References of "Calcified Tissue International"
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See detailChallenges for the Development of Bone-Forming Agents in Europe.
Kanis, John A.; Rizzoli, Rene; Cooper, Cyrus et al

in Calcified tissue international (2014), 94

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See detailVitamin D status and bone mineral density changes during alendronate treatment in postmenopausal osteoporosis.
Roux, Christian; Binkley, Neil; Boonen, Steven et al

in Calcified tissue international (2014), 94(2), 153-7

Vitamin D supplementation is recommended for women with osteoporosis. In the FOCUS-D trial comparing the combination tablet alendronate plus vitamin D3 5,600 IU (ALN/D) with standard care (SC) prescribed ... [more ▼]

Vitamin D supplementation is recommended for women with osteoporosis. In the FOCUS-D trial comparing the combination tablet alendronate plus vitamin D3 5,600 IU (ALN/D) with standard care (SC) prescribed by patients' personal physicians, ALN/D was more effective in improving serum 25(OH)D and bone turnover markers by 6 months and increasing spine and hip bone mineral density (BMD) after 1 year than SC. This post hoc analysis examined the relationship between BMD gain and 25(OH)D in women in SC receiving alendronate (SC/ALN, n = 134, 52% of the SC group) and in the ALN/D group (n = 257). At baseline, participants were of mean age 73 years and 72% were Caucasian, with a mean 25(OH)D of 14.9 ng/mL. In the SC/ALN group, most received vitamin D, although intake of vitamin D varied extensively (51% received <400 mug/day). In this group, end-of-study 25(OH)D correlated positively with mean percent increases from baseline in lumbar spine and femoral neck BMD [Pearson correlation coefficients (95% CI) = 0.23 (0.02-0.41) and 0.24 (0.03-0.41), respectively]. Baseline 25(OH)D correlated with increases in only lumbar spine BMD [Pearson correlation coefficient (95% CI) = 0.22 (0.01-0.40)]. No correlations between mean BMD change and 25(OH)D were seen with ALN/D. In conclusion, in postmenopausal women with osteoporosis and low 25(OH)D receiving alendronate and a wide range of vitamin D doses, the increase in lumbar spine and femoral neck BMD was positively correlated with serum 25(OH)D achieved by the end of the study and, to some extent, with 25(OH)D concentrations at baseline. The degree of success of alendronate therapy for osteoporosis may depend on the vitamin D status of patients. [less ▲]

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See detailTeriparatide Therapy for Denosumab-Induced Osteonecrosis of the Jaw in a Male Osteoporotic Patient.
Neuprez, Audrey; Rompen, Eric ULg; Crielaard, Jean-Michel ULg et al

in Calcified tissue international (2014), 95

We report the first case of teriparatide adjuvant role in the management of a denosumab-induced osteonecrosis of the jaw in a male subject with idiopathic osteoporosis. Clinical benefits and CT healing ... [more ▼]

We report the first case of teriparatide adjuvant role in the management of a denosumab-induced osteonecrosis of the jaw in a male subject with idiopathic osteoporosis. Clinical benefits and CT healing were obtained within 2 months of teriparatide initiation and denosumab withdrawal. Increase in bone turnover previously described, when denosumab treatment is removed, might have a synergistic effect to the stimulating effect of teriparatide on bone remodeling to promptly heal osteonecrosis of the jaw. [less ▲]

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See detailQuality of life in sarcopenia and frailty
Rizzoli, René; Reginster, Jean-Yves ULg; Arnal, Jean-François et al

in Calcified Tissue International (2013), 93

The reduced muscle mass and impaired muscle performance that define sarcopenia in older individuals are associated with increased risk of physical limitation and a variety of chronic diseases. They may ... [more ▼]

