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See detailMarkers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards
Vasikaran, S.; Eastell, R.; Bruyère, Olivier ULg et al

in Osteoporosis International (2011), 22

Summary The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend that a marker of bone formation (serum procollagen ... [more ▼]

Summary The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend that a marker of bone formation (serum procollagen type I N propeptide, s-PINP) and a marker of bone resorption (serum C-terminal telopeptide of type I collagen, s-CTX) are used as reference analytes for bone turnover markers in clinical studies. Introduction Bone turnover markers (BTM) predict fracture risk, and treatment-induced changes in specific markers account for a substantial proportion of fracture risk reduction. The aims of this report were to determine their clinical potential in the prediction of fracture risk and for monitoring the treatment of osteoporosis and to set an appropriate research agenda. Methods Evidence from prospective studies was gathered through literature review of the PUBMED database between the years 2000 and 2010 and the systematic review of the Agency for Healthcare Research and Quality up to 2001. Results High levels of BTMs may predict fracture risk independently from bone mineral density in postmenopausal women. They have been used for this purpose in clinical practice for many years, but there is still a need for stronger evidence on which to base practice. BTMs provide pharmacodynamic information on the response to osteoporosis treatment, and as a result, they are widely used for monitoring treatment in the individual. However, their clinical value for monitoring is limited by inadequate appreciation of the sources of variability, by limited data for comparison of treatments using the same BTM and by inadequate quality control. IOF/IFCC recommend one bone formation marker (s-PINP) and one bone resorption marker (s-CTX) to be used as reference markers and measured by standardised assays in observational and intervention studies in order to compare the performance of alternatives and to enlarge the international experience of the application of markers to clinical medicine. Conclusion BTM hold promise in fracture risk prediction and for monitoring treatment. Uncertainties over their clinical use can be in part resolved by adopting international reference standards. [less ▲]

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See detailDevelopment of an algorithm for using PINP to monitor treatment of patients with teriparatide
Eastell, R.; Krege, J. H.; Chen, P. Q. et al

in Current Medical Research & Opinion (2006), 22(1), 61-66

Introduction: Teriparatide effects are mediated via the preferential stimulation of osteoblastic activity over osteoclastic activity. Amino-terminal propeptide of type I procollagen (PINP) is an indicator ... [more ▼]

Introduction: Teriparatide effects are mediated via the preferential stimulation of osteoblastic activity over osteoclastic activity. Amino-terminal propeptide of type I procollagen (PINP) is an indicator of osteoblastic activity. Objective: Develop an algorithm using PINP as an aid in the management of patients with postmenopausal osteoporosis treated with teriparatide. Research design and methods: For inclusion in this post-hoc analysis, trials had to be investigations of teriparatide 20 mu g/day in postmenopausal women with osteoporosis having measurements of PINP at 3 months and bone mineral density (BMD) at 12 months. Signal-to-noise ratio was calculated for a series of markers of bone turnover in the Fracture Prevention Trial. An algorithm was developed to monitor patients treated with teriparatide using PINP. Results:Three trials met inclusion criteria and included the Fracture Prevention, Forteo-Alendronate Comparator and Anabolic After Antiresorptive trials. PINP had the highest signal-to-noise ratio of all bone-turnover markers. Positive PINP responses defined as increases > 10 mu g/L were observed in 77-97% of teriparatide- and in 6% of placebo-treated patients after 3 months of study drug. Mean lumbar spine BMD increases after 12 months of teriparatide in patients having PINP changes > 10 mu g/L ranged from 8.3% to 9.5% and in patients with PINP changes <= 10 mu g/L ranged from 5.9% to 7.6%. In the algorithm, PINP is measured at baseline and after 1-3 months of therapy. Patients with PINP increases > 10 mu g/L are given a positive message. Patients with PINP increases <= 10 mu g/L are assessed for adherence, teriparatide administration and storage techniques, and for the presence of medical conditions that might limit their therapeutic response, and these issues are addressed as appropriate. Patients without these issues and with PINP increases <= 10 mu g/L should be given a neutral message because BMD may significantly increase with continued therapy. Conclusions: The PINP algorithm provides information regarding the anabolic response to teriparatide therapy and has the potential to identify patients requiring help with issues of adherence, injection technique, teriparatide storage, and medical problems limiting therapeutic responsiveness to teriparatide treatment, Data assessing the relationship of changes in PINP to fracture risk reduction are not available. We recommend physicians audit the use of the algorithm in practice so that improvements can be made. [less ▲]

