Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese

Overview

In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Full Title of Study: “Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2017

Detailed Description

Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%). Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Arms, Groups and Cohorts

  • Alendronate
    • Patients treated with alendronate
  • Minodronate
    • Patients treated with minodronate
  • Denosmab
    • Patients treated with denosmab

Clinical Trial Outcome Measures

Primary Measures

  • Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment
    • Time Frame: Up to 36 months
    • The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment. We investigate changes in BMD and bone turnover markers.

Participating in This Clinical Trial

Inclusion Criteria

  • severe osteoporotic patients Exclusion Criteria:

  • cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tomidahama Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Toshihiko Kono, Head of Hospital – Tomidahama Hospital
  • Overall Official(s)
    • Rui Niimi, MD, PhD, Study Director, Tomidahama Hospital
  • Overall Contact(s)
    • Rui Niimi, MD, PhD, (81)-59-365-0023, furikakefuri@hotmail.co.jp

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