Evaluating new treatments for osteoporosis after denosumab therapy in Japanese patients
Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 120 Years |
| Sex | All |
| Sponsor | Shinshu University Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Matsumoto, Nagano) |
| Trial ID | NCT03755193 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese patients diagnosed with osteoporosis who have completed two years of denosumab therapy.
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.
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 performed: While there have been studies on osteoporosis treatments, this specific approach of evaluating post-denosumab therapy options is relatively novel.
Eligibility criteria
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 this trial is running
Matsumoto, Nagano
- Yukio Nakamura — Matsumoto, Nagano, Japan (Recruiting)
Study contacts
- Study coordinator: Yukio Nakamura
- Email: yxn14@aol.jp
- Phone: +81263372576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.