Osteoporosis: Reginster JY

Bergmann P, Body JJ, Boonen S, Boutsen Y, Devogelaer JP, Goemaere S, Kaufman JM, Reginster JY, Gangji V, Anonymous00023. · Laboratory of Clinical Chemistry, CHU Brugmann, Université Libre de Bruxelles, Bruxelles, Belgium. · Int J Clin Pract. · Pubmed #19125989 links to  free full text

Abstract: OBJECTIVES: To review the clinical value of bone turnover markers (BTM), to initiate and/or monitor anti-resorptive treatment for osteoporosis compared with bone mineral density (BMD) and to evaluate suitable BTM and changes in BTM levels for significance of treatment efficiency. METHODOLOGY: Consensus meeting generating guidelines for clinical practice after review and discussion of the randomised controlled trials or meta-analyses on the management of osteoporosis in postmenopausal women. RESULTS: Although the correlation between BMD and BTM is statistically significant, BTM cannot be used as predictive markers of BMD in an individual patient. Both are independent predictors of fracture risk, but BTM can only be used as an additional risk factor in the decision to treat. Current data do not support the use of BTM to select the optimal treatment. However, they can be used to monitor treatment efficiency before BMD changes can be evaluated. Early changes in BTM can be used to measure the clinical efficacy of an anti-resorptive treatment and to reinforce patient compliance. DISCUSSION: Determining a threshold of BTM reflecting an optimal long-term effect is not obvious. The objective should be the return to the premenopausal range and/or a decrease at least equal to the least significant change (30%). Preanalytical and analytical variability of BTM is an important limitation to their use. Serum C-terminal cross-linked telopeptide of type I collagen (CTX), procollagen 1 N terminal extension peptide and bone specific alkaline phosphatase (BSALP) appear to be the most suitable. Conclusion: Consensus regarding the use of BTM resulted in guidelines for clinical practice. BMD determines the indication to treat osteoporosis. BTM reflect treatment efficiency and can be used to motivate patients to persist with their medication.

Kanis JA, Burlet N, Cooper C, Delmas PD, Reginster JY, Borgstrom F, Rizzoli R, Anonymous00089. · WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield S10 2RX, UK. · Osteoporos Int. · Pubmed #18266020 links to  free full text

Abstract: SUMMARY: Guidance is provided in a European setting on the assessment and treatment of postmenopausal women with or at risk from osteoporosis. INTRODUCTION: The European Foundation for Osteoporosis and Bone disease (subsequently the International Osteoporosis Foundation) published guidelines for the diagnosis and management of osteoporosis in 1997. This manuscript updates these in a European setting. METHODS: The following areas are reviewed: the role of bone mineral density measurement for the diagnosis of osteoporosis and assessment of fracture risk; general and pharmacological management of osteoporosis; monitoring of treatment; assessment of fracture risk; case finding strategies; investigation of patients; health economics of treatment. RESULTS AND CONCLUSIONS: A platform is provided on which specific guidelines can be developed for national use.

Devogelaer JP, Goemaere S, Boonen S, Body JJ, Kaufman JM, Reginster JY, Rozenberg S, Boutsen Y. · Rheumatology Unit, Saint-Luc University Hospital, Université catholique de Louvain, Brussels, Belgium. · Osteoporos Int. · Pubmed #16217586 No free full text.

