Monthly or weekly bisphosphonate? Evaluation of satisfaction in patients with postmenopausal osteoporosis using OPSAT-Q questionnaire during the BOOSTER study in Croatia.

A prospective, open-labelled, multicentre 6-month study was designed to assess three categories that have high impact on Health-Related Quality of Life (HR-QoL). These categories were: satisfaction, preference and drug tolerability in postmenopausal patients with osteoporosis in Croatia, at first treated with weekly oral bisphosphonates, followed by monthly oral ibandronate. Three hundred eighty-five postmenopausal women who were treated with one of the weekly bisphosphonates for at least 6 months were included into the study and after they had signed written informed consent, the therapy was changed to monthly ibandronate. Satisfaction with the treatment was assessed with the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q). Patients completed OPSAT-Q at the baseline visit before the change of therapy (visit 1) and 6 months after the change of therapy (visit 2). Following 6 months ibandronate therapy, the values in all four domains of the OPSAT-Q (convenience, confidence with daily activities, overall satisfaction, side effects) as well as in the Composite Satisfaction Score were higher in visit 2 (p < 0.001). Values in subjects enrolled into the patient assistance programme did not differ significantly from the values in subjects that were not (p = 0.399) except for the domain convenience (p = 0.026). This study demonstrates significantly higher satisfaction in patients who switched from the weekly bisphosphonate therapy regimen to monthly ibandronate in all observed aspects of treatment. Patients expressed preference for monthly bisphosphonate (ibandronate) in comparison with weekly bisphosphonates and found it to be a more convenient method of treatment. At the time of study, however, it was not known that the anti-fracture effect of ibandronate was smaller for hip fractures than with other bisphosphonates.

Health-related quality of life among patients with postmenopausal osteoporosis treated with weekly and monthly bisphosphonates.

OBJECTIVE: The present study was designed to assess the effect of monthly ibandronate on health-related quality of life (HR-QoL) in patients with postmenopausal osteoporosis previously treated with weekly bisphosphonates. METHODS: HR-QoL was assessed by Euroqol (EQ-5D) and Osteoporosis Targeted Quality of Life (OPTQoL) questionnaires. RESULTS: The EQ-5D questionnaire showed significant improvement associated with ibandronate treatment, occurring in mobility (p < 0.01), usual activity (p < 0.01), pain/discomfort (p < 0.05), and anxiety/depression (p < 0.05). In addition, ibandronate treatment considerably improved patients' perceived health on a visual analog scale (p < 0.001). For the OPTQoL questionnaire, patients reported less physical difficulty (p < 0.001), fewer adaptations in their lives (p < 0.001), and less fear (p < 0.001) with ibandronate than with weekly bisphosphonates. CONCLUSION: The study demonstrated that patients who were transferred from weekly bisphosphonates to a monthly ibandronate experienced improved HR-QoL.

[Prevention of thromboembolism and survival after trauma]. / Tromboembolijska profilasksa i prezivljenje nakon ozljede.

