OsteopeniaNCT00935935
Study of Bone Disease in Older HIV-infected Adults
An observational study of Osteopenia and Osteoporosis, run by Ruth M. Rothstein CORE Center at 1 site in United States.
Trial summary
This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteopenia, Osteoporosis, HIV Infection
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 HIV-infected adults, age 50 years or older, on HAART with undetectable viral loads, who are randomly sampled from 6 strata defined by ethnicity (Black:White:Hispanic; 2:1:1) and sex (male:female; 1:1). 100 HIV+ adults, age ≥ 50 yr (50 ♂, 50 ♀; 50 AA, 25 W, 25 H).
Who may be able to join
- HIV-1 infection documented by ELISA and confirmed by western blot
- Treatment with antiretroviral drugs for at least 12 months
- Age 50-70 years
- CD4 count > 350 cells/mm3 for at least 6 months
- HIV-RNA undetectable (< 75 copies/ml for at least 6 months)
Who cannot join
- Known bone disease (primary or metastatic malignancy, osteomalacia)
- Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D [> 800 IU daily]).
Trial locations and contacts
1 site in 1 country.
United States1 site
Ruth M Rothstein CORE Center
Chicago, Illinois, 60612
About this study
Official title: A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults
This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones.
The purposes of this study are:
- to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center
- to see what are the common causes of bone disease in older HIV infected persons
- to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.
- Conditions
- Osteopenia, Osteoporosis, HIV Infection, Aging, HIV Infections
- Keywords
- Treatment experienced
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, HIV Infections
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 older than 50 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables
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 posted9 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruth M. Rothstein CORE Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, oluwatoyin M. Adeyemi, Ruth M. Rothstein CORE Center
- Investigators
- Oluwatoyin Adeyemi, MD, Principal investigator, Ruth M. Rothstein CORE Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935935
- Sponsor's protocol ID
- Bone2009
- Status last verified
- Aug 2012
- First submitted
- 8 Jul 2009
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults
- ClinicalTrials.gov ID
- NCT00935935
- Acronym / sponsor ID
- Bone2009
- Conditions
- Osteopenia, Osteoporosis, HIV Infection, Aging, HIV Infections
- Keywords
- Treatment experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ruth M. Rothstein CORE CenterUniversity, hospital or other
- Collaborators
- Rush University Medical Center, Merck Sharp & Dohme LLC
- Study start
- Dec 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Jul 2009 (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 study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones.
The purposes of this study are:
- to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center
- to see what are the common causes of bone disease in older HIV infected persons
- to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV older than 50 years | – | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 HIV-infected adults, age 50 years or older, on HAART with undetectable viral loads, who are randomly sampled from 6 strata defined by ethnicity (Black:White:Hispanic; 2:1:1) and sex (male:female; 1:1). 100 HIV+ adults, age ≥ 50 yr (50 ♂, 50 ♀; 50 AA, 25 W, 25 H).
Key inclusion criteria (5 listed)
- HIV-1 infection documented by ELISA and confirmed by western blot
- Treatment with antiretroviral drugs for at least 12 months
- Age 50-70 years
- CD4 count > 350 cells/mm3 for at least 6 months
- HIV-RNA undetectable (< 75 copies/ml for at least 6 months)
Key exclusion criteria (2 listed)
- Known bone disease (primary or metastatic malignancy, osteomalacia)
- Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D [> 800 IU daily]).
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
Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables
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 3 Aug 2012.
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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.
Oluwatoyin Adeyemi, MD principal investigator
Ruth M. Rothstein CORE Center
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 Osteopenia and Osteoporosis, run by Ruth M. Rothstein CORE Center at 1 site in United States.
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 5 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 3 Aug 2012. 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 United States. 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?
Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables (time frame: 6 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 3 Aug 2012.