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Silvano Adami - One of the best experts on this subject based on the ideXlab platform.
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Osteoporosis Treatment why ibandronic acid
Expert Opinion on Pharmacotherapy, 2013Co-Authors: Maurizio Rossini, Giovanni Orsolini, Silvano Adami, Vidya Satheesn Kunnathully, Davide GattiAbstract:Introduction: In this article, we have summarized the specific evidence on ibandronic acid (or ibandronate) efficacy, tolerability, and feasibility acquired from trials and clinical use. Areas covered: This critical review focuses on evidence from randomized controlled clinical trials, meta-analyses, surrogate markers, bridging trials, long-term extension studies, observational studies, clinical experiences in Osteoporosis in addition to postmenopausal Treatment adherence in clinical practice, and safety profile of ibandronic acid. Expert opinion: Pivotal studies on ibandronic acid efficacy in terms of antifracture effects on nonvertebral fractures had some intrinsic limitations. However, a large body of indirect evidence suggests that ibandronate has significantly sustained vertebral and nonvertebral antifracture efficacies in women with postmenopausal Osteoporosis, in comparison to those observed with other nitrogen-containing bisphosphonates. Discrepancies in efficacy between the available bisphosphona...
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Osteoporosis Treatment: why ibandronic acid?
'Informa Healthcare', 2013Co-Authors: Maurizio Rossini, Giovanni Orsolini, Silvano Adami, Vidya Satheesn Kunnathully, Davide GattiAbstract:INTRODUCTION:In this article, we have summarized the specific evidence on ibandronic acid (or ibandronate) efficacy, tolerability, and feasibility acquired from trials and clinical use.AREAS COVERED:This critical review focuses on evidence from randomized controlled clinical trials, meta-analyses, surrogate markers, bridging trials, long-term extension studies, observational studies, clinical experiences in Osteoporosis in addition to postmenopausal Treatment adherence in clinical practice, and safety profile of ibandronic acid.EXPERT OPINION:Pivotal studies on ibandronic acid efficacy in terms of antifracture effects on nonvertebral fractures had some intrinsic limitations. However, a large body of indirect evidence suggests that ibandronate has significantly sustained vertebral and nonvertebral antifracture efficacies in women with postmenopausal Osteoporosis, in comparison to those observed with other nitrogen-containing bisphosphonates. Discrepancies in efficacy between the available bisphosphonate regimens appear to be a function of dose rather than to inherent differences in their respective therapeutic potential. Drugs or Treatment regimens that minimize the risk of osteoporotic fractures and make the Treatment of Osteoporosis more convenient and suitable for patients are preferred: ibandronic acid marketed at oral doses of 150 mg once monthly and 3 mg quarterly as intravenous injection has these characteristics. The safety profile of ibandronic acid Treatment appears to be good overall and in some cases better than that of other nitrogen-containing bisphosphonates
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relationship between bone mineral density changes with denosumab Treatment and risk reduction for vertebral and nonvertebral fractures
Journal of Bone and Mineral Research, 2012Co-Authors: M Austin, Silvano Adami, Y C Yang, Eric Vittinghoff, Steven Boonen, Douglas C Bauer, G Bianchi, Michael A Bolognese, Claus Christiansen, Richard EastellAbstract:Dual-energy X-ray absorptiometric bone mineral density (DXA BMD) is a strong predictor of fracture risk in untreated patients. However, previous patient-level studies suggest that BMD changes explain little of the fracture risk reduction observed with Osteoporosis Treatment. We investigated the relevance of DXA BMD changes as a predictor for fracture risk reduction using data from the FREEDOM trial, which randomly assigned placebo or denosumab 60 mg every 6 months to 7808 women aged 60 to 90 years with a spine or total hip BMD T-score 100%] and 72% [95% CI: 24% - >100%], respectively). Previous patient-level studies may have underestimated the strength of the relationship between BMD change and the effect of Treatment on fracture risk or this relationship may be unique to denosumab.
