OBJECTIVES: The aim of the study was the evaluation of the effect of alendronate in the treatment of postmenopausal osteoporosis on subjective criteria and on bone mineral density after two years. MATERIAL AND METHODS: The authors collected data from 44 women by questionaire and analysed the data from DEXA examination. The patients were given Fosamax 10 mg and calcium 500 mg per day in the years 2001-2002. RESULTS: The compliance of alendronate was good in 42 women (95.5%). 15 patients were very satisfied with the treatment, 22 were satisfied and 5 patients claimed no improvement at the end of the study. A positive effect of the treatment was seen in 37 patients (88.1%). 21 patients claimed to have no pain and 15 patients suffered mild intermitent pain at the end of the study. 24 patients used no analgetics and 9 patients used them irregularly. 11 patients claimed to have normal activity and 22 patients had mildly diminished activity in daily life. The authors encountered no symptomatic vertebral or nonvertebral fracture during the study. The mean BMD in the lumbar spine improved in T score by 0.38 SD after one year and 0.35 SD after the second year. The mean BMD has improved in the neck region in T score by 0.21 SD after the first year and 0.21 SD after the second year. The mean BMD in lumbar spine has improved in Z score by 0.31 SD after one year and 0.02 SD after the second year. The mean BMD in the neck region has improved in Z score by 0.31 SD after the first year and 0.16 SD after the second year. The mean change of bone mineral density in lumbar spine was +4.17% after the first years and +4.19% after the second year. The mean change of BMD in the femoral neck region was +4.46% after the first years and + 3.71% after the second year. According to student t-test all the data of increased BMD were statisticaly significant at the 5% level of the significance (p < 0.05). CONCLUSION: Alendronate therapy significantly reduced the pain and the need for analgesics. It improved the daily activity and mobility of the spine in the patients with postmenopausal osteoporosis. It resulted in a positive change of BMD in vertebral region of +8.36% and +8.17% in the femoral neck region after two years. The fracture risk in vertebral region was diminished by 31% and in the femoral neck region by 38% at the end of the study. (Tab. 11, Ref. 14.).

• MeSH
• alendronát terapeutické užití   MeSH
• kostní denzita MeSH
• lidé středního věku MeSH
• lidé MeSH
• postmenopauzální osteoporóza diagnóza   farmakoterapie   MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• alendronát MeSH

Denosumab is a monoclonal antibody used to reduce risk of fractures in osteoporosis. ROSALIA was a multicenter, double-blind, randomized, integrated phase I/phase III study comparing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of proposed biosimilar denosumab GP2411 with reference denosumab (REF-DMAb) (Prolia®; Amgen). Postmenopausal women with osteoporosis were randomized 1:1 to 2 60-mg doses of GP2411 or REF-DMAb, one at study start and one at week 26. At week 52, the REF-DMAb group was re-randomized 1:1 to a third dose of REF-DMAb or switch to GP2411. The primary efficacy endpoint was percentage change from baseline (%CfB) in LS-BMD at week 52. Secondary efficacy endpoints were %CfB in LS-BMD, FN-BMD, and TH-BMD at weeks 26 and 78 (and week 52 for FN-BMD and TH-BMD). Primary PK and PD endpoints were the area under the serum concentration-time curve extrapolated to infinity and maximum drug serum concentration at week 26, and the area under the effect-time curve of the %CfB in serum CTX at week 26. Secondary PK and PD endpoints included drug serum concentrations and %CfB in serum CTX and P1NP during the study period. Similar efficacy was demonstrated at week 52, with 95% CIs of the difference in %CfB in LS-BMD between treatment groups fully contained within prespecified equivalence margins. Similarity in PK and PD was demonstrated at week 26. Immunogenicity was similar between groups and was not impacted by treatment switch. The rate of new vertebral fractures was comparable. Treatment-emergent adverse events were comparable between groups (63.6% [GP2411/GP2411]; 76.0% [REF-DMAb/REF-DMAb]; 76.6% [REF-DMAb/GP2411]). In conclusion, ROSALIA showed similar efficacy, PK and PD, and comparable safety and immunogenicity of GP2411 to REF-DMAb in postmenopausal osteoporosis.

