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Effect of denosumab administration on low bone mineral density (T-score −1.0 to −2.5) in postmenopausal Japanese women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer

  • Katsuhiko Nakatsukasa
  • Hiroshi Koyama
  • Yoshimi Ouchi
  • Kouichi Sakaguchi
  • Yoshifumi Fujita
  • Takayuki Matsuda
  • Makoto Kato
  • Eiichi Konishi
  • Tetsuya Taguchi
Original Article

Abstract

Although adjuvant aromatase inhibitor (AI) therapy is widely used in postmenopausal women with hormone receptor-positive breast cancer, it is known to be associated with bone loss and increased fracture risk. Denosumab, a fully human monoclonal antibody against the receptor activator of nuclear factor-κB ligand, has been shown to protect against AI-induced bone loss. However, the efficacy of denosumab in the treatment of AI-associated bone loss has not been prospectively evaluated in Japan. We prospectively monitored bone mineral density (BMD) of the lumbar spine and bilateral femoral necks in 100 postmenopausal women with hormone receptor-positive postoperative breast cancer of clinical stage I–IIIA in whom treatment with AI as adjuvant endocrine therapy was planned or had been ongoing. Study participants received supplemental calcium and vitamin D every day and denosumab (60 mg) subcutaneously every 6 months. At enrollment, patients were required to have evidence of low bone mass without meeting the criteria for osteoporosis. The primary endpoint was percentage change from baseline in lumbar spine BMD at month 12. At 6 and 12 months, lumbar spine BMD increased by 3.3 and 4.7%, respectively. BMD of the femoral necks also increased. Hypocalcemia of grade ≥2, osteonecrosis of the jaw, and non-traumatic clinical fracture did not occur. In conclusion, semi-annual treatment with denosumab was associated with increased BMD in Japanese women receiving adjuvant AI therapy, regardless of prior AI treatment.

Keywords

Breast cancer Aromatase inhibitor Denosumab Bone mineral density 

Notes

Compliance with ethical standards

Conflict of interest

All authors declare that they have no conflict of interest.

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Copyright information

© The Japanese Society for Bone and Mineral Research and Springer Japan KK 2017

Authors and Affiliations

  • Katsuhiko Nakatsukasa
    • 1
  • Hiroshi Koyama
    • 2
  • Yoshimi Ouchi
    • 1
  • Kouichi Sakaguchi
    • 1
  • Yoshifumi Fujita
    • 1
  • Takayuki Matsuda
    • 3
  • Makoto Kato
    • 4
  • Eiichi Konishi
    • 5
  • Tetsuya Taguchi
    • 1
  1. 1.Department of Endocrine and Breast SurgeryKyoto Prefectural University of MedicineKyotoJapan
  2. 2.Nara City HospitalNaraJapan
  3. 3.Saiseikai Kyoto HospitalKyotoJapan
  4. 4.Kato Breast Surgery ClinicShigaJapan
  5. 5.Department of Surgical PathologyKyoto Prefectural University of MedicineKyotoJapan

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