Research: Protelos, strontium ranelate.

There have been a number of published studies about Protelos (strontium ranelate) in recent years. Here are some summaries.

  • "Strontium Ranelate as a new therapeutic agent for osteoporosis." by Imanishi Y, Nishizawa Y. Department of Metabolism, Endocrinilogy and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan. Clinical Calcium. 2005 Jan;15(1):25-8.

    ABSTRACT:
    "Strontium ranelate is a new chemical entity, which was recently demonstrated to reduce the fracture risk in osteoporosis patients. This unique compound has both stimulatory effect of osteoblast-mediated bone formation and inhibitory effect of osteoclast-mediated bone resorption, leading to increased bone mass."

    http://www.ncbi.nlm.nih.gov/ - query

When reading these studies remember that strontium ranelate is the scientific term for Protelos. Portelos is the brand name.
  • "Clinical effects of strontium ranelate in women with postmenopausal osteoporosis." by Delmas PD.,INSERM Unit 403, Hopital E. Herriot, 5 place Arsonval, F69437 Lyon Cedex 03, France. delmas@lyon.inserm.frOsteoporos Int. 2005 Jan;16 Suppl 1:S16-9.

    ABSTRACT:"Postmenopausal osteoporosis has long-term physical, psychological, and social consequences with a major impact on patients' daily life. Treatment for such a chronic disease needs to be clinically effective and well tolerated, and should ultimately result in a beneficial effect on quality of life. The antifracture efficacy of strontium ranelate, 2 g/day orally, an agent that appears to have dissociation effects on resorption and formation, has been assessed in two large, randomized, double-blind, placebo-controlled clinical studies: the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial and the TReatment Of Peripheral Osteoporosis Study (TROPOS), including more than 6,700 postmenopausal women. Pending the results of TROPOS, a 3-year analysis of SOTI results shows that strontium ranelate significantly reduces new vertebral and clinical vertebral fracture incidence in postmenopausal osteoporotic women. This significant reduction in the risk of clinical and new vertebral fractures has been demonstrated as early as after 1 year of treatment (RR = 0.48, p = 0.003; and RR = 0.51, p < 0.001, respectively) and is maintained over 3 years (RR = 0.62, p < 0.001; and RR = 0.59, p < 0.001, respectively). This is accompanied by decreased back pain and body height loss in the strontium ranelate group compared with the placebo group.

    As strontium ranelate appears to improve clinical signs and is, furthermore, well tolerated especially in the upper gastrointestinal region, this treatment is expected to result in an improved health-related quality of life (HRQoL). Strontium ranelate thus offers significant clinical benefits in terms of efficacy, tolerability, and ease of administration in the treatment of postmenopausal women with vertebral osteoporotic fractures." A very postiive study of Protelos.

    www.ncbi.nlm.nih.gov/entrez/query

Protelos reduces vertebral fractures

  • "Prevention of vertebral fractures by strontium ranelate in postmenopausal women with osteoporosis." by Compston J. Department of Medicine, Box 157, Addenbrooke's Hospital, Hills Road, Cambridge,UK. Osteoporos Int. 2005 Jan;16 Suppl 1:S4-6.

    ABSTRACT: "The antifracture efficacy of strontium ranelate, a compound with a novel mechanism of action on bone, has been assessed in two large, randomized, controlled trials conducted in postmenopausal women. Strontium ranelate was given at a daily dose of 2 g, and all women received calcium and vitamin D supplements. In women with established osteoporosis there was a 41% reduction in vertebral fractures over 3 years' treatment [relative risk (RR) 0.59; 95% confidence interval (CI) 0.48-0.73; P<0.001]; significant reductions were also seen after only 1 year of treatment.

