The active ingredient of the drug tren ace side effects alendronate sodium is a bisphosphonate that ipgibiruet mediated bone resorption by osteoclasts process, without exerting direct influence on the formation of new bone tissue. Preclinical studies show. alendronate that predominantly localized in the areas of active bone resorption. It inhibits the activity of osteoclasts, but does not affect the attraction and attachment of osteoclasts. During treatment with alendronate normal bone tissue is formed.
Treatment of postmenopausal osteoporosis
Osteoporosis is defined as a decrease in bone mineral density of the spine or hip 2.5 standard deviations compared with an average value in a population of healthy young people or a history of pathological fracture regardless .
Therapeutic equivalent drug dose of 70 mg, administered once a week (n = 519) and 10 mg alsndronata received once daily (n = 370) was shown in the annual .mnogotsentrovom study in women with osteoporosis nostmsnopauze. The mean increase in BMD of the lumbar vertebrae but compared to baseline at one year in the group receiving 70 mg once per week, and ) in the group treated with 10 mg once daily.The average increase , femoral tren ace side effects – 2.9% and 3.1% of the group treated with 70 mg once a week, and the group treated with 10 mg once a day, respectively .
both groups were also similar increase in tren ace side effects values of other skeletal sites. Effect alendronata bone mass and the fracture rate in postmenopausal women investigated in two studies, initial efficiency of identical design (n = 994) and also in the therapy study fractures .
In studies initial efficiency increase in the average bone mineral density at the reception alendronata 10 mg / day was 8.8% compared with placebo after three years, 5.9% and 7.8% for the spine, femoral neck and trochanter, respectively. Total body BMD also increased significantly. The number of patients with one or more vertebral fractures, reduced by 48% (3.2% but alendronata group compared with 6.2% in the placebo group) among patients treated with alendronate, compared with patients receiving placebo. During the two-year period of extension of these studies values of spine and trochanter continued to increase and tren ace side effects values of femoral neck and total body were unchanged.
FIT study consisted of two placebo-controlled studies using alendronate daily (5 mg daily for two years and 10 mg daily, for one or two years further):.
- FIT 2: The four-year study, in which 4432 patients were included with low bone mass but without the initial spinal fracture. In this study, the analysis of the subgroup of osteoporotic women (37% of the total population of the state of which corresponds to the above definition of osteoporosis), there was a significant difference in the incidence of hip fractures (1.0% in the group alepdronata compared with 2.2% in placebo, a decrease of 56%) and in the incidence of vertebral fracture ≥1 (2.9% compared with 5.8% to 50% reduction).
Results of laboratory tests
in the clinical trials of asymptomatic, mild tren ace side effects and transient decrease the concentration of calcium and phosphate in serum, respectively, were observed in approximately 18 and 10% of patients taking alendronate 10 mg / day, as compared to about 12%, and 3 patients received placebo. However, reducing the frequency of serum calcium concentrations to <8.0 mg / dl (2.0 mmol / L) and serum phosphate to ≤ 2,0 mg / dl (0.65 mmol / L) was similar in both treatment groups. Studies of the drug in children
The use of alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under 18 years of age. Results are insufficient to justify the use of alendronate sodium in children with osteogenesis imperfecta. Research application in men Although osteoporosis in men is not as common as in postmenopausal women, a significant proportion of fractures associated with osteoporosis are men. The prevalence of spinal deformities associated with osteoporosis, the same for men and women. Use of alendronate in doses of 10 mg 1 time per day in men for 2 years reduced urinary excretion of cross-linked N-telopeptides of type I collagen by about 60% and about kostespetsificheskoy alkaline phosphatase na 40%.
Similar results are observed whenper week for one year. Compared with placebo, the increase at the lumbar spine of 5.3% at the femoral neck -2.6%, in the greater trochanter – 3.1%.
When alendronate 10 mg per day for men was a decrease in the incidence of vertebral fractures, which was 0.8% compared with 7.1% for placebo. Also, a decrease of magnitude reduction in growth, which was 0.6 mm with alendronate compared to 2.4 mm in the placebo. In applying 70 mg 1 time per week for 1 year there is an increase in tren ace side effects at the lumbar spine, 2.8% at the femoral neck – 1.9% in the femoral – 2.0% pa, while in others parts of the body – by 1.2% as compared to placebo.