The reduced muscle mass and impaired muscle performance that define sarcopenia in older individuals are associated with increased risk of physical limitation and a variety of chronic diseases. They may also contribute to clinical frailty. A gradual erosion of quality of life (QoL) has been evidenced in these individuals, although much of this research has been done using generic QoL instruments, particularly the SF-36, which may not be ideal in older populations with significant comorbidities. This review and report of an expert meeting presents the current definitions of these geriatric syndromes (sarcopenia and frailty). It then briefly summarizes QoL concepts and specificities in older populations and examines the relevant domains of QoL and what is known concerning QoL decline with these conditions. It calls for a clearer definition of the construct of disability, argues that a disease-specific QoL instrumentfor sarcopenia/frailty would be an asset for future research, and discusses whether there are available and validated components that could be used to this end and whether the psychometric properties of these instruments are sufficiently tested. It calls also for an approach using utility weighting to provide some cost estimates and suggests that a time trade-off study could be appropriate. [less ▲]

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See detailHealth Technology Assessment in Osteoporosis.
Hiligsmann, Mickaël ULg; Kanis, John A.; Compston, Juliet et al

in Calcified Tissue International (2013)

We review the various aspects of health technology assessment in osteoporosis, including epidemiology and burden of disease, and assessment of the cost-effectiveness of recent advances in the treatment of ... [more ▼]

We review the various aspects of health technology assessment in osteoporosis, including epidemiology and burden of disease, and assessment of the cost-effectiveness of recent advances in the treatment of osteoporosis and the prevention of fracture, in the context of the allocation of health-care resources by decision makers in osteoporosis. This article was prepared on the basis of a symposium held by the Belgian Bone Club and the discussions surrounding that meeting and is based on a review and critical appraisal of the literature. Epidemiological studies confirm the immense burden of osteoporotic fractures for patients and society, with lifetime risks of any fracture of the hip, spine, and forearm of around 40 % for women and 13 % for men. The economic impact is also large; for example, Europe's six largest countries spent <euro>31 billion on osteoporotic fractures in 2010. Moreover, the burden is expected to increase in the future with demographic changes and increasing life expectancy. Recent advances in the management of osteoporosis include novel treatments, better fracture-risk assessment notably via fracture risk algorithms, and improved adherence to medication. Economic evaluation can inform decision makers in health care on the cost-effectiveness of the various interventions. Cost-effectiveness analyses suggest that the recent advances in the prevention and treatment of osteoporosis may constitute an efficient basis for the allocation of scarce health-care resources. In summary, health technology assessment is increasingly used in the field of osteoporosis and could be very useful to help decision makers efficiently allocate health-care resources. [less ▲]

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See detailErratum to: Vitamin D Status and Bone Mineral Density Changes During Alendronate Treatment in Postmenopausal Osteoporosis.
Roux, Christian; Binkley, Neil; Boonen, Steven et al

in Calcified tissue international (2013)

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See detailTools in the assessment of sarcopenia.
Cooper, C.; Fielding, R.; Visser, M. et al

in Calcified Tissue International (2013), 93(3), 201-10

This review provides a framework for the development of an operational definition of sarcopenia and of the potential end points that might be adopted in clinical trials among older adults. While the ... [more ▼]

This review provides a framework for the development of an operational definition of sarcopenia and of the potential end points that might be adopted in clinical trials among older adults. While the clinical relevance of sarcopenia is widely recognized, there is currently no universally accepted definition of the disorder. The development of interventions to alter the natural history of sarcopenia also requires consensus on the most appropriate end points for determining outcomes of clinical importance which might be utilized in intervention studies. We review current approaches to the definition of sarcopenia and the methods used for the assessment of various aspects of physical function in older people. The potential end points of muscle mass, muscle strength, muscle power, and muscle fatigue, as well as the relationships between them, are explored with reference to the availability and practicality of the available methods for measuring these end points in clinical trials. Based on current evidence, none of the four potential outcomes in question is sufficiently comprehensive to recommend as a uniform single outcome in randomized clinical trials. We propose that sarcopenia may be optimally defined (for the purposes of clinical trial inclusion criteria as well as epidemiological studies) using a combination of measures of muscle mass and physical performance. The choice of outcome measures for clinical trials in sarcopenia is more difficult; co-primary outcomes, tailored to the specific intervention in question, may be the best way forward in this difficult but clinically important area. [less ▲]

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See detailChanges in Structure and Symptoms in Knee Osteoarthritis and Prediction of Future Knee Replacement Over 8 Years.
Bruyère, Olivier ULg; Cooper, Cyrus; Pavelka, Karel et al

in Calcified Tissue International (2013), 93

The objective of this study was to assess the association between changes in joint space width (JSW, i.e., structure) or Western Ontario and McMaster Universities (WOMAC) score (i.e., symptoms) over 3 ... [more ▼]