Abstract: Glucocorticoids (GCs) are frequently prescribed for various inflammatory and/or life-threatening conditions concerning many systems in the body. However, they can provoke many aftereffects, of which osteoporosis (OP) is one of the most crippling complications, with its host of fractures. The dramatic increase in bone fragility is mainly attributable to the GC-induced rapid bone loss in all skeletal compartments. We have reviewed the meta-analyses and randomized controlled studies reporting medical therapeutic interventions currently registered in Belgium for the management of GC-OP comparatively with a placebo. Based on this research, an expert meeting developed a consensus on the prevention and therapy of GC-OP. The pathophysiology of GC-OP is complex. Several factors, acting separately or synergistically, have been described. Their great number could help to understand the rapidity of bone loss and of bone fragility occurrence, indicating that a rapid therapeutic intervention should be implemented to avoid complications. All patients on GCs are threatened with OP, so the prevention and/or therapy of GC-OP should be considered not only for postmenopausal females, but also for osteopenic premenopausal females and for males put on a daily dose of at least 7.5 mg equivalent prednisolone that is expected to last at least 3 months. Non-pharmacological interventions, such as exercise and avoidance of tobacco and alcohol, should be recommended, even if their role is not definitely settled in GC-OP prevention. Supplemental calcium and vitamin D should be considered as the first-line therapy because of the decrease in intestinal calcium absorption provoked by GCs. They also could be considered either as isolated therapy in patients taking less than 7.5 mg prednisolone daily and/or for a predicted period shorter than 3 months or as adjuvant therapy to other more potent drugs. Hormone replacement therapy could be considered in young postmenopausal females on GC, such as in postmenopausal OP, or in men with low androgen levels. Calcitonin appears to have a protective effect on trabecular bone in GC-OP, just as in postmenopausal OP. There is an increasing body of evidence supporting the antifracture efficacy of bisphosphonates, notably alendronate and risedronate. Preventative and curative therapy of GC-OP should be maintained as long as the patient is on GC treatment and could be stopped after weaning from GC, because there is more than circumstantial evidence of some recovery of BMD when GCs are stopped. There is no indication in GC-OP for any combination of two antiresorptive agents (except for calcium and vitamin D) or for an antiresorptive and an anabolic agent. There is indeed no proof that the increased costs of combined treatments will translate into increased therapeutic efficacy.

Boonen S, Body JJ, Boutsen Y, Devogelaer JP, Goemaere S, Kaufman JM, Rozenberg S, Reginster JY. · Center for Metabolic Bone Diseases, Katholieke University Leuven, Leuven, Belgium. · Osteoporos Int. · Pubmed #15726235 No free full text.

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Kanis JA, Reginster JY. · No affiliation provided · Pol Arch Med Wewn. · Pubmed #19112812 links to  free full text

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Ormarsdottir S, Reginster JY, Abadie E. · No affiliation provided · Osteoporos Int. · Pubmed #18373059 No free full text.

Abstract: The current regulatory requirements offer accelerated assessment of innovative therapies in Europe. Future perspectives include the need for increased interaction between stakeholders in pharmaceutical development. Development of new, high quality, effective and safe medicines in Europe is the common goal of academia, pharmaceutical industry and regulatory authorities. To achieve this, it is important that regulatory requirements do not hinder innovation and vice versa, innovation cannot be allowed to proceed without concerns for public health. Interaction between stakeholders in pharmaceutical development is of the utmost importance. A dialogue has begun and in the future it will be the responsibility of all stakeholders to ensure continuous exchanges in an environment that is characterised by new scientific advances and global development programmes.

Reginster JY, Collette J, Neuprez A, Zegels B, Deroisy R, Bruyere O. · No affiliation provided · Bone. · Pubmed #18316258 No free full text.

Abstract: Most of the currently available anti-osteoporosis medications promptly and significantly influence the rate of bone turnover. Biochemical markers of bone turnover now provide a high sensitivity to change, allowing the detection of these bone turnover changes within a couple of weeks. Since the anti-fracture efficacy of inhibitors of bone resorption or stimulators of bone formation appears to be largely independent of baseline bone turnover, biochemical markers do not appear to play a significant role in the selection of one particular drug, for an individual patient. However, there are consistent data showing that short-term changes in biochemical markers of bone turnover may be significant predictors of future changes in bone mineral density or fracture reduction, hence suggesting that bone turnover markers play a significant role in the monitoring of anti-osteoporosis therapy.

Reginster JY. · No affiliation provided · Pol Arch Med Wewn. · Pubmed #17966592 links to  free full text

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Lekkerkerker F, Kanis JA, Alsayed N, Bouvenot G, Burlet N, Cahall D, Chines A, Delmas P, Dreiser RL, Ethgen D, Hughes N, Kaufman JM, Korte S, Kreutz G, Laslop A, Mitlak B, Rabenda V, Rizzoli R, Santora A, Schimmer R, Tsouderos Y, Viethel P, Reginster JY, Anonymous00251. · No affiliation provided · Osteoporos Int. · Pubmed #17585359 No free full text.