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See detailIdentification of responders to teriparatide therapy by procollagen Type I N-Propeptide (P1NP) using the least significant change approach
Eastell, R.; Chen, P.; Krege, J. H. et al

in Osteoporosis International (2005, March), 16(Suppl.3), 5

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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 detailEffect of High Doses of Oral Risedronate (20 Mg/Day) on Serum Parathyroid Hormone Levels and Urinary Collagen Cross-Link Excretion in Postmenopausal Women with Spinal Osteoporosis
Zegels, Brigitte ULg; Eastell, R.; Russell, R. G. et al

in BONE (2001), 28(1), 108-12

The present study describes the biological effects of risedronate, a pyridinyl bisphosphonate, on bone and assesses the safety and tolerability of risedronate when given at high doses, with or without ... [more ▼]

The present study describes the biological effects of risedronate, a pyridinyl bisphosphonate, on bone and assesses the safety and tolerability of risedronate when given at high doses, with or without calcium, to postmenopausal women with spinal osteoporosis. This single-center descriptive, double-blind, placebo-controlled, randomized, parallel group study included 32 postmenopausal white women with at least one radiographically confirmed vertebral compression fracture. Patients were randomized to one of four different dose regimen groups: (i) R-P, risedronate 20 mg/day for 14 days, followed by placebo for 42 days; (ii) R-CP-P, risedronate 20 mg/day for 14 days, followed by elemental calcium 1000 mg/day and placebo for 14 days, then by placebo for 28 days; (iii) R-CP-R-CP, risedronate 20 mg/day for 7 days, followed by elemental calcium 1000 mg/day and placebo for 21 days, then risedronate 20 mg/day for 7 days, and finally elemental calcium 1000 mg/day and placebo for 21 days; and (iv) P, placebo for 56 days. The biological response was investigated by measuring serum calcium, parathyroid hormone (PTH), and 2 h urinary pyridinoline/creatinine (Pyr/Cr) and deoxypyridinoline/creatinine (DPyr/Cr) ratios at baseline and at days 3, 7, 14, 21, 28, 35, 42, 49, 56, and 84. Overall, there were no consistent trends observed between the active group and placebo for serum calcium. In groups R-P, R-CP-P, and R-CP-R-CP, mean serum PTH levels were elevated above baseline values for the entire 56 day treatment period and remained elevated, although to a lesser extent, at the day 84 follow-up visit. The effect of calcium supplementation on PTH was variable. Urinary Pyr/Cr and DPyr/Cr ratios were decreased from baseline over the entire study period in all groups receiving risedronate. The maximum observed percent decreases from baseline for Pyr/Cr and DPyr/Cr were -46.9% and -58.8%, respectively, at day 49 in the R-CP-R-CP group. In conclusion, risedronate given orally at a dose of 20 mg/day, continuously for 7 or 14 days, resulted in the expected biological response in osteoporotic women. The time course of changes in PTH levels following cessation of dosing was unaffected by calcium supplementation. There was no evidence of a PTH-mediated rebound in bone resorption following cessation of therapy. Furthermore, based on collagen cross-link data, patients did not show an excessive reduction in bone turnover. [less ▲]

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See detailThe effect of risedronate on hip fracture risk in elderly women with osteoporosis
Bensen, W; Eastell, R; Reginster, Jean-Yves ULg et al

in Journal of Rheumatology (2001), 28(S63), 24

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See detailEfficacy of risedronate in decreasing the incidence of femoral neck and intertrochanteric fractures in older women with osteoporosis
Eastell, R; McClung, MR; Reginster, Jean-Yves ULg et al

in Journal of Bone and Mineral Research (2001), 16(S1), 219

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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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See detailEffect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group.
McClung, M R; Geusens, P; Miller, P D et al

in New England Journal of Medicine [=NEJM] (2001), 344(5), 333-40

BACKGROUND: Risedronate increases bone mineral density in elderly women, but whether it prevents hip fracture is not known. METHODS: We studied 5445 women 70 to 79 years old who had osteoporosis ... [more ▼]

