OsteoporosisNCT02635997
Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America
An observational study of Osteoporosis, run by Pontifical Catholic University of Argentina at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- antiresorptive therapy
- How many people
- 425 participants
- Where
- 1 siteArgentina
- Study dates
- Jan 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women with a diagnosis of osteoporosis o with a high risk of developing it in the near future.
Who may be able to join
- Women with a diagnosis of osteoporosis of at-Risk
- Have a medical indication to receive Ibandronate+Vitamine D+Calcium
Who cannot join
- Osteoporosis due to secondary causes
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- antiresorptive therapy
- Keywords
- osteoporosis, ibandronate, vitamine D, calcium, bone mineral density, health-related quality of life
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiresorptive therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| patients on antiresorptive therapy | Ibandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day Receives: Drug: antiresorptive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: 6 months
Health-Related Quality of Life
Measured: 6 months
Secondary outcomes (1)
Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifical Catholic University of Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Perez Lloret, Pontifical Catholic University of Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635997
- Sponsor's protocol ID
- Catholic University
- Status last verified
- Apr 2024
- First submitted
- 13 Dec 2015
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America
- ClinicalTrials.gov ID
- NCT02635997
- Acronym / sponsor ID
- Catholic University
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, ibandronate, vitamine D, calcium, bone mineral density, health-related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Pontifical Catholic University of ArgentinaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients on antiresorptive therapy | – | Drug: antiresorptive therapyIbandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with a diagnosis of osteoporosis o with a high risk of developing it in the near future.
Key inclusion criteria (2 listed)
- Women with a diagnosis of osteoporosis of at-Risk
- Have a medical indication to receive Ibandronate+Vitamine D+Calcium
Key exclusion criteria (1 listed)
- Osteoporosis due to secondary causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiresorptive therapy | Drug | patients on antiresorptive therapy |
Primary outcome
Bone Mineral Density
Time frame: 6 months
Health-Related Quality of Life
Time frame: 6 months
1 secondary outcome
Adverse Events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Pontifical Catholic University of Argentina at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.