OsteoporosisPhase 4BEINGNCT02815566
Bone Health in Aging HIV Infected Women
A Phase 4 study testing tenofovir-alafenamide-emtricitabine and tenofovir-emtricitabine in people with Osteoporosis and HIV, run by University Health Network, Toronto at 7 sites in 2 countries.
Trial summary
Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Osteoporosis, HIV, Menopause
- What is being tested?
- tenofovir-alafenamide-emtricitabine and tenofovir-emtricitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Sep 2017to 25 Feb 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Biological female aged 40-60
- Documented HIV-1 infection
- Peri-menopausal ( as documented by history).
- Signed Informed Consent Form and willing to comply with the protocol.
- Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir or raltegravir or elvitegravir) in combination with TDF-FTC for > 24 weeks.
- Stable viral suppression (plasma HIV-RNA<50 copies/mL for > 24 weeks). Single viral blip <500/ml allowed if re-suppresses.
- If of childbearing potential, is using effective birth control methods and is willing to continue during the trial.
- Women will be assessed for vitamin D and calcium dietary intake; if inadequate for age, supplements will be recommended.
Who cannot join
- HIV-2
- High 10-year fracture risk at baseline ( > 20%) based on country specific FRAX
- Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, strontium
- Current use of systemic steroids ( inhaled steroids permitted) or chemotherapeutic agents
- Acute viral hepatitis
- Chronic hepatitis C with liver transaminases >5 x ULN or expected to require treatment for hepatitis C during the trial period.
Show all 12Show fewer
- Any investigational ARV within 30 days.
- Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
- History of decompensated liver disease (AST or ALT≥5x the upper limit of normal (ULN) or ALT ≥ 3 x ULN and bilirubin ≥ 1.5 x ULN with > 35% direct bilirubin), or the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices.
- Pregnant or breastfeeding
- Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 amylase, creatinine phosphokinase, or lipid elevation.
- Any condition (including illicit drug use or alcohol abuse) or lab results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada5 sites
Hamilton Health Sciences
Hamilton, Ontario, L8S 1A4
McGill University Health Centre
Montreal, Quebec, H4A 3J1
CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
University Health Network
Toronto, Ontario, M5G 2C4
Vancouver ID Research and Care Centre
Vancouver, British Columbia, V6Z 2C7
Italy2 sites
Ospedale San Raffaele
Milan, 20127
Università degli Studi di Modena e Reggio Emilia
Modena, 41124
About this study
Official title: Bone Health in Aging HIV Infected Women: Improvement or Prevention of Changes in Bone Mineral Density by Switching Antiretroviral Agents. Is There an Optimal Time to Intervene?
Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks.
Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). .
Read more
Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96.
Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96.
Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.
Read the detailed description
A Randomized controlled clinical trial (RCT) of immediate vs delayed switch from TDF/FTC to TAF/FTC to define the impact of switching ARV on BMD in different stages of the aging trajectory in HIV infected women. Included is a geriatric assessment based on the conceptualization of health transition across menopause.
Study Hypothesis: The primary hypothesis is that switching from TDF/FTC will improve BMD to a degree that correlates with a lower fracture risk in aging HIV+ women. We will further explore our theory that the impact is greater in those in the early stages of menopause and in those who also receive a protease inhibitor (PI) as the third antiretroviral agent (ARV).
Primary objectives: To determine if: 1. Switching HIV+ women on TDF/FTC to TAF/FTC increases BMD at the spine at 48 weeks relative to those who continue TDF/FTC 2. To determine if any observed improvements continue or stabilize in the year after switch.
Hypothesis generating objectives: To determine if the effect of switching from TDF/FTC to TAF/FTC on BMD varies by stage of menopause and by third ARV.
Study design: This study is double blind placebo controlled randomised, 1:1, multicentre strategic trial. Patients will be randomised to immediate vs delayed switch, with randomization allocation arranged to minimize differences between treatment group with respect to stage of menopause (peri- menopause vs early post menopause) and site. Study population: HIV positive women who are in the peri-menopausal period or those within 10 years post menopause to capture those with greatest risk of BMD loss. As menopause typically occurs earlier in HIV + women we include those aged 45-55 years. They must be on a cART regimen containing TDF/FTC with HIV RNA <50 c/ml for at least 6 months.
Intervention:
- Immediate switch of TDF/FTC to TAF/FTC while maintaining the third ARV agent.
- Delayed switch of TDF/FTC to TAF/FTC at 48 weeks while maintaining the third ARV agent.