Abstract: SUMMARY: Adherence to anti-osteoporosis medications is currently low and is associated with poor anti-fracture efficacy. This manuscript reviews the potential design of clinical studies that aim to demonstrate improved adherence, with new chemical entities to be used in the management of osteoporosis. INTRODUCTION: Several medications have been unequivocally shown to decrease fracture rates in clinical trials. However, in real life settings, long-term persistence and compliance to anti-osteoporosis medication is poor, hence decreasing the clinical benefits for patients. METHODS: An extensive search of Medline from 1985 to 2006 retrieved all trials including the keywords osteoporosis, compliance, persistence or adherence followed by a critical appraisal of the data obtained through a consensus expert meeting. RESULTS: The impact of non-adherence on the clinical development of interventions is reviewed, so that clinicians, regulatory agencies and reimbursement agencies might be better informed of the problem, in order to stimulate the necessary research to document adherence. CONCLUSION: Adherence to therapy is a major problem in the treatment of osteoporosis. Both patients and medication factors are involved. Adherence studies are an important aspect of outcomes studies, but study methodologies are not well developed at the moment and should be improved. Performing adherence studies will be stimulated when registration authorities accept the result of these studies and include the relevant information in Sect. 5.1 of the summary of product characteristics. Reimbursement authorities might also consider such studies as important information for decisions on reimbursement.

Reginster JY, Abadie E, Delmas P, Rizzoli R, Dere W, der Auwera P, Avouac B, Brandi ML, Daifotis A, Diez-Perez A, Calvo G, Johnell O, Kaufman JM, Kreutz G, Laslop A, Lekkerkerker F, Mitlak B, Nilsson P, Orloff J, Smillie M, Taylor A, Tsouderos Y, Ethgen D, Flamion B. · No affiliation provided · Osteoporos Int. · Pubmed #16091835 No free full text.

Abstract: Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures.

Delmas PD, Khaltaev N, Arriagada M, Brandi ML, Cannata J, Lau E, Lederman R, Lorenc R, Minne H, Morales-Torres J, Morii H, Sambrook P, Torralba T, Zanchetta J, Reginster JY. · No affiliation provided · J Musculoskelet Neuronal Interact. · Pubmed #15951625 links to  free full text

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Reginster JY. · No affiliation provided · BMJ. · Pubmed #15831851 links to  free full text

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Reginster JY, Sarlet N, Lecart MP. · No affiliation provided · Osteoporos Int. · Pubmed #15599496 No free full text.

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Delmas PD, Rizzoli R, Cooper C, Reginster JY. · No affiliation provided · Osteoporos Int. · Pubmed #15565349 No free full text.

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Ben Sedrine W, Reginster JY. · No affiliation provided · Mayo Clin Proc. · Pubmed #12108598 links to  free full text

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Delmas PD, Calvo G, Boers M, Abadie E, Avouac B, Kahan A, Kaufman JM, Laslop A, Lekkerkerker JF, Nilsson P, Van Zwieten-Boot B, Kreutz G, Reginster JY, Anonymous00178. · INSERM Research Unit 403 and Claude Bernard University of Lyon, France. · Osteoporos Int. · Pubmed #11878450 No free full text.

Abstract: Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with the incidence of patients with new vertebral/nonvertebral fractures as the most usual primary endpoint. The use of a placebo in diseases where an active treatment is available has been a matter of debate following the update of the Declaration of Helsinki by the World Medical Association which questioned this trial design. Current regulatory recommendations within the European Union suggest that placebo-controlled trials are still the best option when assessing the efficacy and safety of new drugs intended for the treatment of postmenopausal osteoporosis. This suggestion seems to be in apparent contradiction with the current content of the Declaration of Helsinki. This paper addresses the ethics and feasibility of placebo-controlled trials in the treatment of postmenopausal osteoporosis, in the light of available therapeutic options, and discusses possible alternative approaches in those patients where placebo treatment could be deemed to be unethical. It is concluded that placebo-controlled trials remain the most efficient design to establish the efficacy and safety of a new agent for the treatment of postmenopausal osteoporosis. Such trials are feasible and ethically acceptable in patients with osteoporosis but without prevalent vertebral fractures. Conversely, in patients with prevalent vertebral fractures, placebo-controlled trials are ethically questionable and non-inferiority trials are more appropriate. A relative margin of non-inferiority of 20-30% is suggested, to be discussed on a case by case basis.