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fracture incidence and characterization in patients on Osteoporosis Treatment the icaro study
Journal of Bone and Mineral Research, 2006Co-Authors: Silvano Adami, Salvatore Minisola, L Sinigaglia, Giancarlo Isaia, Giovanni Luisetto, R Gentilella, D Agnusdei, Nicoletta Iori, Ranuccio NutiAbstract:None of the available Osteoporosis therapies have been shown to completely abolish the risk of fractures. In clinical practice, the outcome may be even poorer. In 880 patients prescribed with antiresorptives (alendronate, risedronate, and raloxifene) for >1 year, a fragility fracture was recorded in 8.9%/year of them. This incidence is considerably higher than that observed in randomized clinical trials, and it was significantly related to poor compliance and lack of supplementation with calcium and vitamin D. Introduction: Osteoporotic fracture is one of the most important public health concerns among the elderly. Currently available therapies have been shown to significantly decrease the risk of fracture, although none of them completely abolishes this risk. In clinical practice, poor Treatment response may also result from a number of other factors. Materials and Methods: The Incidence and ChAracterization of inadequate clinical Responders in Osteoporosis (ICARO) is a multicenter, observational study carried out in Italy. It aimed to analyze, in postmenopausal women with established Osteoporosis, the risk factors for an “inadequate clinical response” to drug therapy, defined as the occurrence of new vertebral or nonvertebral fragility fractures in patients prescribed, for at least 1 year, alendronate, risedronate, or raloxifene, with a compliance >50%. Results: In 880 patients treated with antiresorptive agents for a median of 2.0 years (95% CI: 1.0–4.5) years, the “inadequate clinical responder (ICR)” subjects over the observation period were 220 (25%), with an annual incidence of 8.9%. ICRs, compared with “adequate clinical responders (ACRs),” had more preTreatment fractures and were treated longer (2.8 versus 1.8 years; p < 0.001). After multiple adjustment for these confounding factors, significant determinants of inadequate clinical response were a poorer Treatment compliance and a less frequent co-administration of calcium and vitamin D supplements. Conclusions: The incidence of fractures during Treatment with antiresorptive agents in a clinical setting is considerably higher than that observed in randomized clinical trials. Inadequate compliance to Treatment and lack of supplementation of calcium and vitamin D are major determinants of this poor response.
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determinants of adherence to Osteoporosis Treatment in clinical practice
Osteoporosis International, 2006Co-Authors: Maurizio Rossini, Gerolamo Bianchi, O Di Munno, Sandro Giannini, Salvatore Minisola, L Sinigaglia, Silvano AdamiAbstract:Poor adherence to prescribed Treatments is widespread in clinical practice and this can lead to potentially life-threatening events. This problem is apparently very common for Osteoporosis Treatment but the causes of discontinuation and low compliance are complex and poorly defined. Global adherence to Osteoporosis Treatment was specifically addressed in a nation-wide survey carried out in 9851 postmenopausal women referred to 141 Italian centres for Osteoporosis management for a follow-up assessment, at least one year after having been prescribed a Treatment with one of the following drugs: calcium±vitamin D supplements alone (CaVitD), hormone replacement therapy (HRT), raloxifene 60 mg (RLX), intramuscular clodronate 100 mg/7-14 days (CLOD), risedronate 5 mg/day (RIS) and alendronate 10mg/daily (ALN10) or 70 mg once weekly (ALN OW). Overall 19.1% of the patients discontinued the prescribed drug before attending the bone mass re-evaluations, more than half of them within the first 6 months. The discontinuation rate was significantly different between the Treatments. The medications most frequently interrupted within one year were CLOD (28.7%; p<0.01 versus any other Treatment), while by far the least interrupted was ALN-OW (6.9%; p<0.001 versus any other Treatment). The most frequent reasons for discontinuation were drug related side effects, insufficient motivation to Treatment and fear of side effects. The prevalence of the reasons for discontinuation were different among Treatments: safety concerns were very common for HRT, lack of motivation was the most common cause for CaVitD and CLOD, and drug related side effects for RIS, ALN and RLX. Persistence to Treatment was significantly higher in patients with previous vertebral fractures, densitometric Osteoporosis, on corticosteroid or anti-inflammatory Treatments. A significantly increased risk of Treatment interruption was found among patients on benzodiazepine or gastro-protective agents and in patients in whom a bone measurement was not readily available. The highest compliance to recommended dosing was observed with ALN OW and HRT (p<0.001 versus any other) and the lowest for CaVitD (p<0.01 versus any other). Poor Treatment compliance (<50% drug taken) was significantly related to benzodiazepine and gastroprotective use, while a significantly better compliance was associated with recognized risk factors for Osteoporosis: early menopause, low bone mass values values, previous vertebral fractures. The poorest adherence was observed when Treatments were prescribed by General practitioners (GPs), and orthopaedic surgeons (p<0.01 versus global mean). The results of this large survey of Italian osteoporotic women indicates that the most important determinant of both persistence and compliance to Treatment is the type of drug prescribed with a definite advantage of ALN-OW. Treatment compliance is particularly poor for CaVitD and this emphasizes the need for new ways to supplement at least vitamin D. The main reasons for discontinuation are side effects and lack of motivation while the best Treatment adherence was observed in patients with severe and well documented Osteoporosis.