The objective of this study was to assess the association between changes in joint space width (JSW, i.e., structure) or Western Ontario and McMaster Universities (WOMAC) score (i.e., symptoms) over 3 years in patients with knee osteoarthritis and the occurrence of knee replacement over 8 years. We followed 133 subjects with primary knee osteoarthritis prospectively for a mean of 8 years. JSW (standard radiography) and symptoms (total WOMAC score) were assessed every year for 3 years. The rate of knee replacement was recorded for the following 5 years. Logistic regressions were performed according to the intention-to-treat principle. After 8 years' follow-up, ten patients (7.5 %) had undergone a knee replacement. The changes in JSW or WOMAC score over 3 years were significantly associated with the occurrence of knee replacement during the following 5 years (p = 0.02 and p = 0.03, respectively). Each 0.1-mm narrowing of JSW over 3 years was associated with a 14 % (95 % CI 3-25 %) increased risk for knee replacement. For every 10 % increase in WOMAC score, the risk for joint replacement was increased by 16 % (95 % CI 1-33 %). When JSW and WOMAC score were included in the same statistical model, they were still significantly associated with risk for knee replacement (p = 0.02 and p = 0.03, respectively), but JSW change was the only variable that remained significant after adjusting for all potential confounders. Our results suggest that changes in symptoms and, more particularly, in structure over 3 years in patients with osteoarthritis reflect a clinically relevant progression of the disease. [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 detailRelationships Between Changes in Bone Mineral Density or Bone Turnover Markers and Vertebral Fracture Incidence in Patients Treated with Bazedoxifene
Bruyère, Olivier ULg; Detilleux, Johann ULg; Chines, Arkadi et al

in Calcified Tissue International (2012), 91(4), 244-9

We analyzed the relationships between bone mineral density (BMD) or bone turnover marker (BTM) changes and vertebral fracture incidence in women treated with bazedoxifene using a post hoc analysis from a ... [more ▼]

We analyzed the relationships between bone mineral density (BMD) or bone turnover marker (BTM) changes and vertebral fracture incidence in women treated with bazedoxifene using a post hoc analysis from a 3-year randomized, placebo-controlled study evaluating the effect of bazedoxifene (20 or 40 mg) on fracture risk reduction. BMD was assessed at baseline and every 6 months for 3 years. Osteocalcin and C-telopeptide of type I collagen were assessed at baseline and at 3, 12, and 36 months. Vertebral fractures were assessed with a semiquantitative visual assessment. Data were available for 5,244 women, of whom 3,476 were treated with bazedoxifene. Using a logistic regression analysis and the classical Li approach, the proportion of fracture incidence explained by BMD change after 3 years of bazedoxifene treatment was 29 % for the total hip and 44 % for the femoral neck. The proportion of treatment explained by lumbar BMD change could not be quantified accurately because of the significant interaction between treatment and change in BMD. With the same model, the 12-month BTM changes explained up to 29 % of the fracture risk reduction observed with the two forms of bazedoxifene. In women treated with bazedoxifene, changes in femoral neck BMD, hip BMD, or BTMs explained a moderate proportion of the fracture risk reduction observed during the 3 years of follow-up. However, BMD or BTM changes cannot be recommended for individual monitoring of women treated with bazedoxifene. [less ▲]

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See detailManagement of glucocorticoid-induced osteoporosis
Rizzoli, R.; Adachi, J. D.; Cooper, C. et al

in Calcified Tissue International (2012), 91(4), 225-243

This review summarizes the available evidence-based data that form the basis for therapeutic intervention and covers the current status of glucocorticoid-induced osteoporosis (GIOP) management, regulatory ... [more ▼]

