Strontium Ranelate Demonstrates Vertebral and Non-Vertebral Anti Fracture Efficacy Including Hip Fractures Over 5 Years in Post Menopausal Osteoporotic Women

Reginster, Jacques; Brixen, Kim; Cormier, Catherine; Cannata, J. B.

doi:10.14341/osteo2007226-

Cited by 9 publications

(16 citation statements)

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“…However, in a subgroup of high risk patients aged 74 y and over and with an NHANES III femoral neck T-score <−2.4 there was a 36% reduction in hip fracture risk (incidence 4.3% vs 6.4%; RR=0.64; 95% CI: 0.412–0.997; p=0.046; NNT=48) (Figure 3). The 5-year results of the TROPOS study show continuing long-term efficacy with a 15% reduction in non-vertebral fractures (RR = 0.85; 95% CI: 0.73–0.99; p=0.03) (Reginster et al 2006) (Figure 3). …”

Section: Non-vertebral Fracture Prevention By Strontium Ranelatementioning

confidence: 98%

“…The pooled 3-year data from the SOTI and TROPOS studies gave a total population of 5082 women for the evaluation of vertebral fracture risk and showed an overall reduction in fracture risk of 40% over three years (RR=0.60; 95% CI: 0.53–0.69; p<0.001) (Roux et al 2006). The recently presented 5-year TROPOS data show a 24% reduction in vertebral fracture risk (RR=0.76; 95% CI: 0.65–0.87; p<0.001) (Reginster et al 2006). Although both the SOTI and TROPOS data show a slight decline in antifracture efficacy the longer treatment is given (Figure 2), such a trend is expected since with the Kaplan-Meier analysis patients are censored after their first fracture and with time the remaining subjects in the treated and placebo groups become less well matched.…”

Section: Vertebral Fracture Prevention By Strontium Ranelatementioning

confidence: 99%

“…Over this period the number of patients treated to prevent one vertebral fracture (NNT) was 9. The four-year SOTI study fracture data were recently published in a conference abstract (Reginster et al 2006) and show a 33% reduction in the risk of a new vertebral fracture in the strontium ranelate group compared with placebo (RR=0.67; 95% CI: 0.55–0.81; p<0.001). The 1 y, 3 y, and 4 y data are summarized in Figure 2.…”

Section: Vertebral Fracture Prevention By Strontium Ranelatementioning

confidence: 99%

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Strontium ranelate: a novel treatment for postmenopausal osteoporosis: a review of safety and efficacy

Blake¹,

Fogelman²

2006

Clinical Interventions in Aging

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Strontium ranelate is a new orally administered agent for the treatment of women with postmenopausal osteoporosis that reduces the risk of vertebral and hip fractures. Evidence for the safety and efficacy of strontium ranelate comes from two large multinational trials, the SOTI (Spinal Osteoporosis Therapeutic Intervention) and TROPOS (Treatment Of Postmenopausal Osteoporosis) studies. The SOTI study evaluated vertebral fracture prevention in 1649 postmenopausal women with a mean age of 69 y. The subjects all had at least one previous vertebral fracture and a low spine bone mineral density (BMD) (equivalent to a Hologic spine T-score below −1.9). The strontium ranelate group had a 41% lower risk of a new vertebral fracture than the placebo group over the three-year study period (relative risk [RR]=0.59; 95% confidence interval [CI]: 0.48–0.73; p<0.001). The TROPOS study evaluated non-vertebral fracture prevention in 5091 postmenopausal women with a mean age of 77 y. The subjects were aged 74 y and over (or 70–74 y with one additional risk factor) and a low femoral neck BMD (equivalent to an NHANES III [Third National Health and Nutrition Examination Survey] T-score below −2.2). Over the three-year study period there was a 16% reduction in all non-vertebral fractures (RR=0.84; 95% CI 0.702–0.995; p=0.04) and a 19% reduction at the principal sites for non-vertebral fractures. The TROPOS study was not powered to investigate hip fracture risk. However, in a high risk group of women aged 74 y and over and with an NHANES III femoral neck T-score less than −2.4 there was a 36% reduction in hip fracture risk (RR=0.64; 95% CI: 0.412–0.997; p=0.046). The overall incidence of adverse events did not differ significantly from placebo and were generally mild and transient, the most common being nausea and diarrhea. Strontium ranelate is a useful addition to the range of anti-fracture treatments available for treating postmenopausal women with osteoporosis and is the only treatment proven to be effective at preventing both vertebral and hip fractures in women aged 80 y and over.