Sumit R Majumdar - One of the best experts on this subject based on the ideXlab platform.
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change in bone mineral density is an indicator of Treatment related antifracture effect in routine clinical practice a registry based cohort study
Annals of Internal Medicine, 2016Co-Authors: William D Leslie, Sumit R Majumdar, Suzanne N Morin, Lisa M LixAbstract:Background Whether change in bone mineral density (BMD) is an accurate indicator of antifracture effect in clinical practice is unknown. Objective To evaluate repeated BMD testing as an indicator of Treatment-related fracture risk reduction. Design Registry-based cohort study. Setting Manitoba, Canada. Patients 6629 women aged 40 years or older initiating Osteoporosis Treatment with 2 consecutive dual-energy x-ray absorptiometry scans (mean interval, 4.5 years). Measurements Change in BMD between the first and second dual-energy x-ray absorptiometry scans categorized as stable, detectable decrease, or detectable increase. Incident fractures were ascertained from health services data. Results During a mean of 9.2 years, 910 (13.7%) women developed incident fractures, including 198 with hip fractures. After adjustment for baseline fracture probability, women with a detectable decrease in total hip BMD compared with stable BMD had an absolute increase of 2.9% (95% CI, 1.5% to 4.4%) and 5.5% (CI, 2.8% to 8.1%) in the 5- and 10-year cumulative incidence of any fracture, respectively. In contrast, risk for any fracture in women with a detectable increase in total hip BMD was 1.3% (CI, 0.4% to 2.2%) and 2.6% (CI, 0.7% to 4.5%) lower after 5 and 10 years, respectively. Consistent results were seen for change in femoral neck and lumbar spine BMD and across a range of subgroup analyses. Limitation Lack of standardization in the BMD testing interval. Conclusion Treatment-related increases in total hip BMD are associated with reduced fracture risk compared with stable BMD, whereas decreases in BMD are associated with greater risk for fractures. Monitoring BMD in clinical practice may help to identify women with a suboptimal response to Osteoporosis Treatment. Primary funding source None.
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change in bone mineral density is an indicator of Treatment related antifracture effect in routine clinical practice
Annals of Internal Medicine, 2016Co-Authors: William D Leslie, Sumit R Majumdar, Suzanne N Morin, Lisa M LixAbstract:The role of repeated bone mineral density testing in women receiving Osteoporosis Treatment is unclear. This population-based cohort study examined the relationship between changes in bone mineral ...
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cost effectiveness of a multifaceted intervention to improve quality of Osteoporosis care after wrist fracture
Osteoporosis International, 2011Co-Authors: David A Hanley, Sumit R Majumdar, Finlay A Mcalister, Anthony S Russell, Brian H Rowe, Walter P Maksymowych, Donald W Morrish, Douglas A Lier, James A JohnsonAbstract:In a randomized trial, a multifaceted intervention tripled rates of Osteoporosis Treatment in older patients with wrist fracture. An economic analysis of the trial now demonstrates that the intervention tested “dominates” usual care: over a lifetime horizon, it reduces fracture, increases quality-adjusted life years, and saves the healthcare system money. In a randomized trial (N = 272), we reported a multifaceted quality improvement intervention directed at older patients and their physicians could triple rates of Osteoporosis Treatment within 6 months of a wrist fracture when compared with usual care (22% vs 7%). Alongside the trial, we conducted an economic evaluation. Using 1-year outcome data from our trial and micro-costing time-motion studies, we constructed a Markov decision-analytic model to determine cost-effectiveness of the intervention compared with usual care over the patients’ remaining lifetime. We took the perspective of third-party healthcare payers. In the base case, costs and benefits were discounted at 3% and expressed in 2006 Canadian dollars. One-way deterministic and probabilistic sensitivity analyses were conducted. Median age of patients was 60 years, 77% were women, and 72% had low bone mineral density (BMD). The intervention cost $12 per patient. Compared with usual care, the intervention strategy was dominant: for every 100 patients receiving the intervention, three fractures (one hip fracture) would be prevented, 1.1 quality-adjusted life year gained, and $26,800 saved by the healthcare system over their remaining lifetime. The intervention dominated usual care across numerous one-way sensitivity analyses: with respect to cost, the most influential parameter was drug price; in terms of effectiveness, the most influential parameter was rate of BMD testing. The intervention was cost saving in 80% of probabilistic model simulations. For outpatients with wrist fractures, our multifaceted Osteoporosis intervention was cost-effective. Healthcare systems implementing similar interventions should expect to save money, reduce fractures, and gain quality-adjusted life expectancy.
