Effects of ospemifene and raloxifene on biochemical markers of bone turnover in postmenopausal women

Janne Komi, Kari S. Lankinen, Michael DeGregorio, Jorma Heikkinen, Seppo Saarikoski, Marjo Tuppurainen, Kaija Halonen, Risto Lammintausta, Kalervo Väänänen, Olavi Ylikorkala, Risto Erkkola

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Abstract

Ospemifene is a novel selective estrogen receptor modulator (SERM) that is initially being developed for the treatment of vaginal atrophy in postmenopausal women. However, it also shows promise in the prevention and treatment of osteoporosis. As a part of a phase II trial, we compared the effects of ospemifene and raloxifene on bone turnover in postmenopausal women. The study was conducted as a randomized, double-blind study in which 118 healthy postmenopausal women received 30 (n = 29), 60 (n = 30), or 90 mg (n = 30) ospemifene or 60 mg (n = 29) raloxifene for 3 months. Bone resorption was assessed by measuring the urinary outputs of N- and C-terminal cross-linking telopeptides of type I collagen (NTX and CTX, respectively). Bone formation was assessed by measuring bone-specific alkaline phosphatase (bone ALP), osteocalcin (OC), procollagen type I N propeptide (PINP), and procollagen type I C propeptide (PICP) in serum. All markers were studied before and at 3 months and 2-4 weeks after cessation of the medication. Urine NTX outputs decreased in all study groups, and the only statistically significant difference in NTX was observed between raloxifene and 30∈mg ospemifene, which was reduced more in the raloxifene group. The output of CTX decreased most clearly in 60- and 90-mg ospemifene groups, but no significant differences between study groups emerged. A significant difference was found between the 90-mg ospemifene group and raloxifene in PINP in favor of ospemifene. No other differences in bone formation markers emerged between ospemifene and raloxifene. The study confirms the bone-restoring activity of ospemifene, which is comparable to that of raloxifene.

Original languageEnglish (US)
Pages (from-to)314-318
Number of pages5
JournalJournal of Bone and Mineral Metabolism
Volume24
Issue number4
DOIs
StatePublished - Jul 2006

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Keywords

  • Ospemifene
  • Osteoporosis
  • Postmenopausal
  • Raloxifene
  • SERM

ASJC Scopus subject areas

  • Endocrinology

Cite this

Komi, J., Lankinen, K. S., DeGregorio, M., Heikkinen, J., Saarikoski, S., Tuppurainen, M., Halonen, K., Lammintausta, R., Väänänen, K., Ylikorkala, O., & Erkkola, R. (2006). Effects of ospemifene and raloxifene on biochemical markers of bone turnover in postmenopausal women. Journal of Bone and Mineral Metabolism, 24(4), 314-318. https://doi.org/10.1007/s00774-006-0689-9