Denosumab is a biologic treatment that stops bone breakdown. This clinical trial evaluated how similar GP2411 (a denosumab biosimilar in development) is compared with European-approved reference denosumab in women with post-menopausal osteoporosis. Biosimilars are highly similar to the original treatment (‘reference denosumab’) and may have a lower price. 263 patients were randomly assigned to receive GP2411 and 264 to reference denosumab. Treatment was given at the study beginning, at Week 26 and at Week 52. 124 patients were re-assigned at Week 52 to test the effect of changing from reference denosumab to GP2411. The study showed similarity in how the body interacts with the treatments, what effects the treatment has (both measured over 26 weeks), and bone mineral density (measured over 78 weeks). Antibody responses to GP2411 were detected in similar proportions of patients on each treatment. Reported adverse events were similar between treatments before Week 52, and from Week 52 to 78, and <5% of patients experienced serious adverse events. A change of treatment from reference denosumab to GP2411 did not affect outcomes. These results showed similarity between GP2411 and reference denosumab in this population. In future, GP2411 may enable more patients to benefit from denosumab.

• Klíčová slova
• bone modeling and remodeling: biochemical markers of bone turnover, clinical trials, diseases and disorders of/related to bone: osteoporosis,
• MeSH
• biosimilární léčivé přípravky * škodlivé účinky   MeSH
• denosumab škodlivé účinky   MeSH
• dvojitá slepá metoda MeSH
• inhibitory kostní resorpce * terapeutické užití   MeSH
• kostní denzita MeSH
• lidé MeSH
• osteoporóza * farmakoterapie   MeSH
• postmenopauzální osteoporóza * farmakoterapie   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• klinické zkoušky, fáze I MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• biosimilární léčivé přípravky * MeSH
• denosumab MeSH
• inhibitory kostní resorpce * MeSH

In the treatment of osteoporosis, the aim of the antiresorptive therapy is to restore bone density by decreasing bone remodeling. The process of bone remodeling plays a role in plasma calcium homeostasis and serves to modify bone architecture in order to meet changing mechanical needs, to maintain osteocyte viability, and to repair microdamage in bone matrix. Estrogen deficiency results in a number of detrimental effects on bone, including suppression of osteocyte survival as well as impairment of osteoblast response to mechanical stimuli and repair of ageing bone. In this review, effects of available antiresorptive therapies on endocrine regulations of bone metabolism in postmenopausal osteoporosis are compared. The aim of antiresorptive treatment is to ensure adequate bone remodeling, reparation of microdamage of bone, and increased bone strength. Ideally, this effect should be maintained long-term. Several agents are approved for the treatment of osteoporosis. Calcitonin transiently inhibits osteoclast activity without decreasing osteoblast collagen synthesis. Aminobisphosphonates decrease bone remodeling by decreasing osteoclast activity and by inducing osteoclast apoptosis. This allows more time for secondary mineralization to proceed to completion in the existing bone tissue mass, so increasing the mechanical resistance of bone to loading. Estrogens and raloxifene (a selective estrogen receptor modulator that acts as an estrogen agonist in bone) suppress bone remodeling to the premenopausal range, maintaining the function of osteoblasts and osteocytes. In the placebo-controlled osteoporosis treatment trials, all the above treatments reduced the risk of fractures. Raloxifene therapy was also associated with a favorable or neutral effect in the cardiovascular system, and a reduced incidence of breast cancer. Selection of appropriate drug for treatment of postmenopausal osteoporosis should take into account the long-term effect of the antiresorptive agent on bone. Moreover, the effects on other tissues ++should also be considered, and this encompasses both safety concerns, as well as the potentially beneficial effects on other tissues. Further investigation is needed to evaluate the different modes of action of these agents, and their long-term effects on bone and other tissues.

