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Recruiting Phase 2 NCT03755193

NCT03755193 Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

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Clinical Trial Summary
NCT ID NCT03755193
Status Recruiting
Phase Phase 2
Sponsor Shinshu University
Condition Osteoporosis
Study Type INTERVENTIONAL
Enrollment 90 participants
Start Date 2018-11-24
Primary Completion 2024-11-23

Eligibility & Interventions

Sex All sexes
Min Age 20 Years
Max Age 120 Years
Study Type INTERVENTIONAL
Interventions
SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"Bisphosphonates and ELD "Edirol®Tablet 0.75ug"ELD "Edirol®Tablet 0.75ug"

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 90 participants in total. It began in 2018-11-24 with a primary completion date of 2024-11-23.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy: SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months

Eligibility 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

Contact & Investigator

Central Contact

Yukio Nakamura

✉ yxn14@aol.jp

📞 +81263372576

Frequently Asked Questions

Who can join the NCT03755193 clinical trial?

This trial is open to participants of all sexes, aged 20 Years or older, up to 120 Years, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT03755193 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT03755193 currently recruiting?

Yes, NCT03755193 is actively recruiting participants. Contact the research team at yxn14@aol.jp for enrollment information.

Where is the NCT03755193 trial being conducted?

This trial is being conducted at Matsumoto, Japan.

Who is sponsoring the NCT03755193 clinical trial?

NCT03755193 is sponsored by Shinshu University. The trial plans to enroll 90 participants.

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