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See detailStrontium Ranelate (Fujisawa/Servier)
Jupsin, Isabelle ULg; Collette, Julien ULg; Henrotin, Yves ULg et al

in Current Opinion in Investigational Drugs (London, England : 2000) (2005), 6(4), 435-44

Strontium ranelate (PROTELOS), a divalent strontium salt, has been developed and launched by Servier for the treatment of osteoporosis. Fujisawa Pharmaceutical is developing the drug in Japan; in November ... [more ▼]

Strontium ranelate (PROTELOS), a divalent strontium salt, has been developed and launched by Servier for the treatment of osteoporosis. Fujisawa Pharmaceutical is developing the drug in Japan; in November 2004, phase II Japanese trials were ongoing. [less ▲]

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See detailStrontium ranelate: A new paradigm in the treatment of osteoporosis
Reginster, Jean-Yves ULg; Deroisy, Rita ULg; Jupsin, Isabelle ULg

in Drugs of Today (2003), 39(2), 89-101

Not one of the currently available medications has, so far, unequivocally demonstrated its ability to fully prevent the occurrence of new vertebral or peripheral osteoporotic fractures once osteoporosis ... [more ▼]

Not one of the currently available medications has, so far, unequivocally demonstrated its ability to fully prevent the occurrence of new vertebral or peripheral osteoporotic fractures once osteoporosis is established. Therefore, several new therapies are currently under development to optimize the risk/benefit ratio of osteoporosis treatment. Strontium ranelate is composed of an organic moiety (ranelic acid) and of two atoms of stable nonradioactive strontium. In vitro, strontium ranelate increases Collagen and noncollagenic proteins synthesis by mature osteoblast enriched cells. The effects of strontium ranelate on bone formation were confirmed as strontium ranelate enhanced pre-osteoblastic cell replication. The stimulation by strontium ranelate of the replication of osteoprogenitor cell and collagen, as well as noncollagenic protein synthesis in osteoblasts, provides substantial evidence to categorize strontium ranelate as a bone-forming agent. In the isolated rat osteoclast assay, a pre-incubation of bone slices with strontium ranelate induced a dose-dependent inhibition of the bone resorbing activity of treated rat osteoclast. Strontium ranelate also dose-dependently inhibited, in a chicken bone marrow culture, the expression of both carbonic anhydrase 11 and the (x-subunit of the vitronectin receptor. These effects showing that strontium ranelate significantly affects bone resorption due to a direct and/or matrix-mediated inhibition of osteoclast activity and also inhibits osteoclasts differentiation, are compatible with the profile of an anti-resorptive drug. In normal rats, administration of strontium ranelate induces an improvement in the mechanical properties of the humerus and/or the lumbar vertebra associated with a commensurate increase in bone dimension, shaft and volume. Strontium ranelate was administered in 160 early postmenopausal women, in a 24-month, double-blind, placebo-controlled, prospective randomized study. Daily oral dose of 125 mg, 500 mg and 1 g of strontium ranelate were compared with a placebo. At the conclusion of the study, the percent variation of lumbar-adjusted bone mineral density from baseline was significantly different in the group receiving 1 g/day of strontium ranelate compared with placebo (+1.41% vs. -0.98%, respectively). Increase in total hip and neck bone mineral density averages, respectively, 3.2% and 2.5%. Strontium ranelate does not induce any significant adverse reaction compared with those observed in women receiving a placebo for the same duration. In a phase 11 study, the effect of strontium ranelate in postmenopausal women with vertebral osteoporotic fractures was assessed during a double-blind, placebo-controlled trial. Doses of 500 mg, 1 g and 2 g daily of strontium ranelate or placebo were given to 353 Caucasian women with prevalent osteoporosis. At the conclusion of this 2-year study, the annual increase in lumbar-adjusted bone mineral density of the group receiving 2 g of strontium ranelate was +2.97%. This result was significantly different compared with placebo. A significant increase in bone alkaline phosphatase and, over a 6-month period, a significant decrease in urinary-pyridium crosslinks (NTX) were evidenced. During the second year of treatment, the dose of 2 g was associated with a 44% reduction in the number of patients experiencing a new vertebral deformity. Bone histomorphometry showed no mineralization defects. The same percentage of withdrawals following an adverse effect was observed for patients receiving placebo and for those receiving 2 g of strontium ranelate. The compound was further investigated in a large phase III program that included two extensive trials for the treatment of severe osteoporosis, one assessing the effects of strontium ranelate on the risk of vertebral fractures (SOTI) and one evaluating its effects on peripheral (nonspinal) fractures (TROPOS). The primary analysis of the SOTI study, evaluating the effect of 2 g of strontium ranelate on vertebral fracture rates, revealed a 41% reduction in the relative risk of experiencing a first new vertebral fracture with strontium ranelate, throughout the 3-year study, compared with placebo. The TROPOS study, showed a significant (p = 0.05) reduction in the relative risk of experiencing a first non-vertebral fracture in the group treated with strontium ranelate throughout the 3-year study compared with placebo in the intention-to-treat population. A 41% reduction in the relative risk of experiencing a hip fracture was demonstrated in the per protocol population. All these results imply that strontium ranelate is a new, effective and safe treatment for vertebral and nonvertebral osteoporosis, with a unique mode of action. (C) 2003 Prous Science. All rights reserved. [less ▲]