• MeSH
• alendronát farmakologie   terapeutické užití   MeSH
• bisfosfonáty farmakologie   terapeutické užití   MeSH
• estrogenní substituční terapie MeSH
• estrogeny fyziologie   MeSH
• kalcitonin farmakologie   terapeutické užití   MeSH
• kostní denzita MeSH
• lidé MeSH
• postmenopauzální osteoporóza farmakoterapie   MeSH
• raloxifen hydrochlorid farmakologie   terapeutické užití   MeSH
• remodelace kosti účinky léků   MeSH
• resorpce kosti farmakoterapie   MeSH
• selektivní modulátory estrogenních receptorů farmakologie   terapeutické užití   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• alendronát MeSH
• bisfosfonáty MeSH
• estrogeny MeSH
• kalcitonin MeSH
• raloxifen hydrochlorid MeSH
• selektivní modulátory estrogenních receptorů MeSH

The 2-year, randomized, double-blind, active-controlled fracture endpoint VERO study included postmenopausal women with established osteoporosis, who had at least 2 moderate or 1 severe baseline vertebral fractures (VFx), and bone mineral density (BMD) T-score ≤-1.5. Patients were treated with either s.c. daily teriparatide 20 μg or oral weekly risedronate 35 mg. As previously reported, the risk of new VFx and clinical fractures (a composite of clinical VFx and nonvertebral fragility fractures [NVFFx]) was statistically significantly reduced with teriparatide compared with risedronate. Here we present the prospectively planned subgroup analyses of fracture data across subgroups, which were predefined by the following baseline characteristics: age, number and severity of prevalent VFx, prevalent nonvertebral fractures (NVFx), glucocorticoid use, prior osteoporosis drugs, recent bisphosphonate use, clinical VFx in the year before study entry, and baseline BMD. Heterogeneity of the treatment effect on the primary endpoint (new VFx), and the four key secondary endpoints (including clinical fractures and NVFFx) were investigated by logistic and Cox proportional hazards regression models. A total of 1360 women were randomized and treated (680 per group). Mean age was 72.1 years, mean (SD) number of prevalent VFx was 2.7 (2.1), 55.4% had a BMD T-score <-2.5, 36.5% had a recent clinical VFx, 28.3% had a prior major NVFx, 43.2% were osteoporosis drug-naïve, 39.3% were recent bisphosphonate users, and 9.3% were taking glucocorticoids at a prednisone-equivalent dose of >5 mg/d. For most fracture endpoints, the risk reduction of teriparatide versus risedronate did not significantly differ in any of the subgroups analyzed (treatment-by-subgroup interaction p > 0.1), with most subgroups mirroring results from the total study population. In conclusion, in postmenopausal women with severe osteoporosis, the antifracture efficacy of teriparatide compared with risedronate was consistent in a wide range of patient settings, including treatment-naïve and previously treated patients. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.

• Klíčová slova
• BISPHOSPHONATES, POSTMENOPAUSAL OSTEOPOROSIS, SUBGROUP ANALYSIS, TERIPARATIDE, VERTEBRAL FRACTURES,
• MeSH
• dvojitá slepá metoda MeSH
• fraktury páteře farmakoterapie   metabolismus   patologie   MeSH
• kyselina risedronová aplikace a dávkování   MeSH
• lidé MeSH
• osteoporóza farmakoterapie   metabolismus   patologie   MeSH
• postmenopauza * MeSH
• rizikové faktory MeSH
• senioři MeSH
• teriparatid aplikace a dávkování   MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• kyselina risedronová MeSH
• teriparatid MeSH

PURPOSE: This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16. METHODS: 457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period. RESULTS: Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16. CONCLUSION: Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.

