_______________________________________________________ Osteoporosis: Diagnosis and Management
Romosozumab-aqqg has a boxed warning regarding an increase in the risk of heart attack, stroke, and cardiovascular death, and it should not be used in patients who have had a heart attack or stroke within the previous year. Other possible adverse effects include joint pain, headache, and injection site reactions [74]. Sodium Fluoride Sodium fluoride is not currently a recommended treatment for osteoporosis based on the data available as well as significant side effects, including hyperostosis, gastrointestinal irritation, rash, and various neurologic complications. However, sodium fluoride does increase osteoblastic activity and has been shown to cause an increase in spine and hip bone mass [20; 123]. Initially, the new bone formed is poorly mineralized, but eventually it is replaced by the lamellar bone structure. Its effect on trabecular bone is more prominent than cortical bone. Significant effects on the rate of vertebral fracture have not been shown in any studies [21]. Vitamin D Analogues Vitamin D causes increased gastrointestinal absorption of calcium, a function that is generally impaired in the elderly. Results from trials have shown decreased fracture rates in older patients taking vitamin D; it is often given in combination with calcium supplements in these patients [20]. The main concern with vitamin D supplementation is hypercalcemia, so calcium levels must be monitored. Vitamin D analogues also may cause gastrointestinal symptoms, erythema multiforme, and hyperphosphatemia. As noted, the common recommended daily dose of vitamin D is 800–1,000 IU, although there is not a clear consensus as to the optimal dose. Evidence indicates that higher intakes are safe and that some elderly patients will need at least 2,000 IU daily to maintain optimal serum levels [20; 49]. As previously stated, the safe upper limit for vitamin D intake was increased in 2010 to 4,000 IU daily for adults [60]. Calcitriol is a synthetic vitamin D analogue that has been approved by the FDA for managing hypocalcemia and metabolic bone disease in patients on renal dialysis, as well as for those with hypoparathyroidism [73]. There has not been a demonstrated reduction in osteoporotic fractures from the use of calcitriol [123]. Strontium ranelate is an investigational drug that inhibits bone resorption and stimulates bone formation [129; 130]. Large trials of strontium ranelate use in postmenopausal women with osteoporosis have shown a 40% to 50% reduction in the risk of vertebral fractures as well as a reduction in the risk of nonvertebral fractures; a separate review of the drug’s efficacy concluded that it reduced vertebral fractures in postmenopausal women both with and without osteoporosis [131; 132; 133; 134; 135]. An open-label study examined the efficacy of strontium ranelate over 10 years in postmenopausal women with osteoporosis. Results indicate a continuous increase in BMD over the 10-year period and a lower incidence
of both vertebral and nonvertebral fracture with use of strontium ranelate compared to placebo [136]. However, debate continues about whether the drug’s effects on the vascular and neurologic systems are sufficient to limit or abandon its use [137]. Other agents, such as insulin-like growth factors and bone morphogenic proteins, are also undergoing further research. Some data have suggested that medications to treat osteoporosis have been underused and that too little of what has been learned about bone health has been applied in practice [23]. Reasons for such low treatment rates include lack of knowledge of the recommended therapies and inappropriate work-up following a fracture diagnosis. Patient D’s T-score from DXA of the hip is -2.5; she meets the WHO criteria for osteoporosis. Given that she is already experiencing symptoms, intervention is necessary. A review of diet is the first step. Patient D currently does not use any supplements because she believes she eats a healthy diet. However, further review with a dietitian reveals that she is below the recommended intake of calcium and vitamin D. Therefore, supplementation with both calcium and vitamin D should begin immediately. As noted earlier, Patient D tries to remain active, mostly involved in walking and gardening. These can be good aerobic exercises, depending on their intensity, and she should be encouraged to continue them. However, a weight-bearing exercise regimen should slowly be worked into her routine. Because she does have degenerative joint disease, a monitored exercise program should be initially pursued so that she focuses properly on form and does not cause any excess stress on her joints. Medications should also be strongly considered, given her T-score as well as symptoms. SERMs and bisphosphonates should be the preferred medications. Estrogen replacement is not recommended.
TREATMENT MONITORING AND FOLLOW-UP
Because medications have side effects and proper diet/exercise may not be routinely followed, it is important to monitor treatment with BMD testing and to consider evaluating the level of the biochemical markers. There is no universally accepted agreement on treatment monitoring, including the utility of biochemical markers; however, some authorities have provided suggested guidelines for following patients being treated for osteoporosis [20; 36]. It has been noted that most treatment measures will produce minor increases in bone mass over the period of one year and that improvement may not be evident until after 24 months of treatment. In addition, most measurement errors are around 5%, so there will need to be improvement greater than 5% in bone mass to have any significance. Taking all of this into consideration, monitoring should occur every two years in most cases; however, the interval should be determined according to individual patient status [20; 33; 37].
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