augmented with bisphosphonate therapy; otherwise, the BMD slowly deteriorates to pretreatment levels. According to Finkelstein et al, initial studies using a combination of concurrent PTH and bisphosphonate Older women seeking younger men Dinant showed decreased benefit compared with therapy with either agent alone; therefore, the general recommendation is that these drugs be given separately and in sequence.
A study by Cosman and colleagues challenged this conclusion by giving 3-month-on, 3-month-off pulses of teriparatide while the patients were on weekly alendronate; BMD in the spine increased above that of the alendronate-only arm. Studies in women by Deal et al and Ste-Marie et al have shown that the concurrent use of estrogen or raloxifene can enhance the bone-forming effects of teriparatide.
In a randomized, controlled trial DATA94 osteoporotic postmenopausal women were randomized to take 24 months of teriparatide or denosumab alone, or teriparatide and denosumab in combination. Those women taking teriparatide and denosumab in combination had increased BMD after 12 months. The month changes in posterior-anterior lumbar spine, femoral neck, and total hip BMD in the combination-therapy group 9.
As an extension to this study DATA-Switchwomen originally ased to teriparatide received denosumab after 24 months and those originally ased to denosumab received teriparatide. Switching from teriparatide to denosumab yielded progressive BMD increases, whereas switching from denosumab to teriparatide resulted in progressive or transient bone loss. In a retrospective analysis of the data from the Fracture Prevention Trial and the Multiple Outcomes of Raloxifene Evaluation trial, Bouxsein et al found that teriparatide reduced fracture risk to a greater extent than raloxifene in postmenopausal osteoporotic women.
A double-blind, double-dummy trial by Kendler et al found that in postmenopausal women with severe osteoporosis, the risk of new vertebral and clinical fractures was ificantly lower in patients receiving teriparatide than in those receiving risedronate. Study subjects had experienced at least two moderate or one severe vertebral fracture and had a BMD T-score of At 24 months, new vertebral fractures had occurred in 28 5.
Clinical fractures occurred in 30 4. Use of teriparatide for atypical fractures has not been studied in large randomized controlled trials due to the small s of atypical fractures. Gomberg et al reported a case of successful healing of bilateral subtrochanteric stress fractures in a postmenopausal woman who had used a bisphosphonate for 13 years. For ONJ, teriparatide may be a useful adjunctive therapy. Three cases have been reported in which teriparatide has been used successfully in patients with bisphosphonate-associated ONJ. The absolute risk reductions were 3. The benefits were evident regardless of age, years since menopause, presence or absence of prior fracture vertebral or nonvertebraland BMD at baseline.
A study performed by an Austrian group using PTH to treat pelvic fractures in postmenopausal women with Older women seeking younger men Dinant demonstrated that this anabolic agent has the ability to both increase the rate of union and enhance the speed of the process. In addition to improved fracture healing, treatment with PTH was also associated with a ificant decrease of pain and improved function over the placebo arm. This clinical study supports the extensive animal data that predicted a clear role for PTH in fracture repair.
Romosozumab Evenity is a monoclonal antibody that binds with and inhibits sclerostin, and thus both increases bone formation and decreases bone resorption.
It was approved by the FDA in for treatment of osteoporosis in postmenopausal women who are at high risk for fracture. It has been shown to reduce vertebral fracture rates in postmenopausal women with osteoporosis. A further reduction in vertebral fracture risk occurred in the second year following transition to denosumab. Romosozumab is also being investigated in men with osteoporosis.Older women seeking younger men Dinant
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The Role of Androgens and Estrogens on Healthy Aging and Longevity