    The beneficial effect was also seen for clinical vertebral fractures: over 3 years there was a significant reduction in new clinical vertebral fractures (RR 0.62; 95% CI 0.47-0.83; P<0.001); this reduction was also observed during the first year of treatment (RR 0.48; 95% CI 0.29-0.80; P=0.003). Over the 3-year treatment period significantly fewer patients had height loss and fewer patients reported new or worsening back pain in the treated group than in the control group. These results demonstrate that strontium ranelate is a new therapeutic option in the prevention of osteoporotic vertebral fractures in postmenopausal women."

    www.ncbi.nlm.nih.gov/entrez/query

A second study about Protelos and vertebral fractures: Protelos

  • "The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis." by Meunier PJ, Roux C, Seeman E, Ortolani S, Badurski JE, Spector TD, Cannata J, Balogh A, Lemmel EM, Pors-Nielsen S, Rizzoli R, Genant HK, Reginster JY. Department of Rheumatology and Bone Diseases, Edouard Herriot Hospital, Lyons, France.

    SUMMARY: "Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption. In a phase 2 clinical trial, strontium ranelate, an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption, has been shown to reduce the risk of vertebral fractures and to increase bone mineral density.

    METHODS: To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial, we randomly assigned 1649 postmenopausal women with osteoporosis (low bone mineral density) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years. We gave calcium and vitamin D supplements to both groups before and during the study. Vertebral radiographs were obtained annually, and measurements of bone mineral density were performed every six months.

    RESULTS: New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group, with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period (relative risk, 0.59; 95 percent confidence interval, 0.48 to 0.73). Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck (P<0.001 for both comparisons). There were no significant differences between the groups in the incidence of serious adverse events. CONCLUSIONS: Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures. Copyright 2004 Massachusetts Medical Society."

    www.ncbi.nlm.nih.gov/entrez/query.

Protelos reduces non-vertebral fractures.

  • "Strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) study." by Reginster JY, Seeman E, De Vernejoul MC, Adami S, Compston J, Phenekos C, Devogelaer JP, Curiel MD, Sawicki A, Goemaere S, Sorensen OH, Felsenberg D, Meunier PJ. Department of Epidemiology, Public Health and Health Economics, University of Liege, Belgium.

    SUMMARY: "Strontium ranelate, a new oral drug shown to reduce vertebral fracture risk in postmenopausal women with osteoporosis, was studied in the Treatment of Peripheral Osteoporosis (TROPOS) study to assess its efficacy and safety in preventing nonvertebral fractures also.

    METHODS: Strontium ranelate (2 g/d) or placebo were randomly allocated to 5091 postmenopausal women with osteoporosis in a double-blind placebo-controlled 5-yr study with a main statistical analysis over 3 yr of treatment.

    FINDINGS: In the entire sample, relative risk (RR) was reduced by 16% for all nonvertebral fractures (P = 0.04), and by 19% for major fragility fractures (hip, wrist, pelvis and sacrum, ribs and sternum, clavicle, humerus) (P = 0.031) in strontium ranelate-treated patients in comparison with the placebo group. Among women at high risk of hip fracture (age > or = 74 yr and femoral neck bone mineral density T score < or = -3, corresponding to -2.4 according to NHANES reference) (n = 1977), the RR reduction for hip fracture was 36% (P = 0.046). RR of vertebral fractures was reduced by 39% (P < 0.001) in the 3640 patients with spinal x-rays and by 45% in the subgroup without prevalent vertebral fracture. Strontium ranelate increased bone mineral density throughout the study, reaching at 3 yr (P < 0.001): +8.2% (femoral neck) and +9.8% (total hip). Incidence of adverse events (AEs) was similar in both groups. CONCLUSION: This study shows that strontium ranelate significantly reduces the risk of all nonvertebral and in a high-risk subgroup, hip fractures over a 3-yr period, and is well tolerated. It confirms that strontium ranelate reduces vertebral fractures. Strontium ranelate offers a safe and effective means of reducing the risk of fracture associated with osteoporosis."

    www.ncbi.nlm.nih.gov/entrez/query.

To read basic information about Protelos, and a FAQ about Protelos go to Strontium Ranelate : Protelos - or you can read about additional Osteoporosis, Osteopenia Treatments .

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