NCT02156999

Brief Summary

To examine the changes of bone mineral density and bone turnover markers after Bonviva treatment in osteoporotic patients

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_4

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_4

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 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

8.3 years

First QC Date

June 1, 2014

Last Update Submit

September 20, 2021

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Changes of bone mineral density

    To examine the changes of bone mineral density for the purpose of the effectiveness of the drug

    every 4-6 months

Secondary Outcomes (1)

  • Improvement of bone turnover markers

    Every 3-6 months

Study Arms (1)

Osteoporosis

EXPERIMENTAL
Device: Ibandronic acid, vitamin D

Interventions

Ibandronic acid, vitamin DDEVICE
Osteoporosis

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoporosis

You may not qualify if:

  • Kidney, parathyroid, congenital bone metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Yukio Nakamura, MD, PhD

CONTACT

+81-263-37-2659yxn14@aol.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 1, 2014

First Posted

June 5, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2022

Study Completion

December 1, 2025

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

JP(1)