Randomization: A computer-generated randomization list will be prepared prior to study onset by a statistician unassociated with the study. Randomization will be stratified by study centre.
Primary endpoint: Comparison of the immediate vs delayed group in the % change from baseline in BMD at the lumbar spine at week 48 and 96.
Secondary endpoints: Will compare changes between the immediate and delayed group from data collected at screening or baseline and weeks 48 and 96.
- change from baseline in BMD at hip Changes in Bone architecture as determined by Trabecular bone scan (TBS) and HRpQCT (high resolution peripheral quantitative computerized tomography) (Toronto site) Changes in 10 year fracture risk determined by country specific FRAX® (fracture risk assessment) calculator
- with HIV-1 RNA <50 c/ml Change from baseline in geriatric functional measures: frailty, performance and balance Change from baseline in muscle quality: Sarcopenia - grip strength measured by a Dynamometer Change from baseline in lipid values and Framingham cardiovascular risk scores Changes in renal tubular and glomerular function: GFR (glomerular filtration rate), Creatinine, urine albumin /creatinine and protein/creatinine, glucosuria Safety (clinical and laboratory adverse events) Changes in biomarkers of inflammation, coagulation and bone metabolism Tolerability (EuroQoL questionnaire)
- Conditions
- Osteoporosis, HIV, Menopause
- Being tested
- tenofovir-alafenamide-emtricitabine, tenofovir-emtricitabine
- Keywords
- kidney, antiretroviral agent, tenofovir, osteoporosis, women
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir-alafenamide-emtricitabineDrug
Also called Descovy
comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
tenofovir-emtricitabineDrug
Also called Truvada
comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
| Study group | Role | What they receive |
|---|---|---|
| Immediate switch | Experimental | Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks Receives: Drug: tenofovir-alafenamide-emtricitabine |
| delayed switch | Active comparator | Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks Receives: Drug: tenofovir-emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic.
Measured: Baseline, 48 weeks and 96 weeks
Secondary outcomes (1)
% Change in Bone Mineral Density From Baseline at the Femoral Neck
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic.
Measured: Baseline, 48 weeks and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start12 Sep 2017
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University Health Network, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, San Raffaele University Hospital, Italy, Gilead Sciences, CIHR Canadian HIV Trials Network
- Responsible party
- Principal investigator, University Health Network-Toronto General Hospital, University Health Network, Toronto
- Investigators
- sharon walmsley, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815566
- Sponsor's protocol ID
- 16-5543
- Other IDs
- IN-CA-311-3963
- Acronym
- BEING
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2016
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information on viral load, toxicity and bone scans will be available to treating physicians
Publications
Walmsley S, Clarke R, Lee T, Singer J, Cheung AM, Smaill F, De Pokomandy A, Trottier S, Messina E, Guaraldi G. BEING: Bone Health in Aging Women with HIV: Impact of Switching Antiretroviral Therapy on Bone Mineral Density During the Perimenopausal Period. AIDS Res Hum Retroviruses. 2023 Apr;39(4):204-210. doi: 10.1089/AID.2022.0106. Epub 2023 Jan 20.
PubMed 36511389
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health in Aging HIV Infected Women: Improvement or Prevention of Changes in Bone Mineral Density by Switching Antiretroviral Agents. Is There an Optimal Time to Intervene?
- ClinicalTrials.gov ID
- NCT02815566
- Acronym / sponsor ID
- BEING / 16-5543
- Conditions
- Osteoporosis, HIV, Menopause
- Keywords
- kidney, antiretroviral agent, tenofovir, osteoporosis, women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, San Raffaele University Hospital, Italy, Gilead Sciences, CIHR Canadian HIV Trials Network
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks.
Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). .
Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96.
Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96.
Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.
Detailed description
A Randomized controlled clinical trial (RCT) of immediate vs delayed switch from TDF/FTC to TAF/FTC to define the impact of switching ARV on BMD in different stages of the aging trajectory in HIV infected women. Included is a geriatric assessment based on the conceptualization of health transition across menopause.
Study Hypothesis: The primary hypothesis is that switching from TDF/FTC will improve BMD to a degree that correlates with a lower fracture risk in aging HIV+ women. We will further explore our theory that the impact is greater in those in the early stages of menopause and in those who also receive a protease inhibitor (PI) as the third antiretroviral agent (ARV).
Primary objectives: To determine if: 1. Switching HIV+ women on TDF/FTC to TAF/FTC increases BMD at the spine at 48 weeks relative to those who continue TDF/FTC 2. To determine if any observed improvements continue or stabilize in the year after switch.
