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See detailRepublished: Value of biomarkers in osteoarthritis: current status and perspectives.
Lotz, M.; Martel-Pelletier, J.; Christiansen, C. et al

in Postgraduate Medical Journal (2014), 90(1061), 171-8

Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint ... [more ▼]

Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint remodelling and disease progression. This article was prepared following a working meeting of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis convened to discuss the value of biochemical markers of matrix metabolism in drug development in osteoarthritis. The best candidates are generally molecules or molecular fragments present in cartilage, bone or synovium and may be specific to one type of joint tissue or common to them all. Many currently investigated biomarkers are associated with collagen metabolism in cartilage or bone, or aggrecan metabolism in cartilage. Other biomarkers are related to non-collagenous proteins, inflammation and/or fibrosis. Biomarkers in osteoarthritis can be categorised using the burden of disease, investigative, prognostic, efficacy of intervention, diagnostic and safety classification. There are a number of promising candidates, notably urinary C-terminal telopeptide of collagen type II and serum cartilage oligomeric protein, although none is sufficiently discriminating to differentiate between individual patients and controls (diagnostic) or between patients with different disease severities (burden of disease), predict prognosis in individuals with or without osteoarthritis (prognostic) or perform so consistently that it could function as a surrogate outcome in clinical trials (efficacy of intervention). Future avenues for research include exploration of underlying mechanisms of disease and development of new biomarkers; technological development; the 'omics' (genomics, metabolomics, proteomics and lipidomics); design of aggregate scores combining a panel of biomarkers and/or imaging markers into single diagnostic algorithms; and investigation into the relationship between biomarkers and prognosis. [less ▲]

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See detailEfficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial.
Reginster, Jean-Yves ULg; Badurski, J; Bellamy, N et al

in Annals of the Rheumatic Diseases (2013), 72(2), 179-86

BACKGROUND: Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its ... [more ▼]

BACKGROUND: Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis. METHODS: Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5-5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372). RESULTS: The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: -0.23 (SD 0.56) mm; 2 g/day: -0.27 (SD 0.63) mm; placebo: -0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated. CONCLUSIONS: Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day. [less ▲]

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See detailValue of biomarkers in osteoarthritis: current status and perspectives.
Lotz, M.; Martel-Pelletier, J.; Christiansen, C. et al

in Annals of the Rheumatic Diseases (2013), 72

Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint ... [more ▼]

Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint remodelling and disease progression. This article was prepared following a working meeting of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis convened to discuss the value of biochemical markers of matrix metabolism in drug development in osteoarthritis. The best candidates are generally molecules or molecular fragments present in cartilage, bone or synovium and may be specific to one type of joint tissue or common to them all. Many currently investigated biomarkers are associated with collagen metabolism in cartilage or bone, or aggrecan metabolism in cartilage. Other biomarkers are related to non-collagenous proteins, inflammation and/or fibrosis. Biomarkers in osteoarthritis can be categorised using the burden of disease, investigative, prognostic, efficacy of intervention, diagnostic and safety classification. There are a number of promising candidates, notably urinary C-terminal telopeptide of collagen type II and serum cartilage oligomeric protein, although none is sufficiently discriminating to differentiate between individual patients and controls (diagnostic) or between patients with different disease severities (burden of disease), predict prognosis in individuals with or without osteoarthritis (prognostic) or perform so consistently that it could function as a surrogate outcome in clinical trials (efficacy of intervention). Future avenues for research include exploration of underlying mechanisms of disease and development of new biomarkers; technological development; the 'omics' (genomics, metabolomics, proteomics and lipidomics); design of aggregate scores combining a panel of biomarkers and/or imaging markers into single diagnostic algorithms; and investigation into the relationship between biomarkers and prognosis. [less ▲]

