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See detailAdverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis.
Rizzoli, Rene; Reginster, Jean-Yves ULiege; 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 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 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 ULiege; Rabenda, Véronique ULiege; Gathon, Henry-Jean ULiege 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 ULiege; Ethgen, Olivier ULiege; 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 detailThe MOBILE study long-term extension: progressive improvements in efficacy with oral ibandronate (1500mg) when administered monthly
Reginster, Jean-Yves ULiege; Cooper, C.; Sedarati, F. et al

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

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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 ULiege; Brixen, Kim; Cormier, C. et al

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

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

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

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See detailReduction in bone turnover results in a transient highly uniform mineralization state
Ruffoni, Davide ULiege; Fratzl, P.; Roschger, P. et al

in CALCIFIED TISSUE INTERNATIONAL (2007), 80(1), 146-146

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See detailAddressing the musculoskeletal components of fracture risk with calcium and vitamin D: A review of the evidence
Boonen, S.; Bischoff-Ferrari, H. A.; Cooper, C. et al

in Calcified Tissue International (2006), 78(5), 257-270

Osteoporotic fractures are an extremely common and serious health problem in the elderly. This article presents the rationale for calcium and vitamin D supplementation in the prevention and treatment of ... [more ▼]

Osteoporotic fractures are an extremely common and serious health problem in the elderly. This article presents the rationale for calcium and vitamin D supplementation in the prevention and treatment of osteoporotic fractures and reviews the literature evidence on the efficacy of this strategy. Two musculoskeletal risk factors are implicated in osteoporotic fractures in the elderly: the loss of bone mass due to secondary hyperparathyroidism and the increased propensity to falls. Calcium and vitamin D reverse secondary hyperparathyroidism with resultant beneficial effects on bone mineral density (BMD). Additionally, calcium and vitamin D supplementation significantly improves body sway and lower extremity strength, reducing the risk of falls. The effects of combined calcium and vitamin D on parathyroid function and BMD provide a strong rationale for the use of this therapy in the prevention and treatment of osteoporosis and osteoporotic fractures. There is general agreement that, in patients with documented osteoporosis, calcium and vitamin D supplementation should be an integral component of the management strategy, along with antiresorptive or anabolic treatment. Frail elderly individuals constitute another major target population for calcium and vitamin D because evidence from randomized studies in institutionalized elderly subjects demonstrates that these supplements reduce osteoporotic fracture risk, particularly in the presence of dietary deficiencies. However, the results of trials in community-dwelling subjects have been equivocal. Within the primary-care setting, further research is required to establish appropriate target subgroups for calcium and vitamin D supplementation; overall, the data are consistent with a benefit individuals with insufficient calcium and/or vitamin D, although patients with documented osteoporosis will derive further benefit in terms of fracture prevention from the addition of an antiresorptive agent. [less ▲]

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See detailVitamin D analogs versus native vitamin D in preventing bone loss and osteoporosis-related fractures: A comparative meta-analysis
Richy, F.; Schacht, E.; Bruyère, Olivier ULiege et al

in Calcified Tissue International (2005), 76(3), 176-186

It has been suggested that early postmenopausal women and patients treated with steroids should receive preventive therapy (calcium, vitamin D, vitamin D analogs, estrogens, or bisphosphonates) to ... [more ▼]

