Weight LossINVESTNCT04076618
Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)
A study testing Vest, Resistance Exercise Training and weight loss program in people with Weight Loss and Bone Health, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The main goal of the proposed study is to compare the effects of weight loss (WL) alone with WL plus weighted vest use or WL plus resistance exercise training (RT) on indicators of bone health and subsequent fracture risk. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Weight Loss, Bone Health
- What is being tested?
- Vest, Resistance Exercise Training and weight loss program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 1 Apr 2024
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-85 years
- BMI=30-40 kg/m^2 or BMI 27.0-<30.0 kg/m^2 plus one risk factor
- Weight stability - no weight loss > 5% in past 6 months
- No contraindications for safe and optimal participation in exercise training/vest use.
- Approved for participation by Study Coordinator
- Willing to provide informed consent; agree to all study procedures and assessments; Able to provide own transit to assessment/intervention visits
- Willing to complete online/electronic study forms and participate in virtual group sessions, as needed.
Who cannot join
- Weight greater than 450 lbs
- Dependent on cane or walker: >2 falls (injurious on non-injurious) in past year
- Any contraindications for participation in voluntary weight loss
- Smoker (>1 cigarette/d or 4/wk within yr); Excessive alcohol use (>14 drinks/wk)
- Participation in regular resistance training and/or high intensity/high impact aerobic exercise for >60 mins per day on > 5 days/week for the past 6 months
- Evidence of cognitive impairment (MoCA<20)
Show all 26Show fewer
- Osteoporosis (self-report and on prescription medication, T-score < or = -2.5 on total hip, femoral neck, lumbar spine or distal radius scan at screening visit, or fracture risk assessment tool (FRAX) 10-year risk scores >3% for hip fracture or >20% for major osteoporotic fracture (TBS adjusted FRAX is preferable if available)
- Self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height)
- Chronic back/shoulder/knee pain with current or past (within 1 year) prescription medication use for at least 3 months
- Severe, diagnosed arthritis (osteoarthritis, rheumatoid arthritis, or gout) with current or past (within 1 year) prescription medication use for at least 3 months
- Past (ever) or planned (next 12 months) back surgery
- Past (6 months prior) or planned (next 12 months) joint replacement surgery; or past (ever) unilateral or bilateral hip replacement surgery
- Past (ever) metal device or fixation in the hip, pelvis, or femur
- Uncontrolled hypertension (BP > 160/90 mmHg)
- Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen, neurological or hematological disease requiring treatment for at least 3 months in past year
- Cancer requiring treatment in past year, except non-melanoma skin cancer
- Low Vitamin D (<20 ng/mL)
- Abnormal kidney or liver function (2x upper limits of normal)
- estimated glomerular filtration rate (eGFR)<45 mL/min/1.73m2,
- Anemia (Hb <13 g/dL in men/<12 g/dL in women)
- Uncontrolled diabetes (fasting glucose > 140 mg/dL)
- Regular use of: growth hormones, weight loss medications, oral steroids, insulin, or prescription osteoporosis medications in the past year
- No home computer, laptop or tablet with reliable home internet OR no smartphone (touch-screen enabled phone) with reliable unlimited mobile internet
- Involved in another behavioral/interventional research study, weight loss program, or undergoing physical therapy.
- Unable to tolerate diet, vest, or CT scan (claustrophobia)
- Judged unsuitable for the trial for any reason by clinic staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
The main goal of the proposed study is to compare the effects of weight loss (WL) alone with WL plus weighted vest use or WL plus resistance exercise training (RT) on indicators of bone health and subsequent fracture risk.
