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Title of Journal: Osteoporos Int

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Abbravation: Osteoporosis International

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Publisher

Springer London

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ISSN

1433-2965

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A doubleblind randomized Phase III multicenter

Authors: K B Hoover C G Miller N C Galante C B Langman
Publish Date: 2015/05/09
Volume: 26, Issue: 10, Pages: 2441-2447
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Abstract

This study compared the effects of pediatric acne treatment with two isotretinoin formulations on bone mineral density We demonstrated no difference in the effect of the two formulations No effect on pediatric bone mineral density was identified for either formulationIsotretinoin 13cisretinoic acid is a treatment for recalcitrant nodular acne with a purported effect on bone mineral density BMD The side effects of isotretinoin on vertebral bone were evaluated to assess the safety of a new FDAapproved isotretinoin formulation Lidoseisotretinoin CipIsoThis doubleblind randomized phase III active control parallelgroup multicenter study compared the safety efficacy and noninferiority of CIPIso to a marketed reference product Accutane® in severe recalcitrant nodular acne subjects Three hundred fiftyeight pediatric male and female subjects aged between 12 and 17 years underwent 20 weeks of treatment with PA lumbar spine dual Xray absorptiometry DXA measurements obtained for bone mineral density BMD and Zscores 55 months apart on visits 1 and 8 One hundred sixtyeight of 358 subjects had height adjusted Zscores HAZ calculatedThere was no difference in the least squares LS mean Zscore or HAZ of the two drugs at visit 1 or 8 The mean and LS mean Zscore and HAZ were greater than zero at visits 1 and 8 for both drugs The change in the LS mean spine Zscore but not HAZ between visits was statistically significant for both drugs There was a mean increase in BMD g/cm2 for both products between visitsThere is no difference in the effect of two formulations of isotretinoin on spine bone density after 6 months of treatment BMD increased and the small change in spine Zscore over treatment disappeared after height adjustment Mean positive Zscores and HAZ in the study were likely due to the exclusion of low and inclusion of high Zscore subjectsKevin B Hoover was a consultant for BioClinica Inc on this study Colin G Miller and Nicholas C Galante were employees of BioClinica Inc at the time the study was performed Craig B Langman declares he has no conflict of interest This study was sponsored by Cipher Pharmaceuticals Inc

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  2. Morbidity following lower extremity fractures in men with spinal cord injury
  3. DXA-based hip structural analysis of once-weekly bisphosphonate-treated postmenopausal women with low bone mass
  4. Effects of 25-hydroxyvitamin D level and its change on parathyroid hormone in premenopausal Chinese women
  5. Thalassemia bone disease: the association between nephrolithiasis, bone mineral density and fractures
  6. Evaluation of three risk assessment tools in discriminating fracture status among Chinese patients undergoing hemodialysis
  7. Oral bisphosphonates and risk of ischemic stroke: a case–control study
  8. The association between serum osteocalcin levels and metabolic syndrome in Koreans
  9. Place of residence and risk of fracture in older people: a population-based study of over 65-year-olds in Cardiff
  10. Fracture risk and adjuvant hormonal therapy among a population-based cohort of older female breast cancer patients
  11. Cost-utility of long-term strontium ranelate treatment for postmenopausal osteoporotic women
  12. Effects of therapeutic exercise for persons with osteoporotic vertebral fractures: a systematic review
  13. Genetic analysis of serum osteocalcin and bone mineral in multigenerational Afro-Caribbean families
  14. Effect of hospitalist consultation on treatment of osteoporosis in hip fracture patients
  15. Declining incidence of low-trauma knee fractures in elderly women: nationwide statistics in Finland between 1970 and 2006
  16. Changing health behaviors with social marketing
  17. Selective protein depletion impairs bone growth and causes liver fatty infiltration in female rats: prevention by Spirulina alga
  18. The vertebral fracture cascade in osteoporosis: a review of aetiopathogenesis
  19. Clinical performance of osteoporosis risk assessment tools in women aged 67 years and older
  20. Osteoporosis and venous thromboembolism: a retrospective cohort study in the UK General Practice Research Database
  21. One year outcomes and costs following a vertebral fracture
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  23. Classification of women with and without hip fracture based on quantitative computed tomography and finite element analysis
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  25. The relationship of vitamin D status to bone mineral density in an Italian population of postmenopausal women
  26. Effects of a combined alendronate and calcitriol agent (Maxmarvil®) on bone metabolism in Korean postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study
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  42. Treatment with acetaminophen/paracetamol or ibuprofen alleviates post-dose symptoms related to intravenous infusion with zoledronic acid 5 mg
  43. Serum sclerostin: the missing link in the bone-vessel cross-talk in hemodialysis patients?
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  48. Discriminative value of FRAX for fracture prediction in a cohort of Chinese postmenopausal women
  49. Effects of alendronate and vitamin D in patients with normocalcemic primary hyperparathyroidism
  50. Stroke in relation to use of raloxifene and other drugs against osteoporosis
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  52. The relationship between low bone mass and metabolic syndrome in Korean women
  53. Effect of high-dose cholecalciferol (vitamin D 3 ) on bone and body composition in children and young adults with HIV infection: a randomized, double-blind, placebo-controlled trial
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  55. Treatment of osteoporosis after alendronate or risedronate
  56. Vertebral anti-fracture efficacy of strontium ranelate according to pre-treatment bone turnover
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  68. Decreased serum sclerostin levels in patients with primary hyperparathyroidism: a cross-sectional and a longitudinal study
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