It has been suggested that early postmenopausal women and patients treated with steroids should receive preventive therapy (calcium, vitamin D, vitamin D analogs, estrogens, or bisphosphonates) to preserve their bone mineral density (BMD) and to avoid fragility fractures. We designed the present study to compare the effects of native vitamin D to its hydroxylated analogs alfacalcidol 1-alpha(OH)D and calcitriol 1,25(OH)(2)D. All randomized, controlled, double-blinded trials comparing oral native vitamin D and its analogs, alfacalcidol or calcitriol, to placebo or head-to-head trials in primary or corticosteroids-induced osteoporosis were included in the meta-analysis. Sources included the Cochrane Controlled Trials Register, EMBASE, MEDLINE, and a hand search of abstracts and references lists. The study period January 1985 to January 2003. Data were abstracted by two investigators, and methodological quality was assessed in a similar manner. Heterogeneity was extensively investigated. Results were expressed as effect-size (ES) for bone loss and as rate difference (RD) for fracture while allocated to active treatment or control. Publication bias was investigated. Fourteen studies of native vitamin D, nine of alfacalcidol, and ten of calcitriol fit the inclusion criteria. The two vitamin D analogs appeared to exert a higher preventive effect on bone loss and fracture rates in patients not exposed to glucocorticoids. With respect to BMD, vitamin D analogs versus placebo studies had an ES of 0.36 (P < 0.0001), whereas native vitamin D versus placebo had an ES of 0.17 (P = 0.0005), the interclass difference being highly significant (ANOVA-1, P < 0.05). When restricted to the lumbar spine, this intertreatment difference remained significant: ES = 0.43 (P = 0.0002) for vitamin D analogs and ES = 0.21 (P = 0.001) for native vitamin D (analysis of variance [ANOVA-1], P = 0.047). There were no significant differences regarding their efficacies on other measurement sites (ANOVA-1, P = 0.36). When comparing the adjusted global relative risks for fracture when allocated to vitamin D analogs or native vitamin D, alfacalcidol and calcitriol provided a more marked preventive efficacy against fractures: RD = 10% (95% Confidence interval [CI-2] to 17) compared to RD = 2% (95% CI, 1 to 2), respectively. The analysis of the spinal and nonspinal showed that fracture rates differed between the two classes, thereby confirming the benefits of vitamin D analogs, with significant 13.4% (95% CI 7.7 to 19.8) and. 6% (95% CI 1 to 12) lower fracture rates for vitamin D analogs, respectively. In patients receiving corticosteroid therapy, both treatments provided similar global ESs for BMD: ES = 0.38 for vitamin D analogs and ES = 0.41 for native vitamin D (ANOVA-1, P = 0.88). When restriced to spinal BMD, D analogs provided significant effects, whereas native vitamin D did not: ES = 0.43 (P < 0.0001) and ES = 0.33 (P = 0.21), respectively. The intertreatment difference was nonsignificant (ANOVA-1, P = 0.52). Neither D analogs for native vitamin D significantly prevented fractures in this subcategory of patients: RD = 2.6 (95%CI, -9.5 to 4.3) and RD = 6.4 (95%CI, -2.3 to 10), respectively. In head-to-head studies comparing D analogs and native vitamin D in patients receiving corticosteroids, significant effects favoring D analogs were found for femoral neck BMD: ES = 0.31 at P = 0.02 and spinal fractures: RD = 15% (95%CI, 6.5 to 25). Publication bias was not significant. Our analysis demonstrates a superiority of the D analogs atfacalcidol and calcitriol in preventing bone loss and spinal fractures in primary osteoporosis, including postmenopausal women. In corticosteroid-induced osteoporosis, the efficacy of D analogs differed depending on the comparative approach: indirect comparisons led to nonsignificant differences, whereas direct comparison did provide significant differences. In this setting, D analogs seem to prevent spinal fractures to a greater extent than do native vitamin D, but this assumption should be confirmed on a comprehensive basis in multiarm studies including an inactive comparator. [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-monthly oral ibandronate a new bisphosphonate dosing concept
Reginster, Jean-Yves ULiege; Miller, P.; Delmas, P. et al

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

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See detailStrontium ranelate reduces the risk of vertebral fractures in postmenopausal women with osteopenia
Sawicki, A.; Reginster, Jean-Yves ULiege; Roux, C. et al

in Calcified Tissue International (2004), 74(S1), 84

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See detailPatients at high risk of hip fracture benefit from treatment with strontium ranelate
Rizzoli, R.; Reginster, Jean-Yves ULiege; Diaz-Curiel, M. et al

in Calcified Tissue International (2004), 74(S1), 83-84

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See detailStrontium ranelate reduces the risk of vertebral fractures in osteoporotic postmenopausal women without prevalent vertebral fracture
Reginster, Jean-Yves ULiege; Rizzoli, R.; Balogh, A. et al

in Calcified Tissue International (2004), 74(S1), 83

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See detailDetection of bone sialoprotein in human (pre)neoplastic lesions of the uterine cervix
Detry, Cédric ULiege; Waltregny, David ULiege; Quatresooz, Pascale ULiege et al

in Calcified Tissue International (2003), 73(1), 9-14

Bone sialoprotein (BSP) is a secreted glycoprotein primarily found in the mineral compartment of developing bones. BSP is detected in a variety of human cancers, particularly those that metastasize to the ... [more ▼]