Neuprez A, Reginster JY. · Department of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium. · Best Pract Res Clin Endocrinol Metab. · Pubmed #19028361 No free full text.

Abstract: Women often consult for the first time after osteoporosis has already become established. Medications have therefore been developed which can stimulate bone formation, with the ultimate goal of restoring bone quantity and quality and reducing spinal and peripheral fractures to a greater extent than can be obtained with inhibitors of bone resorption. Peptides of the parathyroid hormone family, when given intermittently, increase the number and activity of osteoblasts, leading to an increase in bone mass and in an improvement in skeletal architecture. Teriparatide (1-34 parathyroid hormone, PTH) reduces vertebral and non-vertebral fractures at a dose of 20 microg/day given in subcutaneous daily injections. 1-84 PTH reduces vertebral fractures, but results on non-vertebral fractures are lacking. Strontium ranelate, suggested to uncouple bone formation from bone resorption, reduces vertebral, non-vertebral and hip fractures in osteoporotic patients aged >74 years. Reduction of a vertebral fracture has also been shown in osteopenic patients. Long-term (5-year) data are available on vertebral, non-vertebral, major non-vertebral and hip fractures in osteoporotic patients. Combination/sequential treatments using inhibitors of bone resorption and bone-forming agents have been assessed in a variety of regimens. Benefits from the use of bone-forming agents appear to be largely independent of previous treatment with inhibitors of bone resorption. After treatment with an anabolic agent, the use of anti-resorptive medications maintains the benefit of the former treatment. Concomitant use of an inhibitor of bone resorption and a stimulator of bone formation has not, so far, showed any additional benefit compared with each medication given alone.

Bruyere O, Brandi ML, Burlet N, Harvey N, Lyritis G, Minne H, Boonen S, Reginster JY, Rizzoli R, Akesson K. · Department of Public Health, Epidemiology & Health Economics, University of Liège, Liège, Belgium. · Curr Med Res Opin. · Pubmed #18759997 No free full text.

Abstract: BACKGROUND: Hip fracture creates a worldwide morbidity, mortality and economic burden. After surgery, many patients experience long-term disability or die as a consequence of the fracture. A fracture is a major risk factor for a subsequent fracture, which may occur within a short interval. METHODS: A literature search on post-fracture management of patients with hip fracture was performed on the Medline database. Key experts convened to develop a consensus document. FINDINGS: Management of hip-fracture patients to optimize outcome after hospital discharge requires several stages of care co-ordinated by a multidisciplinary team from before admission through to discharge. Further studies that specifically assess prevention and post-fracture management of hip fracture are needed, as only one study to date has assessed an osteoporosis medication in patients with a recent hip fracture. Proper nutrition is vital to assist bone repair and prevent further falls, particularly in malnourished patients. Vitamin D, calcium and protein supplementation is associated with an increase in hip BMD and reduction in falls. Rehabilitation is essential to improve functional disabilities and survival rates. Fall prevention and functional recovery strategies should include patient education and training to improve balance and increase muscle strength and mobility. Appropriate management can prevent further fractures and it is critical that high-risk patients are identified and treated. To foster this process, clinical pathways have been established to support orthopaedic surgeons. CONCLUSION: Although hip fracture is generally associated with poor outcomes, appropriate management can ensure optimal recovery and survival, and should be prioritized after a hip fracture to avoid deterioration of health and prevent subsequent fracture.

Reginster JY, Neuprez A, Bruyère O. · University of Liège, Public Health and Health Economics, Liège, Belgium. · Expert Opin Drug Metab Toxicol. · Pubmed #18624681 No free full text.