• Klíčová slova
• Biosimilar, Bone mineral density, Clinical trials, Denosumab, Postmenopausal osteoporosis, SB16,
• MeSH
• denosumab * terapeutické užití   farmakokinetika   škodlivé účinky   MeSH
• humanizované monoklonální protilátky * terapeutické užití   farmakokinetika   škodlivé účinky   MeSH
• inhibitory kostní resorpce * terapeutické užití   farmakokinetika   škodlivé účinky   MeSH
• kostní denzita účinky léků   MeSH
• lidé středního věku MeSH
• lidé MeSH
• postmenopauzální osteoporóza * farmakoterapie   MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• denosumab * MeSH
• humanizované monoklonální protilátky * MeSH
• inhibitory kostní resorpce * MeSH

Prospective, controlled clinical trials in postmenopausal osteoporosis typically compare effects of an active drug with placebo in addition to vitamin D and calcium supplementation in both treatment arms. While clinical benefits are documented, the effect of this supplementation in the placebo arm and in clinical practice on bone material composition properties is unknown. The purpose of the present study was to evaluate these bone quality indices (specifically mineral/matrix, nanoporosity, glycosaminoglycan content, mineral maturity/crystallinity, and pyridinoline content) in patients that either received long-term vitamin D (400-1200IU) and calcium (1.0-1.5g) supplementation, or did not. We have analyzed by Raman microspectroscopy the bone forming trabecular surfaces of iliac crest in pre-treatment samples of a teriparatide study and the endpoint biopsies of the control arm obtained from the HORIZON trial. In general, the mineral/matrix ratio and the glycosaminoglycan (GAG) content was higher while nanoporosity, (a surrogate for tissue water content), the mineral maturity/crystallinity (MMC) and the pyridinoline (Pyd) content was lower in patients without long-term supplementation. Moreover, all indices were significantly dependent on tissue age. In conclusion, vitamin D and calcium supplementation is associated with altered mineral and organic matrix properties.

• Klíčová slova
• Bone quality, Calcium, Postmenopausal osteoporosis, Raman spectroscopy, Vitamin D,
• MeSH
• aminokyseliny metabolismus   MeSH
• analýza rozptylu MeSH
• fyziologická kalcifikace účinky léků   MeSH
• glykosaminoglykany metabolismus   MeSH
• kostní matrix účinky léků   metabolismus   MeSH
• lidé MeSH
• nanočástice chemie   MeSH
• poréznost MeSH
• postmenopauzální osteoporóza farmakoterapie   patofyziologie   MeSH
• potravní doplňky * MeSH
• Ramanova spektroskopie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• vápník farmakologie   terapeutické užití   MeSH
• vitamin D farmakologie   terapeutické užití   MeSH
• Check Tag
• lidé MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Názvy látek
• aminokyseliny MeSH
• glykosaminoglykany MeSH
• pyridinoline MeSH Prohlížeč
• vápník MeSH
• vitamin D MeSH

INTRODUCTION: Osteoporosis is characterized by low bone mineral density (BMD) and an increased risk of fracture. In randomized controlled trials, denosumab has been shown to significantly reduce the fracture risk in women with osteoporosis. However, little is known about the real-world management of women who are prescribed denosumab. METHODS: This multicenter, prospective, observational real-world study in the Czech Republic and Slovakia evaluated the baseline characteristics and clinical management of women with postmenopausal osteoporosis prescribed denosumab for 24 months. RESULTS: A total of 600 women were included (300 in each country). In the Czech Republic and Slovakia, respectively, mean age at enrollment was 69.0 and 64.3 years, 67.7% and 30.0% of patients had a previous osteoporotic fracture, and 85.0% and 48.7% had previously received osteoporosis medication. In both countries, 'low BMD T score' and 'a history of osteoporotic fracture' were the main reasons for prescribing denosumab. Most patients received all four post-baseline denosumab injections (Czech Republic, 82.0%; Slovakia, 81.0%), and more than 98% of patients in both countries received all injections at the prescribing center. At 24 months, most patients experienced an increase in BMD T score for the lumbar spine, total hip, or femoral neck (Czech Republic, 69.7-91.7%; Slovakia, 67.1-92.9%). Adverse drug reactions were consistent with the known safety profile of denosumab. CONCLUSION: Baseline characteristics of patients receiving denosumab in the Czech Republic and Slovakia reflect the reimbursement criteria for this agent in each country. The findings of our study in patients who are at high risk for fracture are consistent with the growing body of evidence demonstrating the effectiveness of denosumab in real-world clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01652690. FUNDING: Amgen Inc.

