Nnt is a better measure of realistic effect than rrr.

■ Patient-oriented outcomes should take precedence over the disease-oriented outcomes. ■ Denosumab has a different mechanism of action of modern drugs osteoporosis but do not seem to improve patient-oriented outcomes, such as the frequency of fractures. Reducing the cost of some use oral bisphosphonates such as alendronate, is a consideration for many patients. ■ Denosumab is a twice yearly injections, may improve patient adherence, but bisphosphonates zoledronovoyi acid (Reclast, Zometa), once a year injection are also available. ■ Patients with osteoporosis who can not tolerate bisphosphonates should be considered to denosumab treatment. Denosumab (Prolia), the last drug approved to treat osteoporosis, is a type that can be offered safely specialists and primary care physicians alike. Injection, fully human monoclonal antibody (IgG), denosumab is approved by the FDA for the treatment of osteoporosis in postmenopausal women at high risk of fractures. Denosumab inhibits receptor activator of nuclear factor ligand (RANKL), cytokine required for the formation, functioning and survival of osteoclasts. This inhibition stops maturation of osteoclasts and reduces bone resorption. Since osteoclasts break down bone and osteoblasts build bone, reducing the activity of osteoclasts is increased production of new bone and, eventually, bone density. 


The Sixth International Symposium on Osteoporosis said that less dosing may improve patient adherence to treatment. Less than 25% of patients adherent of any osteoporosis medication after 1 year. Unlike other treatments for osteoporosis lasix 14 mg, denosumab is the introduction of twice a year. 


PAs should carefully evaluate the efficacy, safety and value for patients, and priority should be given to the patient outcomes of targeted disease-oriented outcomes. 


Disease-oriented evidence (DOE) primary disease-oriented outcome 
 denosumab therapy is to increase bone mineral density (IPC). Studies have shown that IPC increases with denosumab therapy in patients with osteopenia or osteoporosis or. 2.3

BMD increased by 3% to 7% were seen in the lumbar spine (P. 001), and their impact on total hip BMD was about half of the results obtained in the lumbar spine. Markers of bone improved compared with placebo, similar to results achieved with alendronate (fosamaks). Consistent improvement in the IPC and decrease bone studies in patients with multiple myeloma and rheumatoid arthritis (RA) showed changes in the basic MRI assessment of erosion and decreased markers of bone metabolism, but no change in the joint evaluation of narrowing. RA disease activity does not improve, and not spare denosumab adding other drugs RA. 


Patient-oriented evidence of osteoporosis, spine and hip fracture rates are the most obvious is focused on patient outcomes. FREEDOM trial is a major patient-oriented 
 trial results with denosumab today. Researchers assigned 7,868 postmenopausal women, or denosumab 60 mg subcutaneously or placebo injections every 6 months for 36 months. All patients received calcium and vitamin D supplements. Patients with osteoporosis on bone scans of 24% with basic fractures of the spine. The primary end point was a new fracture of the spine. Secondary results of non-vertebral fractures and hip fracture. 


New vertebral fractures occurred in 2. 3% of patients receiving denosumab vs. 7. 2% of patients receiving placebo. This corresponds to 4. 9% absolute risk reduction (ARR) of denosumab or 68% reduction in relative risk (CMO). New hip fractures occurred in 0. 7% of patients treated with denosumab compared with 1. 2% of patients receiving placebo (ARR 0. 5%, RRR 40%, the number requiring treatment [NNT] 200). For every 200 patients treated with denosumab for 36 months, 1 patient will have a new hip fracture. NNT is a better measure of realistic effect than RRR. 


Table 1 shows the key fracture reduction data denosumab and bisphosphonates. Bisphosphonates are the basis for the prevention and treatment of osteoporosis, fractures, and they still can be characterized as first-line drugs for the treatment of osteoporosis. Studies have shown that androgen deprivation therapy, commonly used in treating prostate cancer, can cause increased markers of bone turnover, decreased bone mineral density and increased risk of fractures. Results of hormonal therapy ablation (HALT) trial found that denosumab was associated with increased BMD in the lumbar spine and total hip IPC. Incidence of new vertebral fractures was reduced from 3. 9% in the placebo group to 1. 5% denosumab. .