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See detailPrevention of early postmenopausal bone loss by strontium ranelate: The randomized, two-year, double-masked, dose-ranging, placebo-controlled PREVOS trial
Reginster, Jean-Yves ULg; Deroisy, Rita ULg; Dougados, M. et al

in Osteoporosis International (2002), 13(12), 925-931

Early postmenopausal women (n = 160) were randomised to receive placebo or strontium ranelate (SR) 125 mg/day, 500 mg/day or 1 g/day for 2 years (40 participants per group). All participants received ... [more ▼]

Early postmenopausal women (n = 160) were randomised to receive placebo or strontium ranelate (SR) 125 mg/day, 500 mg/day or 1 g/day for 2 years (40 participants per group). All participants received calcium 500 mg/day. The primary efficacy parameter was the percent variation in lumbar bone mineral density (BMD), measured using dual-energy X-ray absorptiometry. Secondary efficacy criteria included hip BMD and biochemical markers of bone turnover. At month 24, SR I g/day significantly increased lumbar BMD compared with placebo [mean (SD) +5.53% (5.12); p < 0.001] for measured values and [mean (SD) + 1.41% (5.33%); p < 0.05] for values adjusted for bone strontium content. The annual increase for adjusted values was +0.66% compared with -0.5% with placebo, with an overall beneficial effect after 2 years of about 2.4% with SR I g/day relative to placebo. There were no other significant between-group differences in adjusted lumbar BMD. Femoral neck and total hip BMD were also significantly increased at month 24 with SR I g/day compared with placebo [mean (SD): +2.46% (4.78) and +3.21% (4.68), respectively; both p < 0.001)]. SR 1 g/day significantly increased bone alkaline phosphatase at all time points (p < 0.05) compared with baseline and between-group analysis showed a significant increase, compared with placebo, at month 18 (p = 0.048). No effect on markers of bone resorption was observed. SR was as well tolerated as placebo. The minimum does at which SR is effective in preventing bone loss in early postmenopausal non-osteoporotic women is therefore 1 g/day. [less ▲]

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See detailAdministration of a supplement containing both calcium and vitamin D is more effective than calcium alone to reduce secondary hyperparathyroidism in postmenopausal women with low 25(OH)vitamin D circulating levels
Deroisy, Rita ULg; Collette, Julien ULg; Albert, Adelin ULg et al

in Aging Clinical & Experimental Research (2002), 14(1), 13-17

Background and aims: Supplementation of postmenopausal women with calcium alone or calcium-vitamin D association was suggested to have positive effects on bone turnover and bone density, as well as to ... [more ▼]

Background and aims: Supplementation of postmenopausal women with calcium alone or calcium-vitamin D association was suggested to have positive effects on bone turnover and bone density, as well as to lower fracture incidence. The beneficial effect appears to be mediated by a reduction in parathyroid hormone secretion. Our aim was to compare the respective efficacy of calcium and calcium-vitamin D supplements in reducing serum parathyroid hormone levels in postmenopausal women with prevalent low 25(OH)vitamin D levels. Methods: One hundred consecutive ambulatory postmenopausal women with serum 25(OH)vitamin D levels below 18 ng/mL were included in a randomized, prospective, open label study. For a duration of 90 days, the women were randomly assigned to a daily supplementation of either one tablet of calcium gluconolactate and carbonate (500 mg calcium), or one powder-pack of an association of calcium carbonate (500 mg calcium), citric acid (2.175 gr) and cholecalciferol (200 IU). Changes observed during the 90 days of the study in circulating PTH levels were the primary endpoint, while changes in serum 25(OH)D levels were assessed as secondary endpoint. Results: A significant difference was observed between the calcium-vitamin D (CaD) and the calcium (Ca) only groups for changes occurring during the 90 days of the study in PTH (-14.5 +/- 40% and +2.5 +/- 46%) (p=0.009) and 25(OH)D (+67 +/- 77% and +18 +/- 55%) (p<0.001) circulating levels. PTH changes between baseline and day 90 were significant in the CaD group, but not in the Ca group. The odds ratio for a patient in group Ca to experience an absolute (<12 ng/mL) deficiency in circulating 25(OH)vitamin D levels, compared to a group CaD patient was statistically increased (OR: 3.22, 95% CI: 1.33-7.80). Conclusions: Our results support the recommendation of supplementing postmenopausal women with low circulating levels of 25(OH)vitamin D with a combination of calcium and vitamin D, rather than with calcium alone. [less ▲]