AIM: Thromboembolism (TE) is a well-known and potentially fatal complication after injury and orthopedic surgery. Thromboembolic prophylaxis is generally recognized as a factor of significant interest concerning posttraumatic comorbidity and mortality. In this context, the aim of the study was to analyze hospital mortality 24 hours after injury, and to assess the proportion of fatal pulmonary embolism in overall hospital mortality. Finally, the purpose of the study was to explore the possible correlation between different prophylactic approaches and hospital mortality. METHODS: A retrospective-prospective study was conducted at the University Hospital of Traumatology, Zagreb, over a 14-year period (1988-2001). The study was based on documented clinical and autopsy findings and comprised all trauma patients admitted for hospital treatment. The overall and thromboembolic mortality were analyzed for each individual year during the study period. These two variables were compared and expressed as a proportion for each year. Further analysis included comparison of the data obtained between years and sequences of years. The modes of TE prophylaxis in various periods were analyzed as well. Differences in the mortality rates were tested for statistical significance. Results obtained for each period of time were compared and expressed as a function of different approaches to thromboembolic prevention. RESULTS: Results obtained in the study demonstrated a clear tendency towards the decrease in the overall mortality as well as in the mortality due to fatal pulmonary embolism. Mortality rates showed significant differences during the study period. The most prominent difference was found between the first and final year of investigation. In 1988, the overall mortality was 3.78% and TE mortality 2.05%, whereas in 2001 the respective rates were 1.17% and 0.3% (p < 0.001). A continuous significant mortality decrease in trauma patients was recorded for some years and sequences of years (p < 0.05). The proportion of TE fatality in the overall mortality was > 50% in 1988 and about 25% in 2001. Our results demonstrated a 70% reduction in the overall mortality and even 85% reduction in the fatal TE rate. Finally, a significant reduction of TE fatality by 55% independently of overall mortality reduction was observed. The decreasing mortality rate correlated with different approaches to TE prophylaxis during the 14-year-period. DISCUSSION: Thromboembolism accounted for a considerable proportion of the mortality rate in trauma patients during the study period. The observed dynamics, expressed as a 70% reduction in the overall hospital mortality and an 85% decrease in the fatal PE rate reflected significant improvement in trauma treatment. Further, independently of the overall mortality, TE mortality was reduced by more than 55%, which was obviously related to the changing approaches to TE prevention. At the beginning, physical methods of prophylaxis prevailed. Prophylactic anticoagulation with heparin was started sporadically around 1991 and have been enhanced over time. In 1995, it was included in the routine treatment of specific patient categories. Since 1998, low molecular weight heparin has become the gold standard in TE prophylaxis, with more prominent application in severe multiple injuries. With the recent approach, we have managed to overcome the controversies in the treatment of severe injuries, primarily concerning bleeding and TE, and achieved considerable improvement. CONCLUSION: A significant reduction in the mortality, especially due to fatal pulmonary embolism after injury, was clearly demonstrated. This could be explained by improvements in the management of trauma and organized TE prevention.

[Study of friction and loosening in hip endoprostheses]. / Ispitivanje trenja i rasklimavanja endoproteze kuka.

AIM: Like any other operative procedure, the implantation of hip prosthesis is associated with certain complications, which diminishes the value and purpose of such a procedure. One of the complications in artificial hip implantation is loosening of the alloplastic material. Therefore, the aim of this study was to examine the effect of lubrication on the torsional moment and its role in the loosening of the femoral component, using an experimental mechanical model. The following hypothesis was tested: the magnitude of torsional loading in the "bone-endoprosthesis-bone cement system" is similar to any other known loading. METHODS: The testing device was constructed with the possibility of simulation of positions similar to original performances in the implanted hip prosthesis. It refers primarily to the possibilities of achieving definite forces and velocities. The intention was to point quantitatively to the role of friction moment between the acetabular and femoral endoprosthesis part. Trials were conducted by combining 7 types of loading and 4 kinds of lubrication: dry, water, plasma, and light oil. The testing joint (Ring's prosthesis) was connected through tensometric measuring shaft upon the working forepart oscillating mechanism. Graded by the changeable static loading by means of the pendulum and via lever mechanism the testing joint was loaded by force from 610 to 7137 N. As the cause of friction resistance in the moving joint, torque deformaties of the measuring shaft occurred. The testing joint enabled oscillating movement using a four-part mechanism. In this way, it was possible to define not only the maximum values of the frictional moment (or the coefficient of friction) during one movement cycle but also to examine its relation to the kind of lubrication. Change in the measuring torsional moment were computer recorded. Before each trial, the gauging of the complete outfit was performed. Thereafter, cleaning of the frictional surfaces of the whole outfit was done. RESULTS: The results obtained in combination with lubrication showed a slight increase in the values of the frictional moment. With dry lubrication and greater loading, an extremely progressive gradient of change was recorded. The course of change in the coefficient of friction was essentially different from the course of change in the frictional moment. It was noted particularly during trials with lubrication. In trials without lubrication, a constant increase of loading (force) resulted in a progressive increase in the coefficient of friction, similar to the friction moment. Such a character of the friction moment increase in the observed loading field was explained by the presence of boundary friction in cases with lubrication and by dry friction in cases without lubrication. In dry friction, scratching occurs relatively early, at a loading of F = 1854 N. It occurs with substances of approximately the same hardness like Ring's prosthesis, where the acetabular and femoral prosthesis parts are of metal characteristics. CONCLUSION: The increase in the frictional moment within the observed loading range can be explained by the presence of bordering friction in cases with lubrication, and of dry friction in cases without lubrication. Contrary to this, dry friction relatively early leads to "scratching", especially when sparing materials of similar hardness are combined.