Read the detailed description
The study team proposes that a 12 month trial in 150 older (60-85 years) adults with obesity (Body mass index or BMI=30-40 kg/m2 OR 27.0-<30 kg/m² and one obesity-related risk factor) randomized to one of three interventions (n=50/group): WL alone (WL; caloric restriction targeting 10% WL); WL plus weighted vest use (WL+Vest); targeting ≥8 hours/day, weight replacement titrated up to 10% WL); or, WL plus structured RT (WL+RT; 3 days/week). Total hip trabecular volumetric bone mineral density (vBMD) is the primary outcome. This outcome will be complemented by exploratory assessment of several fracture-related risk factors, including: (1) femoral neck and lumbar spine vBMD, cortical thickness, finite element modeling of bone strength, and regional fat and muscle volumes, measured by CT; (2) areal bone mineral density (aBMD) at the total hip, femoral neck, lumbar spine, and distal radius; trabecular bone score; and total body fat/lean masses, measured by dual energy x-ray absorptiometry (DXA); (3) muscle function and strength; (4) biomarkers of bone turnover; and (5) bone-regulating hormones/cytokines known to influence bone metabolism during WL. Therefore, the investigators Specific Aims are to:
Aim 1: Determine the effects of WL+Vest compared to WL and WL+RT on 12 month change in total hip trabecular vBMD. Despite similar reductions in total body weight, Hypothesis 1: Participants in the WL+Vest group will show attenuated losses of total hip trabecular vBMD versus WL; and Hypothesis 2: Loss in total hip trabecular vBMD will be no greater in WL+Vest compared to WL+RT.
Aim 2: Explore the effects of WL+Vest compared to WL and WL+RT on the 12 month change in fracture-related risk factors. Despite similar reductions in total body weight, we hypothesize that WL+Vest and WL+RT will demonstrate improvements in fracture-related risk factors compared to WL.
- Conditions
- Weight Loss, Bone Health
- Being tested
- Vest, Resistance Exercise Training, weight loss program
- Keywords
- nutrition, vest
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VestDevice
Weighted Vest worn > or = 8 hours per day
Resistance Exercise TrainingBehavioural
Structured exercise training 3 days a week
weight loss programBehavioural
a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss plus Vest | Experimental | Not described Receives: Device: Vest; Behavioral: weight loss program |
| Weight Loss Plus Resistance Exercise Training | Active comparator | Not described Receives: Behavioral: Resistance Exercise Training; Behavioral: weight loss program |
| Weight Loss | Active comparator | Not described Receives: Behavioral: weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Measured: 12 months from baseline
Secondary outcomes (19)
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Measured: 6 months from baseline
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Measured: 6 months from baseline
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Measured: 12 months from baseline
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Measured: 6 months from baseline
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Measured: 12 months from baseline
Change in Trabecular Bone Score (TBS)
measurement taken during dual energy x-ray absorptiometry (DXA) scan; Trabecular Bone Score is a measure of bone architecture that has been shown to be an independent risk factor for fracture. The measure is unitless, and ranges from 1.0-1.6, where an elevated TBS greater than or equal to 1.3 appears to represent strong, fracture-resistant bone architecture, while a low TBS less than or equal to 1.2 reflects weak, fracture-prone bone architecture.
Measured: 6 months from baseline
Change in Trabecular Bone Score (TBS)
measurement taken during dual energy x-ray absorptiometry (DXA) scan; Trabecular Bone Score is a measure of bone architecture that has been shown to be an independent risk factor for fracture. The measure is unitless, and ranges from 1.0-1.6, where an elevated TBS greater than or equal to 1.3 appears to represent strong, fracture-resistant bone architecture, while a low TBS less than or equal to 1.2 reflects weak, fracture-prone bone architecture.
