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See detailSafety and tolerability of odanacatib therapy in postmenopausal women with osteoporosis: results from the phase III long-term odanacatib fracture trial
Papapoulos, S; McClung, MR; Langdahl, B et al

in Osteoporosis International (2014), 25(5), 604-605

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See detailOdanacatib anti-fracture efficacy and safety in postmenopausal women with osteoporosis: results from the phase III long-term odanacatib fracture trial
McClung, MR; Langdahl, B; Papapoulos, S et al

in Osteoporosis International (2014), 25(5), 573-575

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See detailOdanacatib anti-fracture efficacy and safety in postmenopausal women with osteoporosis: results from the phase III long-term odanacatib fracture trial
McClung, MR; Langdahl, B; Papapoulos, S et al

in Arthritis and Rheumatism (2014), 66(11), 987

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See detailPercentage of women achieving non-osteoporotic BMD T-scores at the spine and hip over 8 years of denosumab treatment
Ferrari, S; Libanati, C; Lin, CJF et al

in Arthritis and Rheumatism (2014), 66(11), 986-987

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See detailLoss of hip bone mineral density over time is associated with spine and hip fracture incidence in osteoporotic postmenopausal women.
Bruyère, Olivier ULg; Varela, A. R.; Adami, S. et al

in European journal of epidemiology (2009), 24

The objective of the study assess the relationship between bone mineral density (BMD) loss over time and fracture incidence in postmenopausal women. This is a posthoc analysis that includes women from the ... [more ▼]

The objective of the study assess the relationship between bone mineral density (BMD) loss over time and fracture incidence in postmenopausal women. This is a posthoc analysis that includes women from the placebo group of two large randomized controlled trials having assessed the efficacy of a new anti-osteoporotic drug. BMD was assessed every 6 months during 3 years at the lumbar spine, the femoral neck and the total proximal femur. Vertebral fractures were assessed using a semiquantitative method. Hip fractures were based on written documentation. All patients received calcium and vitamin D. In the present study that included 1,775 patients (with complete data at baseline and after 3 years), the logistic regression analysis, adjusted for covariates, showed that 3-year change in lumbar BMD was not statistically associated with the new vertebral fractures after 3 years. However, femoral neck and total proximal femur BMD changes was statistically correlated with the incidence of new vertebral fractures (P < 0.001). When considering change in BMD after the first year of follow-up, a decrease in total proximal femur BMD was statistically associated with an increase in the incidence of new vertebral fractures during the last 2 years of follow-up (P = 0.048). The 3-year change in femoral neck and total proximal BMD was statistically correlated with the incidence of hip and fragility fracture after 3 years (all P < 0.001). In this elderly osteoporotic population receiving calcium and vitamin D, a decrease in hip BMD after 1 or 3 year of follow-up, is associated with an increased risk of fracture incidence. However, spine BMD changes do not influence vertebral fracture incidence. [less ▲]

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See detailIbandronate for the prevention of nonvertebral fractures: a pooled analysis of individual patient data.
Cranney, Ann; Wells, G. A.; Yetisir, E. et al

in Osteoporosis International (2009), 20(2), 291-7

SUMMARY: This analysis was conducted to assess the effect of high versus lower doses of ibandronate on nonvertebral fractures. The results were adjusted for clinical fracture, age, and bone density. The ... [more ▼]

