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CompletedNCT02635997Updated Apr 8, 2024

Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America

An observational study in Osteoporosis, sponsored by Pontifical Catholic University of Argentina. Completed at 1 site in Argentina. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Pontifical Catholic University of Argentina · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
425
Ages
21 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 22 studies in Osteoporosis with a site in Argentina — 1 open to participants now, 2 under way, none of them phase 3. Osteoporosis · Argentina.

Started
2013
the only one that year
Observational
3 of 22
1 open now
Registered
20th of 22
by date

Among the 22 studies in Osteoporosis with a site in Argentina, this one is the only one that started in 2013, is one of 3 observational ones, and was the 20th registered.

Osteoporosis

1,602 studies on the registry are indexed under Osteoporosis; 210 are open to participants now.

Browse Osteoporosis studies →

Open to participants now

1 of the 22 studies in Osteoporosis with a site in Argentina is open now. Recruiting first, the newest first:

A study can be open while its sites in Argentina have not opened yet or have stopped. Only those recruiting at a site in Argentina →

Who these studies take

Of the 133 Osteoporosis studies recruiting now, 77 (58%) set no upper age limit and 20 (15%) stop at 75 or younger; 9 take children under 18; 36 take healthy volunteers.

This study: 21 Years and older · female · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Osteoporosis

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Keywords

  • osteoporosis
  • ibandronate
  • vitamine D
  • calcium
  • bone mineral density
  • health-related quality of life
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Osteoporosis due to secondary causes
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
425 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Drugantiresorptive therapy
06

What researchers measure

Primary outcomes

  1. Bone Mineral Density

    Time frame: 6 months

  2. Health-Related Quality of Life

    Time frame: 6 months

Secondary outcomes

  1. Adverse Events

    Time frame: 6 months

07

Study locations

1 site
  • Catholic University
    Buenos Aires, Argentina
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2013, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2015
First posted
Dec 21, 2015
Start
Jan 2013
Primary completionActual
Jun 2015
CompletionActual
Jun 2015
Last update
Apr 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02635997
Lead sponsor
Pontifical Catholic University of Argentina
Responsible party
Santiago Perez Lloret (Associate Researcher, Pontifical Catholic University of Argentina) — Principal investigator
First posted
Dec 21, 2015
Start date
Jan 2013
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Apr 8, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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