NCT03186131

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2025

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5.2 years

First QC Date

June 5, 2017

Last Update Submit

September 20, 2021

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    Change from Baseline Values at 1 year

Study Arms (2)

Oral Ibandronate alone

ACTIVE COMPARATOR

Monthly Oral Intake of Ibandronate

Drug: Ibandronate

Oral Ibandronate and Vitamin D

ACTIVE COMPARATOR

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

Drug: Oral Ibandronate and Vitamin D

Interventions

IbandronateDRUG

To examine the efficacy of oral Ibandronate in osteoporosis

Oral Ibandronate alone
Oral Ibandronate and Vitamin DDRUG

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

Oral Ibandronate and Vitamin D

Eligibility Criteria

Age20 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale patients are separately analyzed
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoporotic patients who want to take oral ibandronate

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Ibandronic AcidVitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor at Shinshu University

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 14, 2017

Study Start

October 12, 2017

Primary Completion

December 8, 2022

Study Completion

June 8, 2025

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)