SUMMARY: This analysis was conducted to assess the effect of high versus lower doses of ibandronate on nonvertebral fractures. The results were adjusted for clinical fracture, age, and bone density. The treatment effect was dose-dependent. Higher doses of ibandronate significantly reduced the risk of nonvertebral fractures more effectively compared with lower doses. INTRODUCTION: The objective of this study was to assess the efficacy of different doses of ibandronate on nonvertebral fractures in a pooled analysis. METHODS: Eight randomized trials of ibandronate were reviewed for inclusion. Alternative definitions of high versus low doses based on annual cumulative exposure (ACE) were explored. A time-to-event analysis was conducted using Kaplan-Meier methodology. Hazard ratios (HR) were derived using Cox regression and adjusted for covariates. RESULTS: Combining higher ACE doses of > or = 10.8 mg (150 mg once monthly, 3 mg i.v. quarterly, and 2 mg i.v. every 2 months) versus ACE doses of 5.5 mg, from two trials, resulted in an HR 0.62 (95% CI 0.396-0.974, p = 0.038). There was a dose-response trend with increasing ACE doses (7.2-12 mg) versus ACE of 5.5 mg. CONCLUSIONS: A dose-response effect on nonvertebral fractures was observed when comparing high with low ACE doses. A significant reduction in nonvertebral fractures was noted when pooling data from trials using ACE doses of > or = 10.8 mg versus ACE < or = 7.2 mg; and with ACE > or = 10.8 mg versus ACE of 5.5 mg (38% reduction). Higher ibandronate dose levels (150 mg monthly or 3 mg i.v. quarterly) significantly reduced nonvertebral fracture risk in postmenopausal women. [less ▲]

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See detailEffects of Strontium Ranelate on Spinal Osteoarthritis Progression
Bruyère, Olivier ULg; Delferriere, D.; Roux, C. et al

in Annals of the Rheumatic Diseases (2008), 67(3), 335-9

OBJECTIVE: The aim of this study was to determine whether a 3-year treatment with strontium ranelate could delay the progression of spinal osteoarthritis (OA). METHODS: This study was a post-hoc analysis ... [more ▼]

OBJECTIVE: The aim of this study was to determine whether a 3-year treatment with strontium ranelate could delay the progression of spinal osteoarthritis (OA). METHODS: This study was a post-hoc analysis of pooled data from the Spinal Osteoporosis Therapeutic Intervention (SOTI) and TReatment Of Peripheral OSteoporosis (TROPOS) trials performed on 1105 women with osteoporosis and concomitant radiological spinal OA at baseline, and for whom lumbar x-rays were available at baseline and over the 3-year treatment period. The presence and severity of osteophytes, disc space narrowing and sclerosis in the lumbar intervertebral spaces was graded according to a validated method, and an overall OA score was calculated for each intervertebral space. Back pain (measured on a five-point Likert scale only in SOTI) and health-related quality of life (SF-36 questionnaire) were assessed at baseline and after 3 years. Patients who suffered an incident or progressive vertebral fracture during the study were excluded from the analysis. RESULTS: The proportion of patients with worsening overall spinal OA score was reduced by 42% in the strontium ranelate group, compared with placebo (RR, 0.58; 95% CI, 0.42 to 0.79; p = 0.0005). Significantly more patients in the strontium ranelate group experienced an improvement in back pain after 3 years, compared with placebo (p = 0.03), while no significant difference was observed in terms of health-related quality of life between these patient groups. CONCLUSIONS: The results of this post-hoc analysis suggest that strontium ranelate could reduce the progression of the radiographic features of spinal OA and back pain in women with osteoporosis and prevalent spinal OA. [less ▲]

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See detailEfficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 Year results from the MOBILE study (Annals of the Rheumatic Diseases (2006) 65, (654-661))
REGINSTER, Jean-Yves ULg; Adami, S.; Lakatos, P. et al

in Annals of the Rheumatic Diseases (2008), 67(2), 280

[No abstract available]

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See detailProgressive bone density gains with once-monthly oral ibandronate: the MOBILE study long-term extension
Lewiecki, EM; Reginster, Jean-Yves ULg; Elizondo-Alanis, LJ et al

in Arthritis and Rheumatism (2006, November), 54

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See detailEfficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study
Reginster, Jean-Yves ULg; Adami, S.; Lakatos, P. et al

in Annals of the Rheumatic Diseases (2006), 65(5), 654-661

BACKGROUND: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been ... [more ▼]

