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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 detailLong-term efficacy of risedronate: a 5-year placebo-controlled clinical experience
Sorensen, O. H.; Crawford, G. M.; Mulder, H. et al

in BONE (2003), 32(2), 120-126

Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year ... [more ▼]

Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year, placebo-controlled vertebral fracture study in osteoporotic women for an additional 2 years; women who entered the extension study continued to receive 5 mg risedronate or placebo according to the original randomization, with maintenance of blinding. End points included vertebral and nonvertebral fracture assessments, bone mineral density measurements, and changes in biochemical markers of bone turnover. A total of 265 women (placebo, 130; 5 mg risedronate, 135) entered the study extension and 220 (83%) completed the additional 2 years. Fracture results observed in the study extension were consistent with those observed in the first 3 years. The risk of new vertebral fractures was significantly reduced with risedronate treatment in years 4 and 5 by 59% (95% confidence interval, 19 to 79%, P = 0.01) compared with a 49% reduction in the first 3 years. Rapid and significant decreases in markers of bone turnover observed in the first 3 years were similarly maintained in the next 2 years of treatment. Increases in spine and hip bone mineral density that occurred in the risedronate group during the first 3 years were maintained or increased with a further 2 years of treatment. The mean increase from baseline in lumbar spine BMD over 5 years was 9.3% (P < 0.001). This study demonstrates that the effects of risedronate over 3 years on vertebral fracture and BMD are maintained with a further 2 years of treatment. (C) 2003 Elsevier Science (USA). All rights reserved. [less ▲]

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See detailEfficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: Four-year results from a randomized clinical trial
Delmas, P. D.; Ensrud, K. E.; Adachi, J. D. et al

in Journal of Clinical Endocrinology and Metabolism (2002), 87(8), 3609-3617

The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999):6371. This report assesses the ... [more ▼]

The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999):6371. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.761 with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43,0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr. [less ▲]

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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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See detailGenetic markers of osteoarticular disorders: facts and hopes.
Brandi, M L; Gennari, L; Cerinic, M M et al

in Arthritis Research (2001), 3(5), 270-80

Osteoarthritis and osteoporosis are the two most common age-related chronic disorders of articular joints and skeleton, representing a major public health problem in most developed countries. Apart from ... [more ▼]

Osteoarthritis and osteoporosis are the two most common age-related chronic disorders of articular joints and skeleton, representing a major public health problem in most developed countries. Apart from being influenced by environmental factors, both disorders have a strong genetic component, and there is now considerable evidence from large population studies that these two disorders are inversely related. Thus, an accurate analysis of the genetic component of one of these two multifactorial diseases may provide data of interest for the other. However, the existence of confounding factors must always be borne in mind in interpreting the genetic analysis. In addition, each patient must be given an accurate clinical evaluation, including family history, history of drug treatments, lifestyle, and environment, in order to reduce the background bias. Here, we review the impact of recent work in molecular genetics suggesting that powerful molecular biology techniques will soon make possible both a rapid accumulation of data on the genetics of both disorders and the development of novel diagnostic, prognostic, and therapeutic approaches. [less ▲]

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See detailDo estrogens effectively prevent osteoporosis-related fractures?
Reginster, Jean-Yves ULg; Bruyère, Olivier ULg; Audan, M. et al

in Calcified Tissue International (2000), 67

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See detailEffects of raloxifene on bone mineral density and biochemical markers of bone turnover in postmenopausal women with osteoporosis : 4-year results from the MORE trial
Delmas, PD; Ensrud, KE; Harper, K et al

in Journal of Bone and Mineral Research (2000), 15(S1), 556

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See detailThe effects of raloxifene on incident vertebral fractures in postmenopausal women with osteoporosis : 4-year results from the MORE trial
Eastell, R; Adachi, J; Harper, K et al

in Journal of Bone and Mineral Research (2000), 15(S1), 229

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See detailIpriflavone has no effect on bone metabolism and causes lymphopenia in osteopenic women
Alexandersen, P; Toussaint, A; Reginster, Jean-Yves ULg et al

in Journal of Bone and Mineral Research (2000), 15(S1), 198

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See detailFailure of ipriflavone to significantly reduce vertebral fracture rates and to increase bone mineral density in postmenopausal osteoporosis : the IMEFS study
Reginster, Jean-Yves ULg; Alexandersen, P; Devogelaer, JP et al

in Arthritis and Rheumatism (2000), 43(S1), 1898

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See detailAssociation of Tibolone and Fluoride Displays a Pronounced Effect on Bone Mineral Density in Postmenopausal Osteoporotic Women
Reginster, Jean-Yves ULg; Agnusdei, D.; Gennari, C. et al

in Gynecological Endocrinology : The Official Journal of the International Society of Gynecological Endocrinology (1999), 13(5), 361-8

A double-blind, placebo-controlled, randomized, prospective two-center study was carried out to assess the effects of tibolone + fluoride versus placebo + fluoride therapy on trabecular and cortical bone ... [more ▼]

