Efficacy of Oral Ibandronate in Osteoporosis

Phase 2

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: Ibandronate; Drug: Oral Ibandronate and Vitamin D

• Registration Number: NCT03186131
• Lead Sponsor: Shinshu University

Brief Summary

There has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin D

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2017-10-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Primary Completion: 2022-12-08
• Study Completion: 2025-06-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Osteoporotic patients who want to take oral ibandronate

Exclusion Criteria

• Patients who are allergic to oral ibandronate or vitamin D Patients who have not taken oral ibandronate for the last 2 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Ibandronate alone	Ibandronate	Monthly Oral Intake of Ibandronate
Oral Ibandronate and Vitamin D	Oral Ibandronate and Vitamin D	Monthly oral intake of Ibandronate and daily oral intake of Vitamin D

Primary Outcome Measures

Name	Time	Method
Bone mineral density	Change from Baseline Values at 1 year

Trial Locations

Locations (1)

Yukio Nakamura; 🇯🇵 Matsumoto, Nagano, Japan