BACKGROUND: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem. OBJECTIVE: To confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis. METHODS: MOBILE, a randomised, phase III, non-inferiority study, compared the efficacy and safety of once-monthly ibandronate with daily ibandronate, which has previously been shown to reduce vertebral fracture risk in comparison with placebo. RESULTS: 1609 postmenopausal women were randomised. Substantial increases in lumbar spine bone mineral density (BMD) were seen in all treatment arms: 5.0%, 5.3%, 5.6%, and 6.6% in the daily and once-monthly groups (50 + 50 mg, 100 mg, and 150 mg), respectively. It was confirmed that all once-monthly regimens were at least as effective as daily treatment, and in addition, 150 mg was found to be better (p<0.001). Substantial increases in proximal femur (total hip, femoral neck, trochanter) BMD were seen; 150 mg produced the most pronounced effect (p<0.05 versus daily treatment). Independent of the regimen, most participants (70.5-93.5%) achieved increases above baseline in lumbar spine or total hip BMD, or both. Pronounced decreases in the biochemical marker of bone resorption, sCTX, observed in all arms after 3 months, were maintained throughout. The 150 mg regimen consistently produced greater increases in BMD and sCTX suppression than the 100 mg and daily regimens. Ibandronate was well tolerated, with a similar incidence of adverse events across groups. CONCLUSIONS: Once-monthly oral ibandronate is at least as effective and well tolerated as daily treatment. Once-monthly administration may be more convenient for patients and improve therapeutic adherence, thereby optimising outcomes. [less ▲]

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See detailStrontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) study
Reginster, Jean-Yves ULg; Seeman, E.; De Vernejoul, M. C. et al

in Journal of Clinical Endocrinology and Metabolism (2005), 90(5), 2816-2822

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 ... [more ▼]

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. [less ▲]

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See detailLumiracoxib is effective in the treatment of osteoarthritis of the knee: a 13 week, randomised, double blind study versus placebo and celecoxib
Tannenbaum, H.; Berenbaum, F.; Reginster, Jean-Yves ULg et al

in Annals of the Rheumatic Diseases (2004), 63(11), 1419-1426

Objectives: To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis (OA) in a 13 week, multicentre, randomised, double blind study. Methods: After a 327 day washout ... [more ▼]

Objectives: To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis (OA) in a 13 week, multicentre, randomised, double blind study. Methods: After a 327 day washout period for non-steroidal anti-inflammatory drugs, 1702 patients with knee OA were randomised to lumiracoxib 200 or 400 mg once daily (od), celecoxib 200 mg od, or placebo (2:2:2:1). A visual analogue scale (VAS) pain intensity greater than or equal to40 mm was required. Primary efficacy variables were OA pain intensity (VAS mm) in the target knee, patient's global assessment of disease activity (VAS mm), and WOMAC pain subscale and total scores at 13 weeks. OA pain intensity, patient's and physician's global assessment of disease activity, and WOMAC (total and all subscale scores) were analysed by visit as secondary variables. Results: Lumiracoxib showed significant improvements in all primary and secondary variables compared with placebo. Lumiracoxib 200 mg od and celecoxib 200 mg od achieved similar improvements in OA pain intensity and functional status. Lumiracoxib 400 mg od demonstrated better efficacy for OA pain intensity and patient's global assessment of disease activity at weeks 2, 4, and 8 and similar efficacy at week 13 compared with celecoxib 200 mg od. The incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs was similar in each group. Conclusion: Lumiracoxib demonstrated significant improvement in OA pain intensity, patient's global assessment of disease activity, and the WOMAC pain subscale and total scores compared with placebo. Lumiracoxib was well tolerated in this study, with overall tolerability similar to that of placebo and celecoxib. [less ▲]

