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See detailDenosumab treatment of postmenopausal women with osteoporosis for 6 years : results from the first 3 years of the freedom extension
Papapoulos, S; Brown, JP; Chapurlat, R et al

in Osteoporosis International (2012, March), 23(S2), 76

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See detailFive years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension.
Papapoulos, S.; Chapurlat, R.; Libanati, C. et al

in Journal of Bone and Mineral Research (2012), 27(3), 694-701

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to ... [more ▼]

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to enter an extension to continue the evaluation of denosumab efficacy and safety for up to 10 years. For the extension results presented here, women from the FREEDOM denosumab group had 2 more years of denosumab treatment (long-term group) and those from the FREEDOM placebo group had 2 years of denosumab exposure (cross-over group). We report results for bone turnover markers (BTMs), bone mineral density (BMD), fractures rates, and safety. A total of 4550 women enrolled in the extension (2343 long-term; 2207 cross-over). Reductions in BTMs were maintained (long-term group) or occurred rapidly (cross-over group) following denosumab administration. In the long-term group, lumbar spine and total hip BMD increased further, resulting in 5-year gains of 13.7% and 7.0%, respectively. In the cross-over group, BMD increased at the lumbar spine (7.7%) and total hip (4.0%) during the 2-year denosumab treatment. Yearly fracture incidences for both groups were below rates observed in the FREEDOM placebo group and below rates projected for a "virtual untreated twin" cohort. Adverse events did not increase with long-term denosumab administration. Two adverse events in the cross-over group were adjudicated as consistent with osteonecrosis of the jaw (ONJ). Five-year denosumab treatment of women with postmenopausal osteoporosis maintained BTM reduction and increased BMD, and was associated with low fracture rates and a favorable risk/benefit profile. (c) 2011 American Society for Bone and Mineral Research. [less ▲]

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See detailTreatment of postmenopausal women with osteoporosis for six years with denosumab : three-year results from the freedom extension
Chapurlat, R; Papapoulos, S; Brown, JP et al

in Annals of the Rheumatic Diseases (2012), 71(3), 588

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See detailFive-year Denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the freedom trial extension
Papapoulos, S.; Man, Z.; Mellstrom, D. et al

in Osteoporosis International (2011, March), 22(Suppl.1), 107-108

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See detailDenosumab therapy in postmenopausal women with osteoporosis : results from the first two years of the freedom trial extension
Bone, H. G.; Chapurlat, R.; Brandi, M. L. et al

in Endocrine Reviews (2011), 32

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See detailSafety observations from denosumab long-term extension and cross-over studies in postmenopausal women with osteoporosis
Bone, H. G.; Chapurlat, R.; Libanati, C. et al

in Journal of Bone and Mineral Research (2011), 26(S1), 22-23

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See detailTraitement durant cinq ans par denosumab (DMAb) chez des femmes ménopausées ostéoporotiques : résultats d'efficacité des deux premières années de l'extension de l'essai FREEDOM
Chapurlat, R.; Roux, C.; Papapoulos, S. et al

in Revue du Rhumatisme (2011), 78(S5), 214

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See detailTreatment of postmenopausal women with osteoporosis for 5 years with denosumab : two-year results from the FREEDOM trial extension
Chapurlat, R.; Bone, H. G.; Brandi M L et al

in Annals of the Rheumatic Diseases (2011), 70(S3), 166-167

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See detailExtended safety observations from denosumab administration in postmenopausal women from FREEDOM and FREEDOM extension trials
Brown, J. P.; Bone, H. G.; Chapurlat, R. et al

in Arthritis and Rheumatism (2011), 63(S10), 431-432

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See detailLong-term denosuamab treatment in postmenopausal women with osteoporosis : results from the first two years of the FREEDOM trial extension
Bone, H.; Chapurlat, R.; Brandi, M. et al

in Osteoporosis International (2011), 22(S4), 527-528

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See detailEffect of raloxifene combined with monofluorophosphate as compared with monofluorophosphate alone in postmenopausal women with low bone mass: a randomized, controlled trial
Reginster, Jean-Yves ULg; Felsenberg, D.; Pavo, I. et al

in Osteoporosis International (2003), 14(9), 741-749

Raloxifene effectively reduces the incidence of vertebral fractures in patients with postmenopausal osteoporosis. Recent data suggest that low-dose monofluorophosphate (MFP) plus calcium reduces the ... [more ▼]

Raloxifene effectively reduces the incidence of vertebral fractures in patients with postmenopausal osteoporosis. Recent data suggest that low-dose monofluorophosphate (MFP) plus calcium reduces the vertebral fracture rate in postmenopausal women with moderate osteoporosis. The objective of this study was to evaluate the combination of raloxifene and MFP in the treatment of postmenopausal women with osteopenia, osteoporosis and severe osteoporosis. A total of 596 postmenopausal women with osteopenia, osteoporosis and severe osteoporosis (mean femoral neck T-score of -2.87 SD) were randomized to treatment with 60 mg/day raloxifene HCl and 20 mg/day fluoride ions (as MFP) or 20 mg/day fluoride and placebo for 18 months. All patients received calcium (1000 mg/day) and vitamin D (500 IU/day) supplements. Changes in bone mineral density (BMD), as primary endpoint, and the rate of osteoporotic fractures and biochemical markers, as secondary endpoints, were assessed. As compared with MFP, raloxifene plus MFP was associated with significantly greater mean increases in the BMD of the femoral neck (1.37% versus 0.33%; P=0.004), total hip (0.89% versus -0.42%; P<0.001) and lumbar spine (8.80% versus 5.47% P<0.001). In the raloxifene plus MFP group, 16 patients sustained 17 osteoporotic fractures, as compared with 22 patients sustaining 34 incident osteoporotic fractures in the MFP group (P=0.313). One patient in the raloxifene plus MFP group sustained multiple osteoporotic fractures, as compared with eight patients in the MFP group (P=0.020). MFP alone significantly increased the serum bone alkaline phosphatase (bone ALP) and the urinary C-terminal crosslinking telopeptide of type I collagene (U-CTX). The addition of raloxifene in the combination arm blunted the rise in bone ALP, which remained nevertheless significant, and abolished the increase in U-CTX. The combination of raloxifene with MFP was generally well tolerated. This study demonstrates that, in postmenopausal women with osteopenia, osteoporosis and severe osteoporosis, the combination therapy of raloxifene plus MFP favorably influences the BMD and the bone formation and resorption balance, and may reduce the risk of multiple osteoporotic fractures compared to MFP alone. [less ▲]

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See detailReduction in vertebral fracture rates by a combination of monofluorophosphate and raloxifene in postmenopausal osteoporosis
Durez, P.; Felsenberg, D.; Stepan, J. et al

in Annals of the Rheumatic Diseases (2002, June), 61(Suppl.1),

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See detailThe effect on bone turnover of monofluorophosphate (MFP) combined with raloxifene (RLX) as compared to MFP alone in postmenopausal women with low bone mass
Stepan, J.; Payer, J.; Resch, H. et al

in Osteoporosis International (2002), 13(S1), 54

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