Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 20 to 120

Evaluating new treatments for osteoporosis after denosumab therapy in Japanese patients

Official title: Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

Run by Shinshu University · NCT03755193 · Data updated 2026-11-12

This study tests different treatment options for Japanese patients with osteoporosis who have been on denosumab for two years to see which one works best and is safe to use for another two years.

More Osteoporosis trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages20 Years to 120 Years
SexAll
Enrollment90 (estimated)
SponsorShinshu University
Academic / other
Drugs / interventionsdenosumab
Locations1 site (Matsumoto, Nagano)
StatusRecruiting
StartedNovember 24, 2018
Main results expectedNovember 23, 2024
Study endsNovember 23, 2026
Registry record updatedSeptember 21, 2021
Trial IDNCT03755193 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are Japanese patients diagnosed with osteoporosis who have completed two years of denosumab therapy.

Probably not a fit

Patients who are not diagnosed with osteoporosis, have allergies to the study drugs, are pregnant, or refuse participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of different anti-resorption drugs in Japanese patients with osteoporosis who have previously undergone two years of denosumab therapy. Participants will be divided into three groups, receiving either SERM and eldecalcitol, bisphosphonates and eldecalcitol, or solely eldecalcitol for an additional 24 months. The study aims to assess both the effectiveness of these treatments and any adverse events that may arise during the treatment period.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for osteoporosis patients who have completed denosumab therapy.

How similar studies have gone: While there have been studies on osteoporosis treatments, this specific approach of evaluating post-denosumab therapy options is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* osteoporosis patients

Exclusion Criteria:

* not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Where it's running

  • Yukio Nakamura
    Matsumoto, Nagano, Japan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.