Bone LossPhase 4BONE:STARNCT03916328
BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study
A Phase 4 study testing B/F/TAF, TDF/3TC/EFV or DTG or NVP and DMPA in people with Bone Loss, run by MU-JHU CARE at 1 site in Uganda.
Trial summary
The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Bone Loss
- What is being tested?
- B/F/TAF, TDF/3TC/EFV or DTG or NVP and DMPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUganda
- Study dates
- 3 Dec 2019to 31 Mar 2024
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 through 40 years (inclusive) at screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and to take part in the study.
- Able and willing to provide adequate locator information, as defined in site SOPs
- Previously participated in the BONE: CARE study. Additional women will be recruited from the health centers where the BONE: CARE participants were receiving HIV care, and these will be matched to those from the BONE: CARE cohort based on age, duration on ART and contraception use.
- Per participant report, plans to stay in the study catchment area in the next 24 months
- Per participant report, willing to continue using similar contraceptive method as in the BONE: CARE study.
Who cannot join
- Currently pregnant/ breastfeeding or was pregnant/ breastfeeding in the last 6 months prior to screening
- Intentions to get pregnant in the next two years
- History of active tuberculosis
- Pathologic bone fracture not related to trauma (ever)
- Has pre-existing condition known to affect bone metabolism (e.g. thyrotoxicosis, tuberculosis, diabetes mellitus, liver or renal disease)
- Is taking the following medications known to interfere with bone metabolism (steroids, anti-convulsants, bisphosphonates, cancer drugs, etc.).
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
MU-JHU Care Limited
Kampala, +256
Flavia Kiweewa Matovu, MBChB, MSc, +256414541044, fmatovu@mujhu.org
About this study
Official title: A Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women on Depo-provera and Tenofovir Disoproxil Fumurate Switched to Tenofovir Alafenamide Fumarate Based Anti-Retroviral Therapy
The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).
- Conditions
- Bone Loss
- Being tested
- B/F/TAF, TDF/3TC/EFV or DTG or NVP, DMPA
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Also called Biktarvy®)
A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
TDF/3TC/EFV or DTG or NVPDrug
A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART.
DMPAOther
Also called Depo-provera
Two thirds of the women will be on DMPA for contraception.
| Study group | Role | What they receive |
|---|---|---|
| DMPA+ and TDF+ | Active comparator | HIV-infected women on DMPA, and TDF containing ART. Receives: Drug: TDF/3TC/EFV or DTG or NVP; Other: DMPA |
| DMPA+ and B/F/TAF+ | Experimental | HIV-infected women on DMPA, and B/F/TAF. Receives: Drug: B/F/TAF; Other: DMPA |
| DMPA- and B/F/TAF+ | Experimental | HIV-infected women on non hormonal contraception, and B/F/TAF. Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density
We will assess percent change in BMD among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART
Measured: 2 years
Changes in trabeculae bone score (TBS)
We will assess percent change in TBS among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART
Measured: 2 years
Secondary outcomes (1)
Changes in bone biomarkers
We will compare changes in bone turnover markers (CTX and P1NP) in B/F/TAF switchers with and without DMPA use
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 posted16 Apr 2019
- Study start3 Dec 2019
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MU-JHU CARE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Kiweewa Matovu, MU-JHU CARE
- Investigators
- Flavia Kiweewa Matovu, MBChB, MSc, Principal investigator, MU-JHU CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916328
- Sponsor's protocol ID
- CO-EU-380-5327
- Acronym
- BONE:STAR
- Status last verified
- Apr 2023
- First submitted
- 19 Oct 2018
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women on Depo-provera and Tenofovir Disoproxil Fumurate Switched to Tenofovir Alafenamide Fumarate Based Anti-Retroviral Therapy
- ClinicalTrials.gov ID
- NCT03916328
- Acronym / sponsor ID
- BONE:STAR / CO-EU-380-5327
- Conditions
- Bone Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- MU-JHU CAREUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 16 Apr 2019 (actual)
- 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 primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DMPA+ and TDF+ | Active comparator | Drug: TDF/3TC/EFV or DTG or NVP, Other: DMPAHIV-infected women on DMPA, and TDF containing ART. |
| DMPA+ and B/F/TAF+ | Experimental | Drug: B/F/TAF, Other: DMPAHIV-infected women on DMPA, and B/F/TAF. |
| DMPA- and B/F/TAF+ | Experimental | Drug: B/F/TAFHIV-infected women on non hormonal contraception, and B/F/TAF. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20 through 40 years (inclusive) at screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and to take part in the study.
- Able and willing to provide adequate locator information, as defined in site SOPs
- Previously participated in the BONE: CARE study. Additional women will be recruited from the health centers where the BONE: CARE participants were receiving HIV care, and these will be matched to those from the BONE: CARE cohort based on age, duration on ART and contraception use.
- Per participant report, plans to stay in the study catchment area in the next 24 months
Key exclusion criteria (6 listed)
- Currently pregnant/ breastfeeding or was pregnant/ breastfeeding in the last 6 months prior to screening
- Intentions to get pregnant in the next two years
- History of active tuberculosis
- Pathologic bone fracture not related to trauma (ever)
- Has pre-existing condition known to affect bone metabolism (e.g. thyrotoxicosis, tuberculosis, diabetes mellitus, liver or renal disease)
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 |
|---|---|---|
| B/F/TAFAlso: Biktarvy®)A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®). | Drug | DMPA+ and B/F/TAF+, DMPA- and B/F/TAF+ |
| TDF/3TC/EFV or DTG or NVPA third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART. | Drug | DMPA+ and TDF+ |
| DMPAAlso: Depo-proveraTwo thirds of the women will be on DMPA for contraception. | Other | DMPA+ and B/F/TAF+, DMPA+ and TDF+ |
Primary outcome
Changes in bone mineral density
Time frame: 2 years
We will assess percent change in BMD among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART
Changes in trabeculae bone score (TBS)
Time frame: 2 years
We will assess percent change in TBS among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART
1 secondary outcome
Changes in bone biomarkers
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Flavia Kiweewa Matovu, MBChB, MSc principal investigator
MU-JHU CARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing B/F/TAF, TDF/3TC/EFV or DTG or NVP and DMPA in people with Bone Loss, run by MU-JHU CARE at 1 site in Uganda.
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 6 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 7 Apr 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 Uganda. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Judith Mbanza, MA (+256414541044, jmbanza@mujhu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bone mineral density (time frame: 2 years). The study lists 2 primary outcomes in all. 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 7 Apr 2023.