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use of a case manager to improve Osteoporosis Treatment after hip fracture results of a randomized controlled trial
JAMA Internal Medicine, 2007Co-Authors: Sumit R Majumdar, David A Hanley, Walter P Maksymowych, Douglas A Lier, Lauren A Beaupre, Charles H Harley, Angela Juby, John G Cinats, Neil R Bell, Donald W MorrishAbstract:Background Patients who survive hip fracture are at high risk of recurrent fractures, but rates of Osteoporosis Treatment 1 year after sustaining a fracture are less than 10% to 20%. We have developed an Osteoporosis case manager intervention. The case manager educated patients, arranged bone mineral density tests, provided prescriptions, and communicated with primary care physicians. The intervention was compared with usual care in a randomized controlled trial. Methods We recruited from all hospitals that participate in the Capital Health system (Alberta, Canada), including patients 50 years or older who had sustained a hip fracture and excluding those who were receiving Osteoporosis Treatment or who lived in a long-term care facility. Primary outcome was bisphosphonate therapy 6 months after fracture; secondary outcomes included bone mineral density testing, appropriate care (bone mineral density testing and Treatment if bone mass was low), and intervention costs. Results We screened 2219 patients and allocated 220, as follows: 110 to the intervention group and 110 to the control group. Median age was 74 years, 60% were women, and 37% reported having had previous fractures. Six months after hip fracture, 56 patients in the intervention group (51%) were receiving bisphosphonate therapy compared with 24 patients in the control group (22%) (adjusted odds ratio, 4.7; 95% confidence interval, 2.4-8.9; P P P Conclusion For a modest cost, a case manager was able to substantially increase rates of Osteoporosis Treatment in a vulnerable elderly population at high risk of future fractures. Trial Registration clinicaltrials.gov Identifier:NCT00175175
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persistence reproducibility and cost effectiveness of an intervention to improve the quality of Osteoporosis care after a fracture of the wrist results of a controlled trial
Osteoporosis International, 2007Co-Authors: Sumit R Majumdar, David A Hanley, Anthony S Russell, Ivan P Steiner, Walter P Maksymowych, Donald W Morrish, Douglas A Lier, James A Johnson, Sandra Blitz, Brian R HolroydAbstract:Introduction Older patients with fragility fractures are not commonly tested or treated for Osteoporosis. Compared to usual care, a previously reported intervention led to 30% absolute increases in Osteoporosis Treatment within 6 months of wrist fracture. Our objective was to examine longer-term outcomes, reproducibility, and cost-effectiveness of this intervention.
William D Leslie - One of the best experts on this subject based on the ideXlab platform.