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See detailPrevention of early postmenopausal bone loss by strontium ranelate : a randomised, two-year, double-blind, placebo-controlled trial
Reginster, Jean-Yves ULg; DEROISY, Rita ULg; Tsouderos, Y et al

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

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See detailPrevention of Postmenopausal Bone Loss by Rectal Calcitonin
Reginster, Jean-Yves ULg; Jupsin, Isabelle ULg; Deroisy, Rita ULg et al

in Calcified Tissue International (1995), 56

A group (150) of healthy women, who had been menopausal for less than 5 years and who had never received any form of treatment to prevent bone loss were entered into a randomized, controlled study ... [more ▼]

A group (150) of healthy women, who had been menopausal for less than 5 years and who had never received any form of treatment to prevent bone loss were entered into a randomized, controlled study comprising three arms. They were randomly allocated to the double-blind administration of five suppositories per week containing either 100 IU of salmon calcitonin or a placebo, or to a group receiving a suppository containing 200 IU of salmon calcitonin three times per week. All women received 500 mg/day of calcium supplementation. After 12 months, bone mineral density (BMD) of the spine, measured by dual energy X-ray absorptiometry, decreased significantly (P < 0.01) in the placebo group by 3.1% (SD: 3.6%) but did not change in the two calcitonin groups [+1.3% (3.5%) with 100 IU/day and +2.3% (4.0%) with 200 IU 3/week]. The differences in response between the placebo group and the two calcitonin groups were significant (P < 0.05), but the difference between the two regimens of calcitonin administration was not. No differences appeared among the three groups for the response at the level of the hip. Evolution of biochemical markers reflecting bone turnover did not differ significantly among groups. Nearly 40% of the women withdrew prematurely because of local (rectal or intestinal) intolerance to repetitive suppositories, with a nonsignificantly different frequency in the placebo or calcitonin groups. We conclude that rectal calcitonin might be an interesting preventive approach against trabecular postmenopausal bone loss but that long-term acceptability of suppositories should be evaluated in view of each patient's sensibility or cultural background. [less ▲]

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See detailA Double-Blind, Placebo-Controlled, Dose-Finding Trial of Intermittent Nasal Salmon Calcitonin for Prevention of Postmenopausal Lumbar Spine Bone Loss
Reginster, Jean-Yves ULg; Deroisy, Rita ULg; Lecart, M. P. et al

in American Journal of Medicine (1995), 98(5), 452-8

PURPOSE: Nasal administration of salmon calcitonin (SCT) has been suggested for preventing trabecular bone loss during the first years following the menopause, but no conclusive evidence has appeared ... [more ▼]

PURPOSE: Nasal administration of salmon calcitonin (SCT) has been suggested for preventing trabecular bone loss during the first years following the menopause, but no conclusive evidence has appeared about the minimal effective dose. Since nasal calcitonin is highly expensive, it makes sense to define this dose. PATIENTS AND METHODS: We performed a double-blind, placebo-controlled, randomized, single-center study with a 3-arm parallel-group design. The subjects were 251 healthy women who had experienced natural menopause within the past 6 to 72 months and were not affected by any diseases or treatments that interfere with calcium metabolism. They were randomly allocated in groups of 6 to receive intranasal SCT 50 IU (n = 84), SCT 200 IU (n = 84), or placebo (n = 83). All treatments were given on 5 consecutive days per week. Statistical analysis was based on two populations: intention-to-treat (IT) and valid completers (VC). The main assessments performed were bone mineral density of the lumbar spine (LSBMD) and biochemical parameters reflecting bone turnover (serum alkaline phosphatase, urinary calcium/creatinine, and hydroxyproline/creatinine ratios). RESULTS: Changes over the treatment period were comparable in the IT and VC populations. In the group receiving the placebo, LSBMD decreased from baseline to end point by a mean of 6.28% (95% confidence interval [CI] -7.69 to -4.89) in the IT population and 6.98% (95% CI -8.86 to -5.11) in the VC population (P = 0.0001, end LSBMD versus baseline LSBMD). LSBMD increased slightly with the 50-IU/d dose of SCT, by 0.82% (95% CI -0.26 to 1.89) in the IT population, and 0.51% (95% CI -0.69 to 1.72) in the VC (P = NS, versus baseline). Subjects who received SCT 200 IU/d experienced significant increases of 2.03% (95% CI 0.92 to 3.15) in the IT population and 2.26% (95% CI 1.01 to 3.51) in the VC (both P = 0.001). The difference between the evolution of the combined groups receiving nasal SCT and the group treated with the placebo was highly significant (P = 0.0001). No significant changes were recorded in biochemical parameters reflecting bone turnover. CONCLUSIONS: SCT 50 IU/d administered nasally and intermittently appears to prevent lumbar bone loss in nonobese early postmenopausal women. [less ▲]

