OsteoporosisNCT02271204
Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis
An observational study of Osteoporosis, run by Clinic of Endocrinology and Metabolic Disorders, Macedonia.
Trial summary
This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Ibandronic acid
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Apr 2014
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with postmenopausal osteoporosis in everyday routine practice from selected centers in R. Macedonia
Who may be able to join
- Patients had post menopausal osteoporosis
- Patients had no contraindication for bisphosphonates
- Patients had been naive for ibandronate therapy
- Patients who have signed informed consent and are willing to share their data for data analysis
Who cannot join
- Is not Ibandronate naïve
- Hypersensitivity to any component of the bisphosphonates Ibandronate;
- Administration of any investigational drug within 30 days preceding the first dose of the study drug.
About this study
Official title: Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial
This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)
- Conditions
- Osteoporosis
- Being tested
- Ibandronic acid
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibandronic acidDrug
Also called Bonviva
As prescribed by physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis
Measured: end of observation 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startMar 2009
- Primary completionApr 2013
- Study completionApr 2014
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
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinic of Endocrinology and Metabolic Disorders, Macedonia
- Sponsor type
- University, hospital or other
- Collaborators
- Clinic for Orthopedic Surgery, Skopje, General Hospital, Kumanovo, General Hospital, Struga, Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271204
- Sponsor's protocol ID
- ML21741
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial
- ClinicalTrials.gov ID
- NCT02271204
- Acronym / sponsor ID
- ML21741
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Clinic of Endocrinology and Metabolic Disorders, MacedoniaUniversity, hospital or other
- Collaborators
- Clinic for Orthopedic Surgery, Skopje, General Hospital, Kumanovo, General Hospital, Struga, Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje
- Study start
- Mar 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Oct 2014 (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.
This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with postmenopausal osteoporosis in everyday routine practice from selected centers in R. Macedonia
Key inclusion criteria (4 listed)
- Patients had post menopausal osteoporosis
- Patients had no contraindication for bisphosphonates
- Patients had been naive for ibandronate therapy
- Patients who have signed informed consent and are willing to share their data for data analysis
Key exclusion criteria (3 listed)
- Is not Ibandronate naïve
- Hypersensitivity to any component of the bisphosphonates Ibandronate;
- Administration of any investigational drug within 30 days preceding the first dose of the study drug.
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 |
|---|---|---|
| Ibandronic acidAlso: BonvivaAs prescribed by physician | Drug | – |
Primary outcome
Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis
Time frame: end of observation 12 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 22 Oct 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Clinic of Endocrinology and Metabolic Disorders, Macedonia.
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 4 inclusion and 3 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 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis (time frame: end of observation 12 months). 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 22 Oct 2014.