Bone sialoprotein (BSP) is a secreted glycoprotein primarily found in the mineral compartment of developing bones. BSP is detected in a variety of human cancers, particularly those that metastasize to the skeleton. High expression of BSP in breast and prostate primary carcinomas is associated with progression and bone metastases development. Since squamous cell carcinoma (SCCs) of the uterine cervix also frequently metastasizes to bone, we investigated whether BSP is expressed in human cervical cancer. We examined BSP expression in cervical tissue samples from 47 patients, including 19 normal tissues, 20 squamous intraepithelial lesions (SILs) (9 low and 11 high grade) and 8 invasive SCCs. BSP protein expression was evaluated by the immunophosphatase technique using a BSP polyclonal antibody in paraffin-embedded cervical biopsies. The abundance of BSP protein was significantly higher in invasive SCCs and high grade SILs than in normal cervix tissue samples and low grade SILs, which showed no or a low level of anti-BSP immunoreactivity. In situ hybridization experiments performed on representative cervix invasive SCCs frozen sections revealed that BSP transcripts were detectable in these lesions. Our study demonstrates that BSP expression is a common feature in high grade SILs and invasive SCCs of the uterine cervix. The prognostic value of BSP detection in these lesions and the potential role of BSP as an angiogenic factor in this type of cancer are currently under investigation. [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 Calcified Tissue International (2003), 72

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See detailInfluence of daily regimen calcium and vitamin D supplementation on parathyroid hormone secretion
Reginster, Jean-Yves ULiege; Zegels, Brigitte ULiege; Lejeune, Emmanuelle ULiege et al

in Calcified Tissue International (2002), 70(2), 78-82

Calcium and vitamin D supplementation has been shown to reduce secondary hyperparathyroidism and play a role in the management of senile osteoporosis. In order to define the optimal regimen of calcium and ... [more ▼]

Calcium and vitamin D supplementation has been shown to reduce secondary hyperparathyroidism and play a role in the management of senile osteoporosis. In order to define the optimal regimen of calcium and vitamin D supplementation to produce the maximal inhibition of parathyroid hormone secretion, we have compared the administration of a similar amount of Ca and vitamin D, either as a single morning dose or split in two doses, taken 6 hours apart. Twelve healthy volunteers were assigned to three investigational procedures, at weekly intervals. After a blank control procedure, when they were not exposed to any drug intake, they received two calcium-vitamin D supplement regimens including either two doses of Orocal D3 (500 mg Ca and 400 IU vitamin D) 6 hours apart or one water-soluble effervescent powder pack of Cacit D3 in a single morning dose (1000 mg Ca and 880 IU vitamin D). During the three procedures (control and the two calcium-vitamin D supplementations), venous blood was drawn every 60 minutes for up to 9 hours, for serum Ca and serum PTH measurements. The order of administration of the two Ca and vitamin D supplementation sequences was allocated by randomization. No significant changes in serum Ca were observed during the study. During the 6 hours following Ca and vitamin D supplementation, a statistically significant decrease in serum PTH was observed with both regimens, compared with baseline and with the control procedure. Over this period of time, no differences were observed between the two treatment regimens. However, between the sixth and the ninth hour, serum PTH levels were still significantly decreased compared with baseline with split dose Orocal D3 administration, while they returned to baseline value with the Cacit D3 preparation. During this period, the percentage decrease in serum PTH compared with baseline was significantly more pronounced with Orocal D3 than with Cacit D3 (P = 0.0021). We therefore conclude that the administration of two doses of 500 mg of calcium and 400 IU of vitamin D3 6 hours apart provides a more prolonged decrease in serum PTH levels than the administration of the same total amount of Ca and vitamin D as a single morning dose in young healthy volunteers. This might have implications in terms of protection of the skeleton against secondary hyperparathyroidism and increased bone resorption and turnover in elderly subjects. [less ▲]

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