HIVPhase 2BATARINCT01968850
Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
A Phase 2 study testing alendronate/vitamin D in people with HIV, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- alendronate/vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Apr 2014to 19 Mar 2018
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV-1 infection
- Adult (aged >18 years or as per local guidelines)
- Premenopausal, if female
- Antiretroviral-naïve
- Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formulated as Stribild®)
- Low (<10%) ten-year fracture risk as assessed by the FRAX score validated for Canadian populations
Who cannot join
- Presence of established osteoporosis at baseline as determined by BMD measurement
- Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.)
- Inability to communicate in English
- Creatinine clearance <35 mL/min (using Cockcroft-Gault formula)
- Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation
- Hypocalcemia
Show all 9Show fewer
- Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
- Inability to stand or sit upright for at least 30 minutes
- Pregnancy, active plans to become pregnant, or lactation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms:
- no bone anti-resorptive therapy (standard of care)
- concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;
- a 24 week delay in initiation of a 24 week course of alendronate/vitamin D
Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary objective will involve calculation of σ and ρ using all data; δ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.
- Conditions
- HIV
- Being tested
- alendronate/vitamin D
- Keywords
- osteoporosis, HIV, bone Mineral Density, alendronate, vitamin D
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronate/vitamin DDrug
Also called Fosavance 70/56
once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| no bone anti-resorptive therapy | No intervention | (standard of care) |
| 24-week tx of alendronate/vitamin D | Experimental | Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D Receives: Drug: alendronate/vitamin D |
| Delayed 24-week tx of alendronate/vitamin D | Experimental | a 24 week delay in initiation of a 24 week course of alendronate/vitamin D Receives: Drug: alendronate/vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage changes in BMD at a) the lumbar spine and b) proximal femur
The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.
Measured: 48 weeks
Secondary outcomes (5)
Feasibility
The proportion of patients who are eligible and who consent to participate will be calculated, and the timeliness (rate) of enrollment will be described, to further inform the feasibility of a larger randomized controlled trial.
Measured: 48 weeks
Acceptability
Using standardized questions, participants will be asked about the acceptability of the alendronate therapy (including the experience of pill-taking and the weekly schedule)
Measured: 48 weeks
Safety/Tolerability
As per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Measured: 48 weeks
Adherence
Adherence with anti-resorptive therapy will be assessed by pill count and questionnaire.
Measured: 48 weeks
Bone Biomarkers
Two bone biomarkers will be assessed: cross-linked carboxyterminal-telopeptide (CTX) and aminoterminal propeptide of type 1 collagen (P1NP).
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study start23 Apr 2014
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Responsible party
- Sponsor
- Investigators
- Darrell Tan, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968850
- Sponsor's protocol ID
- CTNPT 021
- Acronym
- BATARI
- Status last verified
- Apr 2018
- First submitted
- 9 Oct 2013
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
- ClinicalTrials.gov ID
- NCT01968850
- Acronym / sponsor ID
- BATARI / CTNPT 021
- Conditions
- HIV
- Keywords
- osteoporosis, HIV, bone Mineral Density, alendronate, vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Study start
- 23 Apr 2014 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 24 Oct 2013 (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 is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms:
- no bone anti-resorptive therapy (standard of care)
- concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;
- a 24 week delay in initiation of a 24 week course of alendronate/vitamin D
Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary objective will involve calculation of σ and ρ using all data; δ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no bone anti-resorptive therapy | No intervention | –(standard of care) |
| 24-week tx of alendronate/vitamin D | Experimental | Drug: alendronate/vitamin DConcomitant initiation of a 24 week course of co-formulated alendronate/vitamin D |
| Delayed 24-week tx of alendronate/vitamin D | Experimental | Drug: alendronate/vitamin Da 24 week delay in initiation of a 24 week course of alendronate/vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV-1 infection
- Adult (aged >18 years or as per local guidelines)
- Premenopausal, if female
- Antiretroviral-naïve
- Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formulated as Stribild®)
Key exclusion criteria (9 listed)
- Presence of established osteoporosis at baseline as determined by BMD measurement
- Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.)
- Inability to communicate in English
- Creatinine clearance <35 mL/min (using Cockcroft-Gault formula)
- Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation
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 |
|---|---|---|
| alendronate/vitamin DAlso: Fosavance 70/56once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks. | Drug | 24-week tx of alendronate/vitamin D, Delayed 24-week tx of alendronate/vitamin D |
Primary outcome
Percentage changes in BMD at a) the lumbar spine and b) proximal femur
Time frame: 48 weeks
The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.
5 secondary outcomes
Feasibility
Time frame: 48 weeks
Acceptability
Time frame: 48 weeks
Safety/Tolerability
Time frame: 48 weeks
Adherence
Time frame: 48 weeks
Bone Biomarkers
Time frame: 48 weeks
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 19 Apr 2018.
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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.
Darrell Tan, MD principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alendronate/vitamin D in people with HIV, run by Unity Health Toronto at 2 sites in Canada.
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 6 inclusion and 9 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 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage changes in BMD at a) the lumbar spine and b) proximal femur (time frame: 48 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 19 Apr 2018.