This review summarizes the available evidence-based data that form the basis for therapeutic intervention and covers the current status of glucocorticoid-induced osteoporosis (GIOP) management, regulatory requirements, and risk-assessment options. Glucocorticoids are known to cause bone loss and fractures, yet many patients receiving or initiating glucocorticoid therapy are not appropriately evaluated and treated. An European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis workshop was convened to discuss GIOP management and to provide a report by a panel of experts. An expert panel reviewed the available studies that discussed approved therapeutic agents, focusing on randomized and controlled clinical trials reporting on bone mineral density and/or fracture risk of at least 48 weeks' duration. There is no evidence that GIOP and postmenopausal osteoporosis respond differently to treatments. The FRAX algorithm can be adjusted according to glucocorticoid dose. Available antiosteoporotic therapies such as bisphosphonates and teriparatide are efficacious in GIOP management. Several other agents approved for the treatment of postmenopausal osteoporosis may become available for GIOP. It is advised to stop antiosteoporotic treatment after glucocorticoid cessation, unless the patient remains at increased risk of fracture. Calcium and vitamin D supplementation as an osteoporosis-prevention measure is less effective than specific antiosteoporotic treatment. Fracture end-point studies and additional studies investigating specific subpopulations (pediatric, premenopausal, or elderly patients) would strengthen the evidence base and facilitate the development of intervention thresholds and treatment guidelines. © Springer Science+Business Media, LLC 2012. [less ▲]

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See detailRandomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency.
Ralston, Stuart H; Binkley, Neil; Boonen, Steven et al

in Calcified Tissue International (2011), 88(6), 485-94

Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D(3) 5,600 IU in a single tablet (ALN/D5600, n = 257 ... [more ▼]

Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D(3) 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score </=2.5 or </=1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70% of cases this was combined with vitamin D supplements. However, only 24% took >/=800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6% in the ALN/D5600 group compared with 31.0% in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57% vs. -46%, P < 0.001) and bone-specific alkaline phosphatase (-47% vs. -40%, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9% vs. 3.9%, P = 0.047) and the total hip (2.2% vs. 1.4%, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3% vs. 36.9%, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. [less ▲]

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See detailAdverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis.
Rizzoli, Rene; Reginster, Jean-Yves ULg; Boonen, Steven et al

in Calcified Tissue International (2011), 89(2), 91-104

The pharmacological management of disease should involve consideration of the balance between the beneficial effects of treatment on outcome and the probability of adverse effects. The aim of this review ... [more ▼]

The pharmacological management of disease should involve consideration of the balance between the beneficial effects of treatment on outcome and the probability of adverse effects. The aim of this review is to explore the risk of adverse drug reactions and drug-drug interactions with treatments for postmenopausal osteoporosis. We reviewed evidence for adverse reactions from regulatory documents, randomized controlled trials, pharmacovigilance surveys, and case series. Bisphosphonates are associated with gastrointestinal effects, musculoskeletal pain, and acute-phase reactions, as well as, very rarely, atrial fibrillation, atypical fracture, delayed fracture healing, osteonecrosis of the jaw, hypersensitivity reactions, and renal impairment. Cutaneous effects and osteonecrosis of the jaw are of concern for denosumab (both very rare), though there are no pharmacovigilance data for this agent yet. The selective estrogen receptor modulators are associated with hot flushes, leg cramps, and, very rarely, venous thromboembolism and stroke. Strontium ranelate has been linked to hypersensitivity reactions and venous thromboembolism (both very rare) and teriparatide with headache, nausea, dizziness, and limb pain. The solidity of the evidence base depends on the frequency of the reaction, and causality is not always easy to establish for the very rare adverse reactions. Drug-drug interactions are rare. Osteoporosis treatments are generally safe and well tolerated, though they are associated with a few very rare serious adverse reactions. While these are a cause for concern, the risk should be weighed against the benefits of treatment itself, i.e., the prevention of osteoporotic fracture. [less ▲]

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See detailAldosterone and parathyroid hormone: a complex and clinically relevant relationship
Pilz, Stefan; Tomaschitz, Andreas; März, Winfried et al

in Calcified Tissue International (2010), 87(4), 373-4

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See detailPotential Clinical and Economic Impact of Nonadherence with Osteoporosis Medications.
Hiligsmann, Mickaël ULg; Rabenda, Véronique ULg; Gathon, Henry-Jean ULg et al

in Calcified Tissue International (2010), 86

This study aims to estimate the potential clinical and economic implications of therapeutic adherence to bisphosphonate therapy. A validated Markov microsimulation model was used to estimate the impact of ... [more ▼]

