OsteopeniaBHVDNCT01634607
Bone Health and Vitamin D Status
An observational study of Osteopenia and Vitamin D Deficiency, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as well as effects of TDF on the patients' bone among HIV positive and negative patients. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Vitamin D Deficiency, HIV Infection
- How many people
- 235 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2019to 16 Feb 2023
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants are from the Anonymous Clinic of the Thai Red Cross AIDS Research Centre (TRC-ARC, the HIV Netherlands Australia Thailand Research Collaboration (HIVNAT) and Queen Savang Vadhana Memorial Hospital (QSV).
Who may be able to join
- HIV uninfected:
- HIV negative confirmed by HIV testing
- Age 30 years and older
- Thai nationality
- Signed informed consent form for the study
- HIV-infected, HAART naïve:
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- Recorded HIV infection
- Age 30 years and older
- Thai nationality
- Signed informed consent form for the study
- HIV-infected, HAART group:
- Recorded HIV infection
- Age 30 years and older
- Thai nationality
- HAART naïve at baseline, planned to start HAART within 90 days. Past exposure to antiretroviral therapy during pregnancy for the prevention of mother to child transmission of HIV ≥ 3 months prior to screening will be allowed
- Signed informed consent form for the study
Who cannot join
- HIV uninfected
- Currently pregnant or lactating
- Recent hospitalization
- Use of anticonvulsants, steroids or vitamin D supplements
- HIV-infected, HAART naïve
- CD4 < 350
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- Currently pregnant/lactating
- Recent hospitalization
- Signs of wasting
- Use of anticonvulsants, steroids or vitamin D supplements
- HIV-infected, HAART group:
- Prior antiretroviral therapy use
- Currently pregnant/lactating
- Recent hospitalization
- Signs of wasting
- Active opportunistic infection
- Use of anticonvulsants, steroids or vitamin D supplements
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330
About this study
Official title: Bone Health and Vitamin D Status in Thai HIV-1 Infected and Uninfected Adults (A Substudy of TNT-HIV 003: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study)
This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as well as effects of TDF on the patients' bone among HIV positive and negative patients.
Read the detailed description
To determine the prevalence of osteopenia and vitamin D deficiency in HIV-1 infected, HAART naive Thai patients compared to HIV-1 uninfected Thai participants. Furthermore, to determine the change in BMD after twelve months in HIV-1 infected Thai patients on a TDF-based HAART regimen compared to patients on a non-TDF containing regimen.
- Conditions
- Osteopenia, Vitamin D Deficiency, HIV Infection
- Keywords
- osteopenia, vitamin D deficiency, HIV-infected patients, bone health, Bone mineral density (BMD), HIV-uninfected patients, effects of TDF on the patients' bone
- Medical subject headings
- Bone Diseases, Metabolic, Vitamin D Deficiency, 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 uninfected | HIV negative patients | |
| HIV-infected, HAART naïve, high CD4 count | HIV positive patients with high CD4 and not on HIV treatment | |
| HIV-infected with planned to start HAART group | HIV positive patients who will start HIV treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
osteopenia
development of osteopenia
Measured: 60 months
vitamin D deficiency
development of vitamin D deficiency
Measured: 60 months
BMD
changes of BMD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study start1 Dec 2019
- Primary completion15 Jul 2021
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, HIV Netherlands Australia Thailand Research Collaboration, Bamrasnaradura Infectious Diseases Institute, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Sponsor
- Investigators
- Praphan Phanuphak, MD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634607
- Sponsor's protocol ID
- TNT-HIV 003.1
- Acronym
- BHVD
- Status last verified
- Oct 2021
- First submitted
- 2 Jul 2012
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Han WM, Wattanachanya L, Apornpong T, Jantrapakde J, Avihingsanon A, Kerr SJ, Teeratakulpisarn N, Jadwattanakul T, Chaiwatanarat T, Buranasupkajorn P, Ramautarsing R, Phanuphak N, Sunthornyothin S, Ruxrungtham K, Phanuphak P; TNT 003.1 study team. Bone mineral density changes among people living with HIV who have started with TDF-containing regimen: A five-year prospective study. PLoS One. 2020 Mar 25;15(3):e0230368. doi: 10.1371/journal.pone.0230368. eCollection 2020.
PubMed 32210458
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health and Vitamin D Status in Thai HIV-1 Infected and Uninfected Adults (A Substudy of TNT-HIV 003: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study)
- ClinicalTrials.gov ID
- NCT01634607
- Acronym / sponsor ID
- BHVD / TNT-HIV 003.1
- Conditions
- Osteopenia, Vitamin D Deficiency, HIV Infection
- Keywords
- osteopenia, vitamin D deficiency, HIV-infected patients, bone health, Bone mineral density (BMD), HIV-uninfected patients, effects of TDF on the patients' bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- ViiV Healthcare, HIV Netherlands Australia Thailand Research Collaboration, Bamrasnaradura Infectious Diseases Institute, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 6 Jul 2012 (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 compare and assess the prevalence of osteopenia and vitamin D deficiency as well as effects of TDF on the patients' bone among HIV positive and negative patients.
Detailed description
To determine the prevalence of osteopenia and vitamin D deficiency in HIV-1 infected, HAART naive Thai patients compared to HIV-1 uninfected Thai participants. Furthermore, to determine the change in BMD after twelve months in HIV-1 infected Thai patients on a TDF-based HAART regimen compared to patients on a non-TDF containing regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV uninfected | – | –HIV negative patients |
| HIV-infected, HAART naïve, high CD4 count | – | –HIV positive patients with high CD4 and not on HIV treatment |
| HIV-infected with planned to start HAART group | – | –HIV positive patients who will start HIV treatment |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants are from the Anonymous Clinic of the Thai Red Cross AIDS Research Centre (TRC-ARC, the HIV Netherlands Australia Thailand Research Collaboration (HIVNAT) and Queen Savang Vadhana Memorial Hospital (QSV).
Key inclusion criteria (16 listed)
- HIV uninfected:
- HIV-infected, HAART naïve:
- HIV-infected, HAART group:
Key exclusion criteria (17 listed)
- HIV uninfected
- HIV-infected, HAART naïve
- HIV-infected, HAART group:
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
osteopenia
Time frame: 60 months
development of osteopenia
vitamin D deficiency
Time frame: 60 months
development of vitamin D deficiency
BMD
Time frame: 1 year
changes of BMD
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 17 Feb 2023.
- Derived from this study: PubMed 32210458Han WM, Wattanachanya L, Apornpong T, Jantrapakde J, Avihingsanon A, Kerr SJ, Teeratakulpisarn N, Jadwattanakul T, Chaiwatanarat T, Buranasupkajorn P, Ramautarsing R, Phanuphak N, Sunthornyothin S, Ruxrungtham K, Phanuphak P; TNT 003.1 study team. Bone mineral density changes among people living with HIV who have started with TDF-containing regimen: A five-year prospective study. PLoS One. 2020 Mar 25;15(3):e0230368. doi: 10.1371/journal.pone.0230368. eCollection 2020.
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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.
Praphan Phanuphak, MD principal investigator
Thai Red Cross AIDS Research Centre
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 Vitamin D Deficiency, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
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 16 inclusion and 17 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 17 Feb 2023. 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 Thailand. 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?
osteopenia (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01634607, which also lists 1 linked publication.
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 17 Feb 2023.