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change in bone mineral density is an indicator of Treatment related antifracture effect in routine clinical practice a registry based cohort study
Annals of Internal Medicine, 2016Co-Authors: William D Leslie, Sumit R Majumdar, Suzanne N Morin, Lisa M LixAbstract:Background Whether change in bone mineral density (BMD) is an accurate indicator of antifracture effect in clinical practice is unknown. Objective To evaluate repeated BMD testing as an indicator of Treatment-related fracture risk reduction. Design Registry-based cohort study. Setting Manitoba, Canada. Patients 6629 women aged 40 years or older initiating Osteoporosis Treatment with 2 consecutive dual-energy x-ray absorptiometry scans (mean interval, 4.5 years). Measurements Change in BMD between the first and second dual-energy x-ray absorptiometry scans categorized as stable, detectable decrease, or detectable increase. Incident fractures were ascertained from health services data. Results During a mean of 9.2 years, 910 (13.7%) women developed incident fractures, including 198 with hip fractures. After adjustment for baseline fracture probability, women with a detectable decrease in total hip BMD compared with stable BMD had an absolute increase of 2.9% (95% CI, 1.5% to 4.4%) and 5.5% (CI, 2.8% to 8.1%) in the 5- and 10-year cumulative incidence of any fracture, respectively. In contrast, risk for any fracture in women with a detectable increase in total hip BMD was 1.3% (CI, 0.4% to 2.2%) and 2.6% (CI, 0.7% to 4.5%) lower after 5 and 10 years, respectively. Consistent results were seen for change in femoral neck and lumbar spine BMD and across a range of subgroup analyses. Limitation Lack of standardization in the BMD testing interval. Conclusion Treatment-related increases in total hip BMD are associated with reduced fracture risk compared with stable BMD, whereas decreases in BMD are associated with greater risk for fractures. Monitoring BMD in clinical practice may help to identify women with a suboptimal response to Osteoporosis Treatment. Primary funding source None.
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change in bone mineral density is an indicator of Treatment related antifracture effect in routine clinical practice
Annals of Internal Medicine, 2016Co-Authors: William D Leslie, Sumit R Majumdar, Suzanne N Morin, Lisa M LixAbstract:The role of repeated bone mineral density testing in women receiving Osteoporosis Treatment is unclear. This population-based cohort study examined the relationship between changes in bone mineral ...
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proceedings of the 2015 santa fe bone symposium clinical applications of scientific advances in Osteoporosis and metabolic bone disease
Journal of Clinical Densitometry, 2016Co-Authors: Michael E Lewiecki, Michael R Mcclung, Roland Baron, John P Bilezikian, Robert E Gagel, Mary B Leonard, William D Leslie, Paul D MillerAbstract:The 2015 Santa Fe Bone Symposium was a venue for healthcare professionals and clinical researchers to present and discuss the clinical relevance of recent advances in the science of skeletal disorders, with a focus on Osteoporosis and metabolic bone disease. Symposium topics included new developments in the translation of basic bone science to improved patient care, Osteoporosis Treatment duration, pediatric bone disease, update of fracture risk assessment, cancer Treatment-related bone loss, fracture liaison services, a review of the most significant studies of the past year, and the use of telementoring with Bone Health Extension for Community Healthcare Outcomes, a force multiplier to improve the care of Osteoporosis in underserved communities.
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a population based study of Osteoporosis testing and Treatment following introduction of a new bone densitometry service
Osteoporosis International, 2005Co-Authors: William D Leslie, Lisa M Lix, Leonard Macwilliam, Patricia Caetano, Gregory S FinlaysonAbstract:Bone density measurement plays a key role in the initial diagnostic assessment of Osteoporosis and in targeting pharmacologic therapies. The impact of access to dual-energy X-ray absorptiometry (DXA) on physician prescribing habits is unclear, however. We were able to directly evaluate the change in physician Osteoporosis testing and prescribing following introduction of a DXA testing service in a geographic region that had previously had very limited access. This evaluation was conducted in the province of Manitoba, Canada, which has a provincially based bone density testing program and maintains a population-based bone density database that can be linked with administrative health data sources including drug prescriptions. The province of Manitoba was geographically partitioned into the urban and rural health regions serviced by the new program (urbannew and ruralnew) and the remaining urban and rural health regions which had relatively unchanged DXA access during this period (urbancontrol and ruralcontrol). Regression models of DXA testing rates and Osteoporosis prescription rates were created for all older women in these regions. There was a statistically significant increase in bone density testing and BMD-guided Osteoporosis Treatment in the urbannew and ruralnew regions following introduction of the DXA testing service, relative to the control regions. Although the overall rate of empiric postfracture and preventive Osteoporosis Treatment did not show a specific region effect, when analysis was limited to nonhormonal agents there was a significant reduction in preventive and empiric postfracture Treatment in some subgroups of women. These results suggest that the local availability of the bone density testing service led to an increase in objective test-guided therapy with some reduction in the use of empiric and preventive strategies and had a neutral effect on overall use of these agents.
Stefan Goemaere - One of the best experts on this subject based on the ideXlab platform.
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A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with Osteoporosis: effects on bone density and fracture.
