Efficacy of Oral Ibandronate in Osteoporosis

Sponsor

Shinshu University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03186131

Collaborator

(none)

100

Enrollment

Location

Arms

91.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Ibandronate Drug: Oral Ibandronate and Vitamin D	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Examination of Bone Metabolism and Bone Mineral Density in Primary and Secondary Osteoporosis Treated by Oral Ibandronate

Actual Study Start Date :

Oct 12, 2017

Anticipated Primary Completion Date :

Dec 8, 2022

Anticipated Study Completion Date :

Jun 8, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral Ibandronate alone Monthly Oral Intake of Ibandronate	Drug: Ibandronate To examine the efficacy of oral Ibandronate in osteoporosis
Active Comparator: Oral Ibandronate and Vitamin D Monthly oral intake of Ibandronate and daily oral intake of Vitamin D	Drug: Oral Ibandronate and Vitamin D To examine the efficacy of oral Ibandronate and Vitamin D in osteoporosis

Arm

Intervention/Treatment

Active Comparator: Oral Ibandronate alone

Monthly Oral Intake of Ibandronate

Drug: Ibandronate

To examine the efficacy of oral Ibandronate in osteoporosis

Active Comparator: Oral Ibandronate and Vitamin D

Monthly oral intake of Ibandronate and daily oral intake of Vitamin D

Drug: Oral Ibandronate and Vitamin D

To examine the efficacy of oral Ibandronate and Vitamin D in osteoporosis

Outcome Measures

Primary Outcome Measures

Bone mineral density [Change from Baseline Values at 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yukio Nakamura	Matsumoto	Nagano	Japan	3908621

Sponsors and Collaborators

Shinshu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yukio Nakamura, Associate professor at Shinshu University, Shinshu University

ClinicalTrials.gov Identifier:

NCT03186131

Other Study ID Numbers:

Oral IBN2017

First Posted:

Jun 14, 2017

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoporosis

Vitamin D

Ibandronic Acid

Study Results

No Results Posted as of Sep 21, 2021