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Section: Non-vertebral Fracture Prevention By Strontium Ranelatementioning

confidence: 98%

Section: Vertebral Fracture Prevention By Strontium Ranelatementioning

confidence: 99%

Section: Vertebral Fracture Prevention By Strontium Ranelatementioning

confidence: 99%

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Strontium ranelate: a novel treatment for postmenopausal osteoporosis: a review of safety and efficacy

Blake¹,

Fogelman²

2006

Clinical Interventions in Aging

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“…More robust evidence of long-term efficacy of up to 5 years is available for strontium ranelate, both for vertebral and non-vertebral fractures [41]. Although the mechanisms by which this drug exerts its beneficial skeletal effects are currently unclear, bone turnover appears to be only minimally suppressed.…”

Section: Effects Of Long-term Antiresorptive Agents On Fracture Riskmentioning

confidence: 99%

Over-suppression of bone turnover: Does it exist?

Compston

2007

Curr Osteoporos Rep

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Bone-turnover suppression is central to the therapeutic benefit of many interventions used to prevent osteoporotic fractures. There are theoretical concerns that long-term suppression may have adverse effects on bone strength, although at present no direct evidence exists that this happens. Nevertheless, further research is required to establish the optimal duration of treatment with antiresorptive agents.

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“…This agent decreased the relative risk of hip fracture by 36% in patients aged 74 years or more and with a femoral neck bone mineral density 72.4 standard deviations (using the Third National Health and Nutrition Examination Survey reference range). The efficacy of strontium ranelate was even specifically demonstrated in elderly patients (age 80 years) with a significant reduction in both vertebral (732%) and non-vertebral (731%) risks of fracture over 3 years 22 . An extension of the phase 3 trials up to 5 years has shown a sustained antifracture efficacy, with 724% and 718% reductions in vertebral and non-vertebral fractures, respectively, after 5 years of placebo-controlled study.…”

Section: Agents With New Mechanisms Of Actionmentioning

confidence: 99%

Osteoporosis: non-hormonal treatment

Rizzoli

2007

Climacteric

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Significant progress has been achieved in osteoporosis treatment, in terms of agents with novel mechanisms of action, of new schedules of administration, and of long-term treatment safety demonstration. Alendronate, ibandronate, intranasal calcitonin, parathyroid hormones, raloxifene, risedronate, hormone replacement therapy, strontium ranelate and zoledronate decrease the risk of vertebral fracture. Alendronate, risedronate, strontium ranelate and zoledronate reduce the risk of hip fracture in women with osteoporosis, hormone replacement therapy in postmenopausal women, and calcium and vitamin D in institutionalized patients. In two meta-analyses, the combination of calcium and vitamin D was able to reduce the risk of falling, and hip fracture risk was decreased (>700 IU/day). Two subsequently published large trials were unable to detect any antifracture effect. PTH(1-84) reduces the risk of new vertebral fracture. There is no indication that combining PTH with a bone resorption inhibitor has any additional benefit to either drug alone. Strontium ranelate is a new agent for the treatment of osteoporosis, with antifracture efficacy whatever the severity of osteoporosis. An extension of the phase 3 trials up to 5 years has shown sustained antifracture efficacy. The humanized monoclonal antibody to the receptor activator of nuclear factor-kappaB ligand (RANKL) denosumab causes a rapid, high-magnitude, dose-dependent inhibition of bone resorption. Spine, hip and forearm bone mineral density increased, to an extent slightly higher than with the weekly administration of 70 mg alendronate.

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Strontium Ranelate Demonstrates Vertebral and Non-Vertebral Anti Fracture Efficacy Including Hip Fractures Over 5 Years in Post Menopausal Osteoporotic Women

Cited by 9 publications

References 0 publications

Strontium ranelate: a novel treatment for postmenopausal osteoporosis: a review of safety and efficacy

Strontium ranelate: a novel treatment for postmenopausal osteoporosis: a review of safety and efficacy

Over-suppression of bone turnover: Does it exist?

Osteoporosis: non-hormonal treatment

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