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See detailErratum to : Recommendations for the health economics analysis to be performed with a drug to be registered in prevention or treatment of osteoporosis
Dere, W; Avouac, B; Boers, M et al

in Calcified Tissue International (2013), 93

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See detailStrontium ranelate reduces the number of radiological or radioclinical progressors in patients with primary knee osteoarthritis
Reginster, Jean-Yves ULg; Chapurlat, R; Christiansen, C et al

in Osteoporosis International (2012, March), 23(S2), 366-367

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See detailStrontium ranelate in knee osteoarthritis trial (SEKOIA) : a structural and symptomatic efficacy
Reginster, Jean-Yves ULg; Chapurlat, R; Christiansen, C et al

in Arthritis and Rheumatism (2012), 64(S10), 681

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See detailEfficacy and safety of strontium ranelate in the treatment of knee osteoarthritis : a randomized, double-blind, placebo-controlled international trial
Cooper, C; Chapurlat, R; Christiansen, C et al

in Annals of the Rheumatic Diseases (2012), 71(3), 693

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See detailArzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women.
Cummings, S. R.; McClung, M.; Reginster, Jean-Yves ULg et al

in Journal of Bone and Mineral Research (2011), 26(2), 397-404

BACKGROUND: Arzoxifene is a selective estrogen receptor modulator (SERM) more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. METHODS: In a ... [more ▼]

BACKGROUND: Arzoxifene is a selective estrogen receptor modulator (SERM) more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. METHODS: In a randomized blinded trial, women age 60 to 85 years with osteoporosis, defined as a femoral neck or lumbar spine bone mineral density T-score less than or equal to -2.5 or a vertebral fracture, and women with low bone mass, defined as a bone density T-score less than or equal to -1.0 and above -2.5, were assigned to arzoxifene 20 mg or placebo daily. The primary endpoints were new vertebral fracture in those with osteoporosis, and invasive breast cancer in the overall population. RESULTS: After 3 years, the cumulative incidence of vertebral fractures in patients with osteoporosis was 2.3% lower in the arzoxifene than in the placebo group, a 41% relative risk reduction (95% CI 0.45 to 0.77; P<0.001). In the overall population, the cumulative incidence of invasive breast cancer over 4 years was reduced by 1.3%, with a 56% relative reduction in risk (HR=0.44; 95% CI 0.26 to 0.76; P<0.001); there was no significant decrease in nonvertebral fracture risk. Arzoxifene increased the cumulative incidence of venous thromboembolic events by 0.7%, with a 2.3-fold relative increase (95% CI 1.5 to 3.7). CONCLUSION: Like other SERMs, arzoxifene decreased vertebral fractures and invasive breast cancer while the risk of venous thromboembolic events increased. (c) 2010 American Society for Bone and Mineral Research. [less ▲]

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See detailEfficacy and safety of strontium ranelate in the treatment of knee ostoarthritis : a randomized, double-blind, placebo-controlled international trial
Reginster, Jean-Yves ULg; Chapurlat, R.; Christiansen, C. et al

in Osteoporosis International (2011), 22(S5), 742-743

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See detailEffects of arzoxifene on fracture incidence in postmenopausal women with osteoporosis or with low bone mass
Reginster, Jean-Yves ULg; McClung, M.; Cox, D. et al

in Osteoporosis International (2010, May), 21(Suppl.1), 23-24

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See detailAssociation between spinal osteoarthritis and biochemical markers of bone and cartilage remodelling
Bruyère, Olivier ULg; Collette, Julien ULg; Christiansen, C. et al

in Osteoporosis International (2008, April), 19(Suppl.1), 200

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See detailStrontium ranelate reduces the urinary level of cartilage degradation biomarker CTX-II in postmenopausal women
Alexandersen, P.; Karsdal, M. A.; Qvist, P. et al

in BONE (2007), 40(1), 218-222

Objective: Strontium ranelate significantly decreases the risk of osteoporotic fractures. The objective of the present study was to investigate whether strontium ranclate (2 g/day) also affects cartilage ... [more ▼]