This study aims to estimate the potential clinical and economic implications of therapeutic adherence to bisphosphonate therapy. A validated Markov microsimulation model was used to estimate the impact of varying adherence to bisphosphonate therapy on outcomes (the number of fractures and the quality-adjusted life-years [QALYs]), health-care costs, and the cost-effectiveness of therapy compared with no treatment. Adherence was divided into persistence and compliance, and multiple scenarios were considered for both concepts. Analyses were performed for women aged 65 years with a bone mineral density T-score of -2.5. Health outcomes and the cost-effectiveness of therapy improved significantly with increasing compliance and/or persistence. In the case of real-world persistence and with a medical possession ratio (MPR; i.e., the number of doses taken divided by the number of doses prescribed) of 100%, the QALY gain and the number of fractures prevented represented only 48 and 42% of the values estimated assuming full persistence, respectively. These proportions fell to 27 and 23% with an MPR value of 80%. The costs per QALY gained, for branded bisphosphonates (and generic alendronate), were estimated at <euro>19,069 (<euro>4,871), <euro>32,278 (<euro>11,985), and <euro>64,052 (<euro>30,181) for MPR values of 100, 80, and 60%, respectively, assuming real-world persistence. These values were <euro>16,997 (<euro>2,215), <euro>24,401 (<euro>6,179), and <euro>51,750 (<euro>20,569), respectively, assuming full persistence. In conclusion, poor compliance and failure to persist with osteoporosis medications results not only in deteriorating health outcomes, but also in a decreased cost-effectiveness of drug therapy. Adherence therefore remains an important challenge for health-care professionals treating osteoporosis. [less ▲]

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See detailUtility values associated with osteoporotic fracture: a systematic review of the literature.
Hiligsmann, Mickaël ULg; Ethgen, Olivier ULg; Richy, Florent et al

in Calcified Tissue International (2008), 82(4), 288-92

We reviewed studies that have estimated the impact of osteoporotic fracture on quality-adjusted life years (QALY) and to determine reference values for countries that would like to carry out cost-utility ... [more ▼]

We reviewed studies that have estimated the impact of osteoporotic fracture on quality-adjusted life years (QALY) and to determine reference values for countries that would like to carry out cost-utility analyses but that do not have their own values. The computerized medical literature databases Medline and EMBASE were searched from January 1990 to December 2006. The search was carried out in two steps. The first step was to identify studies that related to quality of life in osteoporosis. As part of the second step, only the studies that translated quality of life into a utility value (one single value for health status ranging 0-1) and calculated a utility loss over a period of at least 1 year were selected. From the 152 studies identified in the first analysis, only 16 were retained after the second step. Ten studies investigated utility values for hip fractures, 11 for vertebral fractures, five for distal forearm fractures, and four for other osteoporotic fractures and fracture interactions. Utility values differed substantially between studies, partly due to the valuation technique used, the severity of fractures, and the sample size. This review suggests that there is no meaningful average value across different studies, different samples, different countries, or different instruments. Although we tried to determine the best available values, these values do not preclude the need for country-specific studies. Finally, we also make recommendations regarding the design and methodology for such studies. [less ▲]

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See detailStrontium ranelate decreases vertebral fracture risk whatever the level of pretreatment bone turnover markers
COLLETTE, Julien ULg; Reginster, Jean-Yves ULg; Bruyère, Olivier ULg et al

in Calcified Tissue International (2007, May), 80(Suppl.1), 29-30

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See detailStrontium ranelate demonstrates vertebral and non-vertebral antifracture efficacy including hip fractures over 5 years in postmenopausal osteoporotic women
Reginster, Jean-Yves ULg; Brixen, Kim; Cormier, C. et al

in Calcified Tissue International (2007, May), 80(Suppl.1), 47

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See detailThe MOBILE study long-term extension: progressive improvements in efficacy with oral ibandronate (1500mg) when administered monthly
Reginster, Jean-Yves ULg; Cooper, C.; Sedarati, F. et al

in Calcified Tissue International (2007, May), 80(Suppl.1), 144

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