A double-blind, placebo-controlled, randomized, prospective two-center study was carried out to assess the effects of tibolone + fluoride versus placebo + fluoride therapy on trabecular and cortical bone in postmenopausal osteoporotic women. Ninety-four subjects (mean age 61.1 years, postmenopausal 13.5 years on average) with low bone mineral density (BMD) at baseline were randomized to 2.5 mg of tibolone (Org OD 14, Livial) plus 26.4 mg of fluoride (Fluocalcic) or placebo plus 26.4 mg of fluoride daily over 2 years; 55 (58.5%) subjects completed the study, the main reason for discontinuation being untoward gastrointestinal effects. BMD at the lumbar spine was measured by both dual photon absorptiometry (DPA) and dual-energy X-ray absorptiometry (DXA), and at the hip by DXA at 6-month intervals. Baseline values (DXA, g/cm2) for tibolone + fluoride and placebo + fluoride groups were 0.733 and 0.744 for the lumbar spine, and 0.761 and 0.788 for the hip. Change from baseline and percentage change from baseline were calculated for the intent-to-treat and completers groups. An analysis of variance (ANOVA) model or Wilcoxon test was used for statistical evaluation. There was a mean increase in BMD at the lumbar spine measured by DPA of 25.3% and 12.3% in tibolone + fluoride and placebo + fluoride groups, respectively (p = 0.01); with DXA, respective changes were 32.6% and 14.0% (p = 0.013). Data on BMD at the hip showed mean increases of 7.9% and 2.6% for the tibolone + fluoride and placebo + fluoride groups, respectively. We conclude that combined tibolone + fluoride treatment induces a highly significant increase in BMD at the lumbar spine without simultaneous loss of the cortical bone allowing for a meaningful reduction of the fluoride dose when given in combination with tibolone. [less ▲]

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See detailRaloxifene therapy for 3 years reduces the risk of incident vertebral fractures in postmenopausal women
Delmas, PD; Ensrud, KE; Harris, S et al

in Calcified Tissue International (1999), 64(S1), 43

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See detailThe effect of 2 and 3 years of Raloxifene on vertebral and non-vertebral fractures in postmenopausal women with osteoporosis
Ensrud, K; Black, D; Recker, R et al

in BONE (1998), 23(S5), 174

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See detailPoints to consider for the development of new indications for hormone replacement therapies and estrogen-like molecules
Stevenson, JC; GASPARD, Ulysse ULg; Avouac, B et al

in Climacteric : The Journal of the International Menopause Society (1998), 1

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See detailBisphosphonates and osteoporosis treatment in Italy
Gennari, C; Reginster, Jean-Yves ULg

in Aging Clinical & Experimental Research (1998), 10

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See detailRecommendations for the health economic 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 (1998), 63

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See detailPour l’optimisation de la stratégie thérapeutique dans la maladie osseuse de Paget
Reginster, Jean-Yves ULg; Gennari, C; Hosking, DJ et al

in Revue du Rhumatisme (1997), 64(4), 221-223

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See detailOptimizing the treatment of Paget’s disease of bone
Reginster, Jean-Yves ULg; Gennari, C; Hosking, DJ et al

in Revue du Rhumatisme (English ed.) (1997), 64(4), 207-209

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See detailDesign for an Ipriflavone Multicenter European Fracture Study
Reginster, Jean-Yves ULg; Bufalino, L.; Christiansen, C. et al

in Calcified Tissue International (1997), 61(Suppl 1), 28-32

In order to investigate the efficacy of ipriflavone (i.p.) on the prevention of vertebral fractures and the effect on bone mineral density (BMD) in women with postmenopausal osteoporosis, a large ... [more ▼]

In order to investigate the efficacy of ipriflavone (i.p.) on the prevention of vertebral fractures and the effect on bone mineral density (BMD) in women with postmenopausal osteoporosis, a large multicentric European study was designed and is presently ongoing. Included in the study were 460 Caucasian, nonobese postmenopausal women aged > 45 and < 75 years, menopaused for at least 12 months. Inclusion was on the basis of a lumbar bone mineral density (BMD) lower than 2 SD compared with healthy women aged 50 years, corresponding to values below 0.860 g/cm2 (antero-posterior measurement) by Hologic QDR 1000. Women with prevalent vertebral fractures were excluded as well as those presenting secondary osteoporosis or having been treated with medications that could affect bone metabolism. This study was designed as a 3-year, double-blind, placebo-controlled, parallel group study that randomized the women to the oral administration of either 3 x 200 mg/day of i.p. or placebo. All patients received a daily supplement of 500 mg calcium. The primary purpose of the study was to evaluate the efficacy of i.p. in preventing vertebral nontraumatic fractures. Fracture is defined here as a > or = 20% decrease in any anterior, central, or posterior T4-L4 vertebral height. Blinded vertebral X-ray readings and vertebral morphometry have been centralized in an independent Center, with standardized evaluation of two experts. Power calculations have been based on the hypothesis that 21% of placebo-treated patients would fracture within 3 years and that treatment with i.p. would lead to a 50% reduction in the incidence of fracture. Statistical tests have been designed to have a power of 80%, with a type I error equal to 5%. Secondary endpoints were changes in vertebral, radial, and femoral BMD. Centralized controls on 100% BMD scans would ensure the good quality of BMD readings. This study should verify the hypothesis that i.p. significantly decreases the risk of vertebral fracture in postmenopausal, osteoporotic women. [less ▲]

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