Menopause (New York N.Y.), 2015Co-Authors: Santiago Palacios, Amy B. Levine, Jacques P. Brown, Stuart L Silverman, Tobie De Villiers, Robert Williams, Stefan Goemaere, Fiorenzo De Cicco Nardone, Teresa Hines, Sebastian MirkinAbstract:AbstractObjectiveIn a 3-year randomized, double-blind, Osteoporosis Treatment study (N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly (P < 0.05) reduced the risk of new vertebral fractures by 42% and 37%, respectively, compared with placebo in postmenopausal women with osteoporosi
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strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with Osteoporosis Treatment of peripheral Osteoporosis tropos study
Obstetrical & Gynecological Survey, 2005Co-Authors: Jean-yves Reginster, M C De Vernejoul, Ego Seeman, Jeanpierre Devogelaer, Silvano Adami, J E Compston, C Phenekos, Diaz M Curiel, A Sawicki, Stefan GoemaereAbstract:ABSTRACT Strontium ranelate is an orally active drug that may permit ongoing production of bone while at the same time reducing bone resorption. New vertebral fractures reportedly are less frequent in postmenopausal women who receive this agent. The Treatment of Peripheral Osteoporosis Study (TROPOS) is a randomized, double-blind, placebo-controlled trial designed to show whether strontium ranelate prevents nonvertebral fractures in European and Australian postmenopausal women who had a bone mineral density (BMD) equivalent to a T-score less than −2.5. Participants were 74 years or older, or 70 to 74 years if an additional fracture risk factor was present. Either strontium ranelate in a daily dose of 2 g or placebo was given to 5091 postmenopausal women with Osteoporosis. Major statistical analysis was undertaken over 3 years of Treatment. The intention-to-treat population totaled 4932 patients. The relative risk (RR) of nonvertebral fractures was reduced 16% during 3 years of follow up, and major nonvertebral osteoporotic factors were reduced by 19%. The RR for hip fracture was reduced by 15%—not a statistically significant result. Hip fractures were reduced 36% in women aged 74 years and older who had a BMD T-score of −3 or less. Patients given strontium ranelate had a 39% reduction in the RR of new vertebral fractures over 3 years. The RR of a first vertebral fracture was lowered by 45%. BMD increased significantly in both the total hip and femoral neck. Treatment was well-tolerated, and changes in serum levels of calcium, phosphorus, and parathyroid hormone were not of clinical importance. Nonvertebral fractures, particularly hip fractures, are significantly less likely to occur in postmenopausal women with Osteoporosis who receive 2 g of strontium ranelate daily compared with placebo recipients. The investigators believe that this drug could be a helpful first-line Treatment for postmenopausal Osteoporosis.
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strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with Osteoporosis Treatment of peripheral Osteoporosis tropos study
Obstetrical & Gynecological Survey, 2005Co-Authors: Jean-yves Reginster, M C De Vernejoul, Ego Seeman, Jeanpierre Devogelaer, Silvano Adami, J E Compston, C Phenekos, Diaz M Curiel, A Sawicki, Stefan GoemaereAbstract:ABSTRACT Strontium ranelate is an orally active drug that may permit ongoing production of bone while at the same time reducing bone resorption. New vertebral fractures reportedly are less frequent in postmenopausal women who receive this agent. The Treatment of Peripheral Osteoporosis Study (TROPOS) is a randomized, double-blind, placebo-controlled trial designed to show whether strontium ranelate prevents nonvertebral fractures in European and Australian postmenopausal women who had a bone mineral density (BMD) equivalent to a T-score less than −2.5. Participants were 74 years or older, or 70 to 74 years if an additional fracture risk factor was present. Either strontium ranelate in a daily dose of 2 g or placebo was given to 5091 postmenopausal women with Osteoporosis. Major statistical analysis was undertaken over 3 years of Treatment. The intention-to-treat population totaled 4932 patients. The relative risk (RR) of nonvertebral fractures was reduced 16% during 3 years of follow up, and major nonvertebral osteoporotic factors were reduced by 19%. The RR for hip fracture was reduced by 15%—not a statistically significant result. Hip fractures were reduced 36% in women aged 74 years and older who had a BMD T-score of −3 or less. Patients given strontium ranelate had a 39% reduction in the RR of new vertebral fractures over 3 years. The RR of a first vertebral fracture was lowered by 45%. BMD increased significantly in both the total hip and femoral neck. Treatment was well-tolerated, and changes in serum levels of calcium, phosphorus, and parathyroid hormone were not of clinical importance. Nonvertebral fractures, particularly hip fractures, are significantly less likely to occur in postmenopausal women with Osteoporosis who receive 2 g of strontium ranelate daily compared with placebo recipients. The investigators believe that this drug could be a helpful first-line Treatment for postmenopausal Osteoporosis.