• Klíčová slova
• Clinical practice, Czech Republic, Denosumab, Osteoporosis, Postmenopausal, Slovakia,
• MeSH
• denosumab * aplikace a dávkování   škodlivé účinky   MeSH
• hodnocení rizik MeSH
• hodnocení výsledků zdravotní péče MeSH
• inhibitory kostní resorpce aplikace a dávkování   škodlivé účinky   MeSH
• kostní denzita účinky léků   MeSH
• lidé středního věku MeSH
• lidé MeSH
• osteoporotické fraktury * epidemiologie   etiologie   prevence a kontrola   MeSH
• postmenopauzální osteoporóza * komplikace   farmakoterapie   epidemiologie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• služby preventivní péče metody   statistika a číselné údaje   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika epidemiologie   MeSH
• Slovenská republika epidemiologie   MeSH
• Názvy látek
• denosumab * MeSH
• inhibitory kostní resorpce MeSH

Postmenopausal osteoporosis (PMOP) therapies are frequently evaluated by bone mineral density (BMD) gains against patients receiving placebo (calcium and vitamin D supplementation, a mild bone turnover-suppressing intervention), which is not equivalent to either healthy or treatment-naive PMOP. The aim of the present observational study was to assess the effects of TPTD treatment in PMOP (20 μg, once daily) at 6 (TPTD 6m; n = 28, age 65 ± 7.3 years), and 24 (TPTD 24m; n = 32, age 67.4 ± 6.15 years) months on bone quality indices at actively forming trabecular surfaces (with fluorescent double labels). Data from the TPTD-treated PMOP patients were compared with those in healthy adult premenopausal women (HC; n = 62, age 40.5 ± 10.6 years), and PMOP receiving placebo (PMOP-PLC; n = 94, age 70.6 ± 4.5 years). Iliac crest biopsies were analyzed by Raman microspectroscopy at three distinct tissue ages: mid-distance between the second label and the bone surface, mid-distance between the two labels, and 1 μm behind the first label. Mineral to matrix ratio (MM), mineral maturity/crystallinity (MMC), tissue water (TW), glycosaminoglycan (GAGs), and pyridinoline (Pyd) content were determined. Outcomes were compared by ANCOVA with subject age and tissue age as covariates, and health status as a fixed factor, followed by Sidak's post-hoc testing (significance assigned to p < 0.05). Both TPTD groups increased MM compared to PMOP-PLC. While TPTD 6m had values similar to HC, TPTD 24m had higher values compared to either HC or TPTD 6m. Both TPTD groups had lower MMC values compared to PMOP-PLC and similar to HC. TPTD 6m patients had higher TW content compared to HC, while TPTD 24m had values similar to HC and lower than either PMOP-PLC or TPTD 6m. Both TPTD groups had lower GAG content compared to HC group, while TPTD 6m had higher values compared to PMOP-PLC. Finally, TPTD 6m patients had higher Pyd content compared to HC and lower compared to PMOP-PLC, while TPTD 24m had lower values compared to PMOP-PLC and TPTD 6m, and similar to HC group. The results of the present study indicate that effects of TPTD on forming trabecular bone quality indices depend on treatment duration. At the recommended length of 24 m, TPTD restores bone mineral and organic matrix quality indices (MMC, TW, Pyd content) to premenopausal healthy (HC) levels.