Hypothesis generating objectives: To determine if the effect of switching from TDF/FTC to TAF/FTC on BMD varies by stage of menopause and by third ARV.
Study design: This study is double blind placebo controlled randomised, 1:1, multicentre strategic trial. Patients will be randomised to immediate vs delayed switch, with randomization allocation arranged to minimize differences between treatment group with respect to stage of menopause (peri- menopause vs early post menopause) and site. Study population: HIV positive women who are in the peri-menopausal period or those within 10 years post menopause to capture those with greatest risk of BMD loss. As menopause typically occurs earlier in HIV + women we include those aged 45-55 years. They must be on a cART regimen containing TDF/FTC with HIV RNA <50 c/ml for at least 6 months.
Intervention:
- Immediate switch of TDF/FTC to TAF/FTC while maintaining the third ARV agent.
- Delayed switch of TDF/FTC to TAF/FTC at 48 weeks while maintaining the third ARV agent.
Randomization: A computer-generated randomization list will be prepared prior to study onset by a statistician unassociated with the study. Randomization will be stratified by study centre.
Primary endpoint: Comparison of the immediate vs delayed group in the % change from baseline in BMD at the lumbar spine at week 48 and 96.
Secondary endpoints: Will compare changes between the immediate and delayed group from data collected at screening or baseline and weeks 48 and 96.
- change from baseline in BMD at hip Changes in Bone architecture as determined by Trabecular bone scan (TBS) and HRpQCT (high resolution peripheral quantitative computerized tomography) (Toronto site) Changes in 10 year fracture risk determined by country specific FRAX® (fracture risk assessment) calculator
- with HIV-1 RNA <50 c/ml Change from baseline in geriatric functional measures: frailty, performance and balance Change from baseline in muscle quality: Sarcopenia - grip strength measured by a Dynamometer Change from baseline in lipid values and Framingham cardiovascular risk scores Changes in renal tubular and glomerular function: GFR (glomerular filtration rate), Creatinine, urine albumin /creatinine and protein/creatinine, glucosuria Safety (clinical and laboratory adverse events) Changes in biomarkers of inflammation, coagulation and bone metabolism Tolerability (EuroQoL questionnaire)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate switch | Experimental | Drug: tenofovir-alafenamide-emtricitabineOpen label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks |
| delayed switch | Active comparator | Drug: tenofovir-emtricitabineOpen-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Biological female aged 40-60
- Documented HIV-1 infection
- Peri-menopausal ( as documented by history).
- Signed Informed Consent Form and willing to comply with the protocol.
- Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir or raltegravir or elvitegravir) in combination with TDF-FTC for > 24 weeks.
Key exclusion criteria (12 listed)
- HIV-2
- High 10-year fracture risk at baseline ( > 20%) based on country specific FRAX
- Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, strontium
- Current use of systemic steroids ( inhaled steroids permitted) or chemotherapeutic agents
- Acute viral hepatitis
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 |
|---|---|---|
| tenofovir-alafenamide-emtricitabineAlso: Descovycomparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density | Drug | Immediate switch |
| tenofovir-emtricitabineAlso: Truvadacomparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density | Drug | delayed switch |
Primary outcome
Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
Time frame: Baseline, 48 weeks and 96 weeks
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic.
1 secondary outcome
% Change in Bone Mineral Density From Baseline at the Femoral Neck
Time frame: Baseline, 48 weeks and 96 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36511389Walmsley S, Clarke R, Lee T, Singer J, Cheung AM, Smaill F, De Pokomandy A, Trottier S, Messina E, Guaraldi G. BEING: Bone Health in Aging Women with HIV: Impact of Switching Antiretroviral Therapy on Bone Mineral Density During the Perimenopausal Period. AIDS Res Hum Retroviruses. 2023 Apr;39(4):204-210. doi: 10.1089/AID.2022.0106. Epub 2023 Jan 20.
- Individual participant dataSharing planned: Yes. Information on viral load, toxicity and bone scans will be available to treating physicians
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
sharon walmsley, MD principal investigator
University Health Network, Toronto
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tenofovir-alafenamide-emtricitabine and tenofovir-emtricitabine in people with Osteoporosis and HIV, run by University Health Network, Toronto at 7 sites in 2 countries.
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 8 inclusion and 12 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Italy. 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?
Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine (time frame: Baseline, 48 weeks and 96 weeks). 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 NCT02815566, 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 19 Dec 2024.