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teriparatide effects on vertebral fractures and bone mineral density in men with Osteoporosis Treatment and discontinuation of therapy
Osteoporosis International, 2005Co-Authors: Jean Kaufman, Robert Lindsay, Gail P Dalsky, Stefan Goemaere, Eric S Orwoll, San J Martin, A Hossain, Bruce H MitlakAbstract:Teriparatide (rhPTH[1-34]), a bone-forming agent for the Treatment of Osteoporosis, increases bone mineral density in men and women, and reduces the risk of fractures in women with Osteoporosis. However, fracture efficacy has not yet been confirmed in men. Further, there is limited information on the effect of withdrawal of teriparatide. The purpose of this manuscript is to report on bone mineral density and vertebral fracture incidence during a 42-month observation period, from the baseline of the previously reported Treatment study in men [1] through 30 months of postTreatment follow-up. Three hundred fifty-five men who were treated with once-daily self-injections of either placebo or 20 or 40 µg of teriparatide participated in the follow-up study. Bone mineral density gradually decreased following discontinuation of teriparatide therapy. However, the lumbar spine and total hip values remained significantly higher than baseline after 30 months of follow-up (p≤0.001). Antiresorptive Treatment prevented the decline and tended to further increase bone mineral density. Lateral thoracic lumbar radiographs obtained at baseline and 18 months after discontinuation of teriparatide were available for 279 men. Of these men, 11.7% assigned to placebo, 5.4% treated with teriparatide 20 µg, and 6.0% treated with teriparatide 40 µg had an incident vertebral fracture. In the combined teriparatide treated groups vs placebo, the risk of vertebral fracture was reduced 51% (nonsignificant, p=0.07). The incidence of moderate or severe fractures was significantly reduced by 83% (p=0.01). In conclusion, men who received teriparatide and who may have received follow-up antiresorptive therapy had a decreased risk of moderate and severe vertebral fractures.
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strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with Osteoporosis Treatment of peripheral Osteoporosis tropos study
The Journal of Clinical Endocrinology and Metabolism, 2005Co-Authors: Jean-yves Reginster, M C De Vernejoul, Ego Seeman, Jeanpierre Devogelaer, Silvano Adami, J E Compston, C Phenekos, Diaz M Curiel, A Sawicki, Stefan GoemaereAbstract:Background: Strontium ranelate, a new oral drug shown to reduce vertebral fracture risk in postmenopausal women with Osteoporosis, was studied in the Treatment of Peripheral Osteoporosis (TROPOS) study to assess its efficacy and safety in preventing nonvertebral fractures also. Methods: Strontium ranelate (2 g/d) or placebo were randomly allocated to 5091 postmenopausal women with Osteoporosis in a double-blind placebo-controlled 5-yr study with a main statistical analysis over 3 yr of Treatment. Findings: In the entire sample, relative risk (RR) was reduced by 16% for all nonvertebral fractures (P = 0.04), and by 19% for major fragility fractures (hip, wrist, pelvis and sacrum, ribs and sternum, clavicle, humerus) (P = 0.031) in strontium ranelate-treated patients in comparison with the placebo group. Among women at high risk of hip fracture ( age >= 74 yr and femoral neck bone mineral density T score <=-3, corresponding to -2.4 according to NHANES reference) (n = 1977), the RR reduction for hip fracture was 36% (P = 0.046). RR of vertebral fractures was reduced by 39% (P < 0.001) in the 3640 patients with spinal x-rays and by 45% in the subgroup without prevalent vertebral fracture. Strontium ranelate increased bone mineral density throughout the study, reaching at 3 yr (P < 0.001): +8.2% (femoral neck) and +9.8% (total hip). Incidence of adverse events (AEs) was similar in both groups. Conclusion: This study shows that strontium ranelate significantly reduces the risk of all nonvertebral and in a high-risk subgroup, hip fractures over a 3-yr period, and is well tolerated. It confirms that strontium ranelate reduces vertebral fractures. Strontium ranelate offers a safe and effective means of reducing the risk of fracture associated with Osteoporosis.