BACKGROUND: Risedronate increases bone mineral density in elderly women, but whether it prevents hip fracture is not known. METHODS: We studied 5445 women 70 to 79 years old who had osteoporosis (indicated by a T score for bone mineral density at the femoral neck that was more than 4 SD below the mean peak value in young adults [-4] or lower than -3 plus a nonskeletal risk factor for hip fracture, such as poor gait or a propensity to fall) and 3886 women at least 80 years old who had at least one nonskeletal risk factor for hip fracture or low bone mineral density at the femoral neck (T score, lower than -4 or lower than -3 plus a hip-axis length of 11.1 cm or greater). The women were randomly assigned to receive treatment with oral risedronate (2.5 or 5.0 mg daily) or placebo for three years. The primary end point was the occurrence of hip fracture. RESULTS: Overall, the incidence of hip fracture among all the women assigned to risedronate was 2.8 percent, as compared with 3.9 percent among those assigned to placebo (relative risk, 0.7; 95 percent confidence interval, 0.6 to 0.9; P=0.02). In the group of women with osteoporosis (those 70 to 79 years old), the incidence of hip fracture among those assigned to risedronate was 1.9 percent, as compared with 3.2 percent among those assigned to placebo (relative risk, 0.6; 95 percent confidence interval, 0.4 to 0.9; P=0.009). In the group of women selected primarily on the basis of nonskeletal risk factors (those at least 80 years of age), the incidence of hip fracture was 4.2 percent among those assigned to risedronate and 5.1 percent among those assigned to placebo (P=0.35). CONCLUSIONS: Risedronate significantly reduces the risk of hip fracture among elderly women with confirmed osteoporosis but not among elderly women selected primarily on the basis of risk factors other than low bone mineral density. [less ▲]

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See detailRandomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group.
REGINSTER, Jean-Yves ULg; Minne, H. W.; Sorensen, O. H. et al

in Osteoporosis International (2000), 11(1), 83-91

The purpose of this randomized, double-masked, placebo-controlled study was to determine the efficacy and safety of risedronate in the prevention of vertebral fractures in postmenopausal women with ... [more ▼]

The purpose of this randomized, double-masked, placebo-controlled study was to determine the efficacy and safety of risedronate in the prevention of vertebral fractures in postmenopausal women with established osteoporosis. The study was conducted at 80 study centers in Europe and Australia. Postmenopausal women (n = 1226) with two or more prevalent vertebral fractures received risedronate 2.5 or 5 mg/day or placebo; all subjects also received elemental calcium 1000 mg/day, and up to 500 IU/day vitamin D if baseline levels were low. The study duration was 3 years; however, the 2.5 mg group was discontinued by protocol amendment after 2 years. Lateral spinal radiographs were taken annually for assessment of vertebral fractures, and bone mineral density was measured by dual-energy X-ray absorptiometry at 6-month intervals. Risedronate 5 mg reduced the risk of new vertebral fractures by 49% over 3 years compared with control (p<0.001). A significant reduction of 61% was seen within the first year (p = 0.001). The fracture reduction with risedronate 2.5 mg was similar to that in the 5 mg group over 2 years. The risk of nonvertebral fractures was reduced by 33% compared with control over 3 years (p = 0.06). Risedronate significantly increased bone mineral density at the spine and hip within 6 months. The adverse-event profile of risedronate, including gastrointestinal adverse events, was similar to that of control. Risedronate 5 mg provides effective and well-tolerated therapy for severe postmenopausal osteoporosis, reducing the incidence of vertebral fractures and improving bone density in women with established disease. [less ▲]

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See detailRisedronate reduces hip fracture risk in elderly women with osteoporosis
McClung, M; Eastell, R; Bensen, W et al

in Osteoporosis International (2000), 11(S2), 207

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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 detailRisedronate significantly reduces vertebral and non-vertebral fractures in osteoporotic women
Roux, C; Keller, M; Eastell, R et al

in Journal of Bone and Mineral Research (1999), 14(S1), 538

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See detailRisedronate is well-tolerated in women with osteoporosis
McClung, M; Eastell, R; Watts, N et al

in Journal of Bone and Mineral Research (1999), 14(S1), 538

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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 detailRisedronate reduces fracture risk in women with established postmenopausal osteoporosis
Eastell, R; Minne, H; Sorensen, O et al

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

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See detailRisedronate reduces hip fractures in patients with low femoral neck bone mineral density
Miller, P; Roux, C; McClung, M et al

in Arthritis and Rheumatism (1999), 42(S1), 287

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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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