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See detailLong-Term Performance in Vitro and in Vivo of Dual-Energy X-Ray Absorptiometry
Reginster, Jean-Yves ULg; Deroisy, Rita ULg; Zegels, Brigitte ULg et al

in Clinical Rheumatology (1995), 14(2), 180-6

Dual-energy X-ray absorptiometry (DXA) is actually considered as one of the most appropriate techniques for measuring bone mineral content (BMC) and bone mineral density (BMD). An anthropomorphic phantom ... [more ▼]

Dual-energy X-ray absorptiometry (DXA) is actually considered as one of the most appropriate techniques for measuring bone mineral content (BMC) and bone mineral density (BMD). An anthropomorphic phantom and a 25-year-old girl were repeatedly measured, 160 times and 50 times respectively, over an 18-month period to investigate performance in vitro and in vivo of a commercial DXA equipment (HOLOGIC QDR 1000). DXA is a highly accurate technique, the BMC and BMD determinations only overestimated the exact value of the phantom by 0.20% and 0.51% respectively. In vivo long-term (18 months) reproducibility of BMD of the spine is characterized by an interassay coefficient of variation (CVt) of 0.8% while, for the different regions of interest of the hip, BMD CVt varies from 1.1% (total zone) to 5.3% (Ward's triangle). In the subject tested, BMD sensitivity for changes of 2.2% at the lumbar spine and 3% at the hip were recorded. [less ▲]

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See detailA 5-Year Controlled Randomized Study of Prevention of Postmenopausal Trabecular Bone Loss with Nasal Salmon Calcitonin and Calcium
Reginster, Jean-Yves ULg; Meurmans, L.; Deroisy, Rita ULg et al

in European Journal of Clinical Investigation (1994), 24(8), 565-9

The aim of this paper was to evaluate the long-term (5 years) efficacy of nasal salmon calcitonin in prevention of trabecular postmenopausal bone loss, which was a follow-up of a previously published ... [more ▼]

The aim of this paper was to evaluate the long-term (5 years) efficacy of nasal salmon calcitonin in prevention of trabecular postmenopausal bone loss, which was a follow-up of a previously published study (3 years); a randomized, controlled group comparison. One hundred healthy postmenopausal women were randomly chosen from those (186) having completed the 3 year protocol. The 100 women were allocated to an additional 2 year period (total of 5 years) of treatment with either 500 mg d-1, 5 days week-1 of calcium or the same amount of calcium plus 50 IU d-1, 5 days per week of nasal salmon calcitonin, 87 (87%) women complied with the protocol throughout. The main outcome measures were the bone mineral density of the lumbar spine (1-BMD) (DPA) and biochemical parameters reflecting bone turnover (serum alkaline phosphatases, urinary calcium/creatinine and hydroxyproline/creatinine ratios). The women receiving calcium alone presented a significant decrease in 1-BMD after 6 months [-1.6 (0.5)%] [mean(SEM)] (P < 0.01) and this decrease remained significant after 36 months [-6.1(0.8)%] (P < 0.01) and until the end of the trial [-6.6(1.0)% at t60] (P < 0.01). In women receiving calcium and calcitonin, 1-BMD significantly increased after 36 months [+2(0.7%] (P < 0.01) and 42 months [+2.5(0.7)%] (P < 0.01 and was unchanged at the other times of investigation [+1.1 (1.1)% at t60] (NS). The evolution of BMD in the two groups was highly significantly different (P < 0.001) since the sixth month of the study and remained so until the end of the study.(ABSTRACT TRUNCATED AT 250 WORDS) [less ▲]

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