Abstract: BACKGROUND: Postmenopausal osteoporosis is a serious, chronic condition, for which nitrogen-containing bisphosphonates are now one of the treatments of choice. OBJECTIVE: To review the profile of ibandronate, a monthly oral (150 mg) or quarterly intravenous injection (3 mg) of bisphosphonate. METHODS: The literature search was limited to publications of ibandronate data. RESULTS/CONCLUSION: Ibandronate is rapidly absorbed and distributed in the bone; it is not metabolised and is excreted in urine. Clinical trial data have demonstrated the efficacy of ibandronate in reducing fracture risk, increasing bone mineral density and reducing bone turnover. These data are supported by recent meta-analyses and a large database study that have demonstrated antifracture efficacy with the ibandronate regimens used in clinical practice. Overall, ibandronate has generally been well tolerated. Therefore, ibandronate is a useful treatment for postmenopausal osteoporosis.

Goldhahn J, Scheele WH, Mitlak BH, Abadie E, Aspenberg P, Augat P, Brandi ML, Burlet N, Chines A, Delmas PD, Dupin-Roger I, Ethgen D, Hanson B, Hartl F, Kanis JA, Kewalramani R, Laslop A, Marsh D, Ormarsdottir S, Rizzoli R, Santora A, Schmidmaier G, Wagener M, Reginster JY. · Schulthess Clinic Zurich and Clinical Priority Program Fracture Fixation in Osteoporotic, Bone of AO Foundation, Davos, Switzerland. · Bone. · Pubmed #18544475 No free full text.

Abstract: Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate), they could provide an important adjunct to the treatment of fractures. However, widely accepted guidelines are important to encourage the conduct of studies to evaluate bioactive substances, drugs, and new agents that may promote fracture union and subsequent return to normal function. A consensus process was initiated to provide recommendations for the clinical evaluation of potential therapies to augment fracture repair in patients with meta- and diaphyseal fractures. Based on the characteristics of fracture healing and fixation, the following study objectives of a clinical study may be appropriate: a) acceleration of fracture union, b) acceleration of return to normal function and c) reduction of fracture healing complications. The intended goal(s) should determine subsequent study methodology. While an acceleration of return to normal function or a reduction of fracture healing complications in and of themselves may be sufficient primary study endpoints for a phase 3 pivotal study, acceleration of fracture union alone is not. Radiographic evaluation may either occur at multiple time points during the healing process with the aim of measuring the time taken to reach a defined status (e.g. cortical bridging of three cortices or disappearance of fracture lines), or could be obtained at a single pre-determined timepoint, were patients are expected to reach a common clinical milestone (i.e. pain free full weight-bearing in weight-bearing fracture cases). Validated Patient Reported Outcomes (PRO's) measures will need to support the return to normal function co-primary endpoints. If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device. The study design should be randomized, parallel, double-blind, and placebo-controlled, and all fracture subjects should receive a standardized method of fracture fixation, defined as Standard of Care.

Hiligsmann M, Ethgen O, Richy F, Reginster JY. · Department of Epidemiology, Public Health, and Health Economics, University of Liège, Avenue de l'hopital, Bat B23, 4000 Liege, Belgium. · Calcif Tissue Int. · Pubmed #18404243 No free full text.

Abstract: We reviewed studies that have estimated the impact of osteoporotic fracture on quality-adjusted life years (QALY) and to determine reference values for countries that would like to carry out cost-utility analyses but that do not have their own values. The computerized medical literature databases Medline and EMBASE were searched from January 1990 to December 2006. The search was carried out in two steps. The first step was to identify studies that related to quality of life in osteoporosis. As part of the second step, only the studies that translated quality of life into a utility value (one single value for health status ranging 0-1) and calculated a utility loss over a period of at least 1 year were selected. From the 152 studies identified in the first analysis, only 16 were retained after the second step. Ten studies investigated utility values for hip fractures, 11 for vertebral fractures, five for distal forearm fractures, and four for other osteoporotic fractures and fracture interactions. Utility values differed substantially between studies, partly due to the valuation technique used, the severity of fractures, and the sample size. This review suggests that there is no meaningful average value across different studies, different samples, different countries, or different instruments. Although we tried to determine the best available values, these values do not preclude the need for country-specific studies. Finally, we also make recommendations regarding the design and methodology for such studies.