• Klíčová slova
• Bone formation, Bone quality, Human iliac crest biopsies, Postmenopausal osteoporosis, Raman spectroscopy, Teriparatide,
• MeSH
• dospělí MeSH
• inhibitory kostní resorpce * farmakologie   terapeutické užití   MeSH
• kostní denzita MeSH
• lidé středního věku MeSH
• lidé MeSH
• os ilium patologie   MeSH
• postmenopauzální osteoporóza * farmakoterapie   patologie   MeSH
• senioři MeSH
• teriparatid farmakologie   terapeutické užití   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• Názvy látek
• inhibitory kostní resorpce * MeSH
• teriparatid MeSH

CONTEXT: SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia). OBJECTIVE: This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959). DESIGN: The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between -2.5 and -4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12. METHODS: The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12. RESULTS: The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, -0.25 to 0.91) in the full analysis set and 0.39% (95% CI, -0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups. CONCLUSION: The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.

• Klíčová slova
• clinical trials, menopause, metabolic bone disease, osteoporosis,
• MeSH
• bederní obratle účinky léků   diagnostické zobrazování   MeSH
• biosimilární léčivé přípravky * terapeutické užití   farmakokinetika   aplikace a dávkování   škodlivé účinky   MeSH
• denosumab * terapeutické užití   farmakokinetika   škodlivé účinky   aplikace a dávkování   MeSH
• dvojitá slepá metoda MeSH
• inhibitory kostní resorpce * terapeutické užití   farmakokinetika   aplikace a dávkování   škodlivé účinky   MeSH
• kostní denzita účinky léků   MeSH
• lidé středního věku MeSH
• lidé MeSH
• postmenopauzální osteoporóza * farmakoterapie   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• biosimilární léčivé přípravky * MeSH
• denosumab * MeSH
• inhibitory kostní resorpce * MeSH

OBJECTIVES: The aim of the study was the evaluation of the rs1107946 polymorphism of the COLIA1 gene impact on bone mineral density and fracture risk in Slovak postmenopausal women. METHODS: One hundred and twenty-seven postmenopausal Slovak women with a diagnosis of osteopenia/osteoporosis were genotyped for rs1107946 polymorphism of the COLIA1 gene. Clinical and anthropometric data were obtained. DNA isolation was performed using a standard protocol. Genetic analyses of the rs1107946 polymorphism of the COLIA1 gene were performed by the TaqMan SNP genotyping assays. RESULTS: The study confirmed a statistically significant relationship using an association analysis between the rs1107946 polymorphism of the COLIA1 gene genotypes and body weight of the Slovak postmenopausal women with osteopenia/osteoporosis (p = 0.03). The study revealed a significant association of the risk T allele of the rs1107946 polymorphism of the COLIA1 gene with osteoporotic fractures (p = 0.038). The odds ratio confirmed 2.060 times higher risk of osteoporotic fractures in Slovak postmenopausal women with the presence of risk T allele of the rs1107946 COLIA1 gene polymorphism (OR = 2.060; 95% CI: 1.024-4.144). CONCLUSION: The results of this study revealed an association of T allele of the rs1107946 COLIA1 gene polymorphism with osteoporotic fractures in Slovak postmenopausal women with osteopenia/osteoporosis and suggest that the rs1107946 polymorphism of the COLIA1 gene may be a molecular biomarker usable in the management of osteoporosis.

• Klíčová slova
• COLIA1 gene - rs1107946 polymorphism, fracture risk, osteoporosis, postmenopausal women,
• MeSH
• genotyp MeSH
• kostní denzita genetika   MeSH
• lidé MeSH
• osteoporotické fraktury * komplikace   MeSH
• osteoporóza * komplikace   genetika   MeSH
• polymorfismus genetický MeSH
• postmenopauza MeSH
• postmenopauzální osteoporóza * genetika   komplikace   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Slovenská republika epidemiologie   MeSH