Objective: Strontium ranelate significantly decreases the risk of osteoporotic fractures. The objective of the present study was to investigate whether strontium ranclate (2 g/day) also affects cartilage brakedown as measured by urinary marker of cartilage degradation, designated CTX-II. Methods: A subgroup of 2617 postmenopausal osteoporotic women (aged 75.7 +/- 4.4 years) were selected from the TROPOS phase III study on the basis of a urinary sampling reported at each visit during the first three years of the study. When included in TROPOS, they were randomized to strontium ranelate or placebo in a double-blind fashion for 3 years. A calcium and vitamin D supplement was also provided to the subjects during the study. A marker of collagen type II degradation (CTX-II) corrected for urinary creatinine (CTX-II/cr.) was assessed at regular intervals throughout the study in 1310 patients in strontium ranelate group and 1307 patients in placebo group. Results: The response in CTX-II depended on time (p < 0.0001), and this time dependency differed statistically significantly between groups (time x treatment) (p < 0.0003). In addition, there was a statistically significant difference between treatments (p < 0.0001). The difference in the response of CTX-II/cr. appeared already after three months, with the strontium ranelate-treated subjects having approximately 15-20% lower values than the placebo-treated subjects for the remaining study period (p < 0.0001). Conclusion: Treatment with strontium ranelate significantly decreases urinary excretion of CTX-II, a marker of cartilage destruction. Further studies are warranted to investigate an effect on cartilage formation and symptoms of osteoarthritis. (c) 2006 Elsevier Inc. All rights reserved. [less ▲]

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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 inhibits urinary excretion of CTX-II, a marker of cartilage degradation, in postmenopausal women
Alexandersen, P.; Tanko, L. B.; Bagger, Y. Z. et al

in Osteoporosis International (2005, March), 16(suppl.3), 60

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See detailSafety and efficacy of a novel salmon calcitonin (sCT) technology-based oral formulation in healthy postmenopausal women: Acute and 3-month effects on biomarkers of bone turnover
Tanko, L. B.; Bagger, Y. Z.; Alexandersen, P. et al

in Journal of Bone and Mineral Research (2004), 19(9), 1531-1538

Oral administration of calcitonin could improve compliance to long-term treatment. Efficacy and safety of a novel oral formulation was assessed on 277 postmenopausal women. The results show (1) effective ... [more ▼]

Oral administration of calcitonin could improve compliance to long-term treatment. Efficacy and safety of a novel oral formulation was assessed on 277 postmenopausal women. The results show (1) effective enteral absorption, (2) marked inhibition of bone resorption with minimal alteration of formation, and (3) reproducibility of responses over 3 months. Introduction: We have recently introduced an Eligen technology-based oral formulation of salmon calcitonin (sCT) that effectively delivers the hormone to the circulation. The efficacy and safety during longer-term administration, however. has not been investigated in the target population. Materials and Methods: This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age. Women received treatment with either daily (0.15, 0.4. 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months. All participants received 1000 mg calcium plus 400 IU vitarnin D daily throughout the study. Efficacy parameters were the acute and/or pre-dose changes in serum and urinary C-terminal telopeptide of type I collagen (CTx), N-mid osteocalcin (OC), bone-specific alkaline phosphatase (BSALP), calcium, and parathyroid hormone (PTH) measured by established immunoassays. Results: After the first dose, sCT evoked dose-dependent decreases in serum CTx (-60.8% to -81.8% from baseline) compared with placebo, reaching nadirs 2-3 h after drug intake, after which, gradual increases were observed. The simultaneous acute changes in OC were statistically nonsignificant. Area under the curve (AUC) of serum CTx responses at months 1 and 3 showed strong correlation with those at baseline (both r = 0.78, p < 0.001). At month 3. the placebo-corrected changes in the pre-dose value of serum and urinary CTx were significant only in the 1.0-mg dose group (-18.9% and -20.5%, respectively, p < 0.05). The placebo-corrected change in OC was - 8.6 (p = 0.09), whereas the change in BSALP was -7.3 (p = 0.02). The oral formulation was well tolerated, with mild to moderate gastrointestinal and skin manifestations apparent mainly in the high-dose groups. Conclusion: The results of this 3-month trial show that the novel Eligen technology-based oral formulation of sCT has potential to become a safe and effective treatment for postmenopausal bone loss. Future trials are needed to assess the impact of long-term administration on changes in BMD and fracture risk. [less ▲]

