Vertebral FracturesFractaVIHNCT02131571
Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years
An observational study of Vertebral Fractures, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Fractures
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2014to 15 Jun 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected patients older than 50 years
Who may be able to join
- Age above 50 years
- HIV infection
Who cannot join
- Pregnancy
- Receiving corticosteroids or antiresorptive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years: Importance of Bone Mineral Density and Bone Biomarkers
Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years.
Read the detailed description
To determine the prevalence of asymptomatic vertebral fractures in HIV patients older than 50 years, and the risk of fracture during a follow up of 2 years, according to bone mineral density at inclusion, the level of serum bone biomarkers, and the presence of secondary factors such as hypovitaminosis D or/and secondary hyperparathyroidism.
- Conditions
- Vertebral Fractures
- Keywords
- HIV, bone, fractures, vitamin D, biomarkers
- Medical subject headings
- Spinal Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV patients older than 50 years | HIV infected patients older than 50 years in current follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vertebral fractures in HIV patients older than 50 years
To determine by lumbar and thoracic x ray the presence of vertebral fractures and the changes in vertebral form or size, according to Genant methods
Measured: 2 years
Secondary outcomes (2)
Risk of vertebral alteration according to bone mineral density and serum biomarkers
To determine the relationships of vertebral alterations with bone mineral density by dual X-ray absorptiometry
Measured: 2 years
Vertebral alterations during follow up
To determine the emergence of vertebral alterations during 2 years of follow up according to bone mineral density, bone biomarkers (osteocalcin, beta-crosslaps), and vitamin D/parathyroid hormone (PTH) status.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start30 Jun 2014
- Primary completion30 Mar 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FracturesStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose L Casado, MD, Principal investigator, Ramon y Cajal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131571
- Sponsor's protocol ID
- FractaVIH 117/13
- Other IDs
- EC 117/13
- Acronym
- FractaVIH
- Status last verified
- Jun 2018
- First submitted
- 2 May 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years: Importance of Bone Mineral Density and Bone Biomarkers
- ClinicalTrials.gov ID
- NCT02131571
- Acronym / sponsor ID
- FractaVIH / FractaVIH 117/13
- Conditions
- Vertebral Fractures
- Keywords
- HIV, bone, fractures, vitamin D, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 6 May 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.
Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years.
Detailed description
To determine the prevalence of asymptomatic vertebral fractures in HIV patients older than 50 years, and the risk of fracture during a follow up of 2 years, according to bone mineral density at inclusion, the level of serum bone biomarkers, and the presence of secondary factors such as hypovitaminosis D or/and secondary hyperparathyroidism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV patients older than 50 years | – | –HIV infected patients older than 50 years in current follow up |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients older than 50 years
Key inclusion criteria (2 listed)
- Age above 50 years
- HIV infection
Key exclusion criteria (2 listed)
- Pregnancy
- Receiving corticosteroids or antiresorptive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of vertebral fractures in HIV patients older than 50 years
Time frame: 2 years
To determine by lumbar and thoracic x ray the presence of vertebral fractures and the changes in vertebral form or size, according to Genant methods
2 secondary outcomes
Risk of vertebral alteration according to bone mineral density and serum biomarkers
Time frame: 2 years
Vertebral alterations during follow up
Time frame: 2 years
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 2 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jose L Casado, MD principal investigator
Ramon y Cajal Hospital
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 Vertebral Fractures, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 2 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 2 Jul 2018. 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 Spain. 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?
Prevalence of vertebral fractures in HIV patients older than 50 years (time frame: 2 years). 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 2 Jul 2018.