Measured: 12 months from baseline
Change in Total Hip Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 6 months from baseline
Change in Total Hip Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 12 months from baseline
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 6 months from baseline
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 12 months from baseline
Change in Distal Radius Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 6 months from baseline
Change in Distal Radius Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 12 months from baseline
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 6 months from baseline
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Measured: 12 months from baseline
Change in Total Body Fat Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA) scan
Measured: 6 months from baseline
Change in Total Body Fat Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA) scan
Measured: 12 months from baseline
Change in Total Body Lean Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA)
Measured: 6 months from baseline
Change in Total Body Lean Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA)
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start12 Aug 2020
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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 (4)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Beavers, PhD, MPH, RD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076618
- Sponsor's protocol ID
- IRB00058279
- Acronym
- INVEST
- Status last verified
- Apr 2024
- First submitted
- 29 Aug 2019
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Beavers DP, Roe LS, Li Y, Dobrosky KL, Janssen I, Beavers KM. Compositional Data Analysis of Relative Body Mass and Physical Function Using the Relative Shift Approach. Obesity (Silver Spring). 2026 Oct 6. doi: 10.1002/oby.70307. Online ahead of print.
PubMed 42838929Beavers KM, Lynch SD, Fanning J, Howard M, Lawrence E, Lenchik L, Shapses SA, Weaver AA, Wherry SJ, Zamora Z, Nicklas BJ, Beavers DP. Weighted Vest Use or Resistance Exercise to Offset Weight Loss-Associated Bone Loss in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2516772. doi: 10.1001/jamanetworkopen.2025.16772.
PubMed 40540267Beavers KM, Avery AE, Shankaran M, Evans WJ, Lynch SD, Dwyer C, Howard M, Beavers DP, Weaver AA, Lenchik L, Cawthon PM. Application of the D3 -creatine muscle mass assessment tool to a geriatric weight loss trial: A pilot study. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):2350-2358. doi: 10.1002/jcsm.13322. Epub 2023 Sep 5.
PubMed 37668075Miller RM, Beavers DP, Cawthon PM, Crotts C, Fanning J, Gerosa J, Greene KA, Hsieh KL, Kiel J, Lawrence E, Lenchik L, Lynch SD, Nesbit BA, Nicklas BJ, Weaver AA, Beavers KM. Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods. Contemp Clin Trials. 2021 May;104:106326. doi: 10.1016/j.cct.2021.106326. Epub 2021 Feb 22.
PubMed 33631359
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)
- ClinicalTrials.gov ID
- NCT04076618
- Acronym / sponsor ID
- INVEST / IRB00058279
- Conditions
- Weight Loss, Bone Health
- Keywords
- nutrition, vest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the proposed study is to compare the effects of weight loss (WL) alone with WL plus weighted vest use or WL plus resistance exercise training (RT) on indicators of bone health and subsequent fracture risk.
Detailed description
The study team proposes that a 12 month trial in 150 older (60-85 years) adults with obesity (Body mass index or BMI=30-40 kg/m2 OR 27.0-<30 kg/m² and one obesity-related risk factor) randomized to one of three interventions (n=50/group): WL alone (WL; caloric restriction targeting 10% WL); WL plus weighted vest use (WL+Vest); targeting ≥8 hours/day, weight replacement titrated up to 10% WL); or, WL plus structured RT (WL+RT; 3 days/week). Total hip trabecular volumetric bone mineral density (vBMD) is the primary outcome. This outcome will be complemented by exploratory assessment of several fracture-related risk factors, including: (1) femoral neck and lumbar spine vBMD, cortical thickness, finite element modeling of bone strength, and regional fat and muscle volumes, measured by CT; (2) areal bone mineral density (aBMD) at the total hip, femoral neck, lumbar spine, and distal radius; trabecular bone score; and total body fat/lean masses, measured by dual energy x-ray absorptiometry (DXA); (3) muscle function and strength; (4) biomarkers of bone turnover; and (5) bone-regulating hormones/cytokines known to influence bone metabolism during WL. Therefore, the investigators Specific Aims are to:
Aim 1: Determine the effects of WL+Vest compared to WL and WL+RT on 12 month change in total hip trabecular vBMD. Despite similar reductions in total body weight, Hypothesis 1: Participants in the WL+Vest group will show attenuated losses of total hip trabecular vBMD versus WL; and Hypothesis 2: Loss in total hip trabecular vBMD will be no greater in WL+Vest compared to WL+RT.