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See detailOnce-monthly oral ibandronate a new bisphosphonate dosing concept
Reginster, Jean-Yves ULg; Miller, P.; Delmas, P. et al

in Calcified Tissue International (2004), 74(S1), 85

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See detailUncoupling of bone formation and resorption with a novel oral formulation of salmon calcitonin in postmenopausal women
Tanko, L. B.; Bagger, Y. Z.; Devogelaer, Jean-Pierre et al

in Osteoporosis International (2003, November), 14(Suppl. 7), 4

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See detailIpriflavone in the treatment of postmenopausal osteoporosis: a randomized controlled trial.
Alexandersen, P; Toussaint, André ULg; Christiansen, C et al

in JAMA : Journal of the American Medical Association (2001), 285(11), 1482-8

CONTEXT: Data on the efficacy and safety of ipriflavone for prevention of postmenopausal bone loss are conflicting. OBJECTIVES: To investigate the effect of oral ipriflavone on prevention of ... [more ▼]

CONTEXT: Data on the efficacy and safety of ipriflavone for prevention of postmenopausal bone loss are conflicting. OBJECTIVES: To investigate the effect of oral ipriflavone on prevention of postmenopausal bone loss and to assess the safety profile of long-term treatment with ipriflavone in postmenopausal osteoporotic women. DESIGN AND SETTING: Prospective, randomized, double-blind, placebo-controlled, 4-year study conducted in 4 centers in Belgium, Denmark, and Italy from August 1994 to July 1998. PARTICIPANTS: Four hundred seventy-four postmenopausal white women, aged 45 to 75 years, with bone mineral densities (BMDs) of less than 0.86 g/cm(2). INTERVENTIONS: Patients were randomly assigned to receive ipriflavone, 200 mg 3 times per day (n = 234), or placebo (n = 240); all received 500 mg/d of calcium. MAIN OUTCOME MEASURES: Efficacy measures included spine, hip, and forearm BMD and biochemical markers of bone resorption (urinary hydroxyproline corrected for creatinine and urinary CrossLaps [Osteometer Biotech, Herlev, Denmark] corrected for creatinine), assessed every 6 months. Laboratory safety measures and adverse events were recorded every 3 months. RESULTS: Based on intent-to-treat analysis, after 36 months of treatment, the annual percentage change from baseline in BMD of the lumbar spine for ipriflavone vs placebo (0.1% [95% confidence interval (CI), -7.9% to 8.1%] vs 0.8% [95% CI, -9.1% to 10.7%]; P =.14), or in any of the other sites measured, did not differ significantly between groups. The response in biochemical markers was also similar between groups (eg, for hydroxyproline corrected for creatinine, 20.13 mg/g [95% CI, 18.85-21.41 mg/g] vs 20.67 mg/g [95% CI, 19.41-21.92 mg/g]; P =.96); urinary CrossLaps corrected for creatinine, 268 mg/mol (95% CI, 249-288 mg/mol) vs 268 mg/mol (95% CI, 254-282 mg/mol); P =.81. The number of women with new vertebral fracture was identical or nearly so in the 2 groups at all time points. Lymphocyte concentrations decreased significantly (500/microL (0.5 x 10(9)/L]) in women treated with ipriflavone. Thirty-one women (13.2%) in the ipriflavone group developed subclinical lymphocytopenia, of whom 29 developed it during ipriflavone treatment. Of these, 15 (52%) of 29 had recovered spontaneously by 1 year and 22 (81%) of 29 by 2 years. CONCLUSIONS: Our data indicate that ipriflavone does not prevent bone loss or affect biochemical markers of bone metabolism. Additionally, ipriflavone induces lymphocytopenia in a significant number of women. [less ▲]

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