Rizzoli R, Burlet N, Cahall D, Delmas PD, Eriksen EF, Felsenberg D, Grbic J, Jontell M, Landesberg R, Laslop A, Wollenhaupt M, Papapoulos S, Sezer O, Sprafka M, Reginster JY. · University Hospital and Faculty of Medicine, Geneva, Switzerland. · Bone. · Pubmed #18314405 No free full text.

Abstract: A potential side effect associated with bisphosphonates, a class of drugs used in the treatment of osteoporosis, Paget's disease and metastatic bone disease, is osteonecrosis of the jaw (ONJ). The incidence of ONJ in the general population is unknown; this rare condition also may occur in patients not receiving bisphosphonates. Case reports have discussed ONJ development in patients with multiple myeloma or metastatic breast cancer receiving bisphosphonates as palliation for bone metastases. These patients are also receiving chemotherapeutic agents that might impair the immune system and affect angiogenesis. The incidence or prevalence of ONJ in patients taking bisphosphonates for osteoporosis seems to be very rare. No causative relationship has been unequivocally demonstrated between ONJ and bisphosphonate therapy. A majority of ONJ occurs after tooth extraction. Furthermore, the underlying risk of developing ONJ may be increased in osteoporotic patients by comorbid diseases. Treatment for ONJ is generally conservative.

Goldhahn J, Mitlak B, Aspenberg P, Kanis JA, Rizzoli R, Reginster JY, Anonymous00378. · Department of Research, Schulthess Klinik, Lengghalde 2, Zurich 8008, Switzerland. · J Bone Joint Surg Am. · Pubmed #18292356 No free full text.

Abstract: Osteoporosis increases fracture risk, especially in metaphyseal bone. Fractures seriously impair function and quality of life and incur large direct and indirect costs. Although the prevention of fractures is certainly the option, a fast and uneventful healing process is optimal when fractures do occur. Many new therapeutic strategies have been developed to accelerate fracture-healing or to diminish the complication rate during the course of fracture-healing. However, widely accepted guidelines are needed to demonstrate the positive or negative interactions of bioactive substances, drugs, and other agents that are being used to promote fracture-healing. For each study design, the primary study goal should be indicated. Outcome variables should include both objective and subjective parameters. The guidelines should be harmonized between European and American regulatory authorities to ensure comparability of results of studies and to foster global harmonization of regulatory requirements.

Reginster JY. · Service de Santé Publique, Epidémiologie et Economie de la Santé, ULg, CHU Sart Tilman, Liège. · Rev Med Liege. · Pubmed #18217646 No free full text.

Abstract: Strontium ranelate, with its unique mode of action combining inhibition of bone resorption and stimulation of bone formation is characterized by a wide scatter of activity, both in terms of skeletal sites positively affected and of patients experiencing benefits of its administration. It is currently reimbursed, in Belgium, in osteoporotic patients aged 80 years and older. In this group, it is the only drug which has shown an extensive range of anti-fracture efficacy.

Reginster JY, Rabenda V. · WHO Collaborating Center for Public Health Aspects of Rheumatic Diseases, University of Liege, Liege, Belgium. · Clin Interv Aging. · Pubmed #18046918 links to  free full text

Abstract: The leading treatments for postmenopausal osteoporosis are the nitrogen-containing bisphosphonates, which are required long term for optimal benefit. Oral bisphosphonates have proven efficacy in postmenopausal osteoporosis in clinical trials, but in practice the therapeutic benefits are often compromised by patients' low adherence. Nonadherence to bisphosphonate therapy negatively impacts outcomes such as fracture rate; fractures are in turn associated with decreased quality of life. The most common reason cited by patients for their nonadherence is that the strict dosing instructions for bisphosphonates are difficult to follow. One aspect of bisphosphonate administration that can be changed is dosing frequency and several studies have evaluated patient preferences for different dosing schedules. Studies have shown a preference for a weekly bisphosphonate regimen versus daily dosing and it has been demonstrated that this preference for reduced dosing frequency impacts on adherence. Ibandronate is the first nitrogen-containing oral bisphosphonate for osteoporosis that can be administered in a monthly regimen and two robust clinical studies demonstrated a strong patient preference for this monthly regimen versus a weekly regimen. It is important that physicians consider patient preference when prescribing treatment for osteoporosis to ensure that the disease is effectively managed for the long-term benefit of the patient.