Aim 2: Explore the effects of WL+Vest compared to WL and WL+RT on the 12 month change in fracture-related risk factors. Despite similar reductions in total body weight, we hypothesize that WL+Vest and WL+RT will demonstrate improvements in fracture-related risk factors compared to WL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight Loss plus Vest | Experimental | Device: Vest, Behavioral: weight loss program |
| Weight Loss Plus Resistance Exercise Training | Active comparator | Behavioral: Resistance Exercise Training, Behavioral: weight loss program |
| Weight Loss | Active comparator | Behavioral: weight loss program |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60-85 years
- BMI=30-40 kg/m^2 or BMI 27.0-<30.0 kg/m^2 plus one risk factor
- Weight stability - no weight loss > 5% in past 6 months
- No contraindications for safe and optimal participation in exercise training/vest use.
- Approved for participation by Study Coordinator
Key exclusion criteria (26 listed)
- Weight greater than 450 lbs
- Dependent on cane or walker: >2 falls (injurious on non-injurious) in past year
- Any contraindications for participation in voluntary weight loss
- Smoker (>1 cigarette/d or 4/wk within yr); Excessive alcohol use (>14 drinks/wk)
- Participation in regular resistance training and/or high intensity/high impact aerobic exercise for >60 mins per day on > 5 days/week for the past 6 months
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 |
|---|---|---|
| VestWeighted Vest worn > or = 8 hours per day | Device | Weight Loss plus Vest |
| Resistance Exercise TrainingStructured exercise training 3 days a week | Behavioural | Weight Loss Plus Resistance Exercise Training |
| weight loss programa 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes) | Behavioural | Weight Loss, Weight Loss Plus Resistance Exercise Training, Weight Loss plus Vest |
Primary outcome
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
Time frame: 12 months from baseline
measured in mg/cm3 during computed tomography (CT) scan
19 secondary outcomes
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
Time frame: 6 months from baseline
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
Time frame: 6 months from baseline
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
Time frame: 12 months from baseline
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
Time frame: 6 months from baseline
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
Time frame: 12 months from baseline
Change in Trabecular Bone Score (TBS)
Time frame: 6 months from baseline
Change in Trabecular Bone Score (TBS)
Time frame: 12 months from baseline
Change in Total Hip Areal Bone Mineral Density (aBMD)
Time frame: 6 months from baseline
Change in Total Hip Areal Bone Mineral Density (aBMD)
Time frame: 12 months from baseline
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
Time frame: 6 months from baseline
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
Time frame: 12 months from baseline
Change in Distal Radius Areal Bone Mineral Density (aBMD)
Time frame: 6 months from baseline
Change in Distal Radius Areal Bone Mineral Density (aBMD)
Time frame: 12 months from baseline
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
Time frame: 6 months from baseline
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
Time frame: 12 months from baseline
Change in Total Body Fat Mass (kg)
Time frame: 6 months from baseline
Change in Total Body Fat Mass (kg)
Time frame: 12 months from baseline
Change in Total Body Lean Mass (kg)
Time frame: 6 months from baseline
Change in Total Body Lean Mass (kg)
Time frame: 12 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42838929Beavers DP, Roe LS, Li Y, Dobrosky KL, Janssen I, Beavers KM. Compositional Data Analysis of Relative Body Mass and Physical Function Using the Relative Shift Approach. Obesity (Silver Spring). 2026 Oct 6. doi: 10.1002/oby.70307. Online ahead of print.
- Derived from this study: PubMed 40540267Beavers KM, Lynch SD, Fanning J, Howard M, Lawrence E, Lenchik L, Shapses SA, Weaver AA, Wherry SJ, Zamora Z, Nicklas BJ, Beavers DP. Weighted Vest Use or Resistance Exercise to Offset Weight Loss-Associated Bone Loