NCT02635997

Brief Summary

Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by several international, randomized, double-blind, controlled trials. These studies have not included patients from central america, to the best of our knowledge. Therefore, this open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and health-related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

December 13, 2015

Last Update Submit

April 4, 2024

Conditions

Osteoporosis

Keywords

osteoporosisibandronatevitamine Dcalciumbone mineral densityhealth-related quality of life

Outcome Measures

Primary Outcomes (2)

  • Bone Mineral Density

    6 months

  • Health-Related Quality of Life

    6 months

Secondary Outcomes (1)

  • Adverse Events

    6 months

Study Arms (1)

patients on antiresorptive therapy

Ibandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day

Drug: antiresorptive therapy

Interventions

antiresorptive therapyDRUG
patients on antiresorptive therapy

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal women with a diagnosis of osteoporosis o with a high risk of developing it in the near future.

You may qualify if:

  • Women with a diagnosis of osteoporosis of at-Risk
  • Have a medical indication to receive Ibandronate+Vitamine D+Calcium

You may not qualify if:

  • Osteoporosis due to secondary causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Researcher

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 21, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations

AR(1)