Bone DensityNCT02827643
Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz
A study testing TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement and TDF/3TC or FTC/EFV in people with Bone Density, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Density
- What is being tested?
- TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement and TDF/3TC or FTC/EFV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-1-infected patients who start 3TC or FTC,TDF and EFV within 3 months before enrollment
- Age 18-50 years
Who cannot join
- CrCl <60mL/min/1.73 m2 ¶-
- CaCO3 supplement >500 mg/day or vitamin D supplement >800 IU/day
- Steroid used (equivalent to prednisolone> 5 mg/day more than 3 months )
- Osteoporosis treatment
- Serum Ca >10.5 g/dL
- History fragility fracture
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- Pregnancy or breastfeeding
- Secondary amenorrhea
- Hyperthyroidism
- History of kidney stone
- Current active opportunistic infection
Trial locations and contacts
1 site in 1 country.
Sasisopin Kiertiburanakul, M.D.MHS contact
Thailand1 site, 1 recruiting
- Recruiting
Patawee Boontanondha
Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400
Patawee Boontanondha, M.D., 669-1774-6012, pataweeb44@gmail.com
Sasisopin Sasisopin Kiertiburanakul, MD, MHS, 662-201-0033
About this study
Official title: Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz: An Open-label, Randomized Controlled Trial
The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate.
Read the detailed description
Early initiation of antiretroviral therapy (ART) has transformed HIV infection into chronic manageable disease. Although incidence of AIDS-related mortality has decreased, it has increased for other co-morbid conditions including decrease bone mass, osteoporosis, fragility fracture. There are multi-factorial that contribute to bone loss in HIV-infected individuals including HIV virus itself that shift bone remodeling pathway toward bone resorption, lifestyle and behavioral factors, co-morbid conditions and ART.
Initiation of ART is associated with 2%-6% reduction in bone mineral density during the first 2 years of treatment regardless of ART regimens and then stabilization thereafter in the majority of the study. This magnitude of bone loss is similar to postmenopausal women during the first year.
Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue reverse transcriptase inhibitor, has been associated with greater bone loss than other reverse transcriptase inhibitors, that is recommended as the first line treatment in Thailand. Nonetheless there is an evidence in western country that calcium and vitamin D supplement can attenuate bone loss in naive HIV-infected individual who start ART with TDF. Even though many experts recommend to avoid TDF and prefer abacavir, NRTIs which affect bone loss less than other NRTIs, in high fracture risk patients, more than less HIV-infected-patients can access to abacavir in resource limiting country. This research aims to study bone mineral density (BMD) in HIV infected-patient in Thai population who receive tenofovir with calcium and vitamin D supplement.
- Conditions
- Bone Density
- Being tested
- TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement, TDF/3TC or FTC/EFV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDF/3TC or FTC/EFV plus Calcium and vitamin D supplementDrug
Also called ergocalciferol
Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study
TDF/3TC or FTC/EFVOther
arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.
| Study group | Role | What they receive |
|---|---|---|
| TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement | Active comparator | Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study Receives: Drug: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement |
| TDF/3TC or FTC/EFV | Other | the subjects in this arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient. Receives: Other: TDF/3TC or FTC/EFV |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change of bone density
Measured: 24 weeks
Secondary outcomes (1)
change in 25(OH)D level
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827643
- Sponsor's protocol ID
- ID 01-59-11 ว
- Status last verified
- Jun 2016
- First submitted
- 6 Jul 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz: An Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02827643
- Acronym / sponsor ID
- ID 01-59-11 ว
- Conditions
- Bone Density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Jul 2016 (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.
The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate.
Detailed description
Early initiation of antiretroviral therapy (ART) has transformed HIV infection into chronic manageable disease. Although incidence of AIDS-related mortality has decreased, it has increased for other co-morbid conditions including decrease bone mass, osteoporosis, fragility fracture. There are multi-factorial that contribute to bone loss in HIV-infected individuals including HIV virus itself that shift bone remodeling pathway toward bone resorption, lifestyle and behavioral factors, co-morbid conditions and ART.
Initiation of ART is associated with 2%-6% reduction in bone mineral density during the first 2 years of treatment regardless of ART regimens and then stabilization thereafter in the majority of the study. This magnitude of bone loss is similar to postmenopausal women during the first year.
Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue reverse transcriptase inhibitor, has been associated with greater bone loss than other reverse transcriptase inhibitors, that is recommended as the first line treatment in Thailand. Nonetheless there is an evidence in western country that calcium and vitamin D supplement can attenuate bone loss in naive HIV-infected individual who start ART with TDF. Even though many experts recommend to avoid TDF and prefer abacavir, NRTIs which affect bone loss less than other NRTIs, in high fracture risk patients, more than less HIV-infected-patients can access to abacavir in resource limiting country. This research aims to study bone mineral density (BMD) in HIV infected-patient in Thai population who receive tenofovir with calcium and vitamin D supplement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement | Active comparator | Drug: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplementOnce daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study |
| TDF/3TC or FTC/EFV | Other | Other: TDF/3TC or FTC/EFVthe subjects in this arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HIV-1-infected patients who start 3TC or FTC,TDF and EFV within 3 months before enrollment
- Age 18-50 years
Key exclusion criteria (11 listed)
- CrCl <60mL/min/1.73 m2 ¶-
- CaCO3 supplement >500 mg/day or vitamin D supplement >800 IU/day
- Steroid used (equivalent to prednisolone> 5 mg/day more than 3 months )
- Osteoporosis treatment
- Serum Ca >10.5 g/dL
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 |
|---|---|---|
| TDF/3TC or FTC/EFV plus Calcium and vitamin D supplementAlso: ergocalciferolOnce daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study | Drug | TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement |
| TDF/3TC or FTC/EFVarm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient. | Other | TDF/3TC or FTC/EFV |
Primary outcome
percentage change of bone density
Time frame: 24 weeks
1 secondary outcome
change in 25(OH)D level
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Individual participant dataSharing planned: Yes
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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.
Sasisopin Kiertiburanakul, M.D.MHS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement and TDF/3TC or FTC/EFV in people with Bone Density, run by Mahidol University 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patawee Boontanondha, M.D. (669-1774-6012, pataweeb44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage change of bone density (time frame: 24 weeks). 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 11 Jul 2016.