Lisa M Lix - One of the best experts on this subject based on the ideXlab platform.
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change in bone mineral density is an indicator of Treatment related antifracture effect in routine clinical practice a registry based cohort study
Annals of Internal Medicine, 2016Co-Authors: William D Leslie, Sumit R Majumdar, Suzanne N Morin, Lisa M LixAbstract:Background Whether change in bone mineral density (BMD) is an accurate indicator of antifracture effect in clinical practice is unknown. Objective To evaluate repeated BMD testing as an indicator of Treatment-related fracture risk reduction. Design Registry-based cohort study. Setting Manitoba, Canada. Patients 6629 women aged 40 years or older initiating Osteoporosis Treatment with 2 consecutive dual-energy x-ray absorptiometry scans (mean interval, 4.5 years). Measurements Change in BMD between the first and second dual-energy x-ray absorptiometry scans categorized as stable, detectable decrease, or detectable increase. Incident fractures were ascertained from health services data. Results During a mean of 9.2 years, 910 (13.7%) women developed incident fractures, including 198 with hip fractures. After adjustment for baseline fracture probability, women with a detectable decrease in total hip BMD compared with stable BMD had an absolute increase of 2.9% (95% CI, 1.5% to 4.4%) and 5.5% (CI, 2.8% to 8.1%) in the 5- and 10-year cumulative incidence of any fracture, respectively. In contrast, risk for any fracture in women with a detectable increase in total hip BMD was 1.3% (CI, 0.4% to 2.2%) and 2.6% (CI, 0.7% to 4.5%) lower after 5 and 10 years, respectively. Consistent results were seen for change in femoral neck and lumbar spine BMD and across a range of subgroup analyses. Limitation Lack of standardization in the BMD testing interval. Conclusion Treatment-related increases in total hip BMD are associated with reduced fracture risk compared with stable BMD, whereas decreases in BMD are associated with greater risk for fractures. Monitoring BMD in clinical practice may help to identify women with a suboptimal response to Osteoporosis Treatment. Primary funding source None.
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change in bone mineral density is an indicator of Treatment related antifracture effect in routine clinical practice
Annals of Internal Medicine, 2016Co-Authors: William D Leslie, Sumit R Majumdar, Suzanne N Morin, Lisa M LixAbstract:The role of repeated bone mineral density testing in women receiving Osteoporosis Treatment is unclear. This population-based cohort study examined the relationship between changes in bone mineral ...
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a population based study of Osteoporosis testing and Treatment following introduction of a new bone densitometry service
Osteoporosis International, 2005Co-Authors: William D Leslie, Lisa M Lix, Leonard Macwilliam, Patricia Caetano, Gregory S FinlaysonAbstract:Bone density measurement plays a key role in the initial diagnostic assessment of Osteoporosis and in targeting pharmacologic therapies. The impact of access to dual-energy X-ray absorptiometry (DXA) on physician prescribing habits is unclear, however. We were able to directly evaluate the change in physician Osteoporosis testing and prescribing following introduction of a DXA testing service in a geographic region that had previously had very limited access. This evaluation was conducted in the province of Manitoba, Canada, which has a provincially based bone density testing program and maintains a population-based bone density database that can be linked with administrative health data sources including drug prescriptions. The province of Manitoba was geographically partitioned into the urban and rural health regions serviced by the new program (urbannew and ruralnew) and the remaining urban and rural health regions which had relatively unchanged DXA access during this period (urbancontrol and ruralcontrol). Regression models of DXA testing rates and Osteoporosis prescription rates were created for all older women in these regions. There was a statistically significant increase in bone density testing and BMD-guided Osteoporosis Treatment in the urbannew and ruralnew regions following introduction of the DXA testing service, relative to the control regions. Although the overall rate of empiric postfracture and preventive Osteoporosis Treatment did not show a specific region effect, when analysis was limited to nonhormonal agents there was a significant reduction in preventive and empiric postfracture Treatment in some subgroups of women. These results suggest that the local availability of the bone density testing service led to an increase in objective test-guided therapy with some reduction in the use of empiric and preventive strategies and had a neutral effect on overall use of these agents.