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See detailStrontium ranelate reduces the risk of vertebral and non-vertebral fractures in Caucasian women with post-menopausal osteoporosis.
Adami, S; Meunier, J; Devogelaer, JP et al

in Calcified Tissue International (2004), 74(S1), 37-38

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See detailOnce weekly alendronate produces a greater increase in bone mineral density than daily risedronate
Hosking, D; Adami, S; Felsenberg, D et al

in Calcified Tissue International (2003), 72

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See detailComparison of change in bone resorption and bone mineral density with once-weekly alendronate and daily risedronate: a randomised, placebo-controlled study
Hosking, D.; Adami, S.; Felsenberg, D. et al

in Current Medical Research & Opinion (2003), 19(5), 383-394

Objective: To compare the effects of alendronate (ALN) 70 mg once weekly (OW) and risedronate (RIS) 5 mg daily between-meal dosing on biochemical markers of bone turnover and bone mineral density (BMD) in ... [more ▼]

Objective: To compare the effects of alendronate (ALN) 70 mg once weekly (OW) and risedronate (RIS) 5 mg daily between-meal dosing on biochemical markers of bone turnover and bone mineral density (BMD) in postmenopausal women with osteoporosis. Research design and methods: This was a 3-month, randomised, double-blind, placebo-controlled study with a double-blind extension to 12 months. The study enrolled 549 postmenopausal women (ALN 219, RIS 222 and placebo (PBO) 108) who were : 60 years of age at outpatient centres. Main outcome measures: The primary endpoint was reduction in urine N-telopeptides of type 1 collagen (NTx) corrected for creatinine level at 3 months. Secondary parameters included change in BMD at the spine and hip at 6 and 12 months, NTx at 1, 6 and 12 months, and serum bone-specific alkaline phosphatase (BSAP) at 1, 3, 6 and 12 months. Adverse experiences (AEs) were recorded throughout the study for an assessment of treatment safety profiles and tolerability. Results: Over 3 months, ALN produced a significantly greater mean reduction in urine NTx than did RIS (-52% vs -32%, p < 0.001), which was maintained at 12 months. ALN produced a significantly greater mean BMD increase than did RIS at 6 months, and it was maintained at 12 months at the lumbar spine (4.8% vs 2.8%, p < 0.001) and total hip (2.7% vs 0.9%, p < 0.001), as well as at the trochanter and femoral neck. Significant reductions in BSAP with ALN compared to RIS were maintained over the 12 months of treatment. Study size did not allow for meaningful assessment of differences in fracture rates. Tolerability was generally similar between ALN, RIS and PBO, and the incidence of upper GI AEs causing discontinuation and oesophageal AEs was similar in the ALN and RIS groups. Conclusion: In this study, ALN 70 mg OW produced a 50% greater reduction in bone resorption as measured by urine NTx and significantly greater increases in lumbar spine and hip BMD than did RIS 5 mg daily. The treatments had similar safety profiles and were generally well-tolerated. Additional studies are needed comparing OW ALN with OW RIS, which became available after the commencement of the present study. [less ▲]

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See detailOnce weekly alendronate produces a greater increase in bone mineral density than daily risedronate
Hosking, D.; Adami, S.; Felsenberg, D. et al

in BONE (2003), 32(S7), 207

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See detailOnce weekly alendronate produces a greater decrease in bone resorption than does daily risedronate
Hosking, D.; Adami, S.; Felsenberg, D. et al

in Journal of Bone and Mineral Research (2002, September), 17(S1), 370

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See detailOnce weekly alendronate produces a greater decrease in bone resorption than daily risedronate
Hosking, D.; Adami, S.; Felsenberg, D. et al

in Osteoporosis International (2002), 13(S1), 18

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See detailSustained fracture risk reduction over 5 years with risedronate therapy
Watts, NB; Brown, J; Hosking, D et al

in Journal of Bone and Mineral Research (2001), 16(S1), 217

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See detailEffect of risedronate on the risk of hip fracture in elderly women
McClung, MR; Geusens, P; Miller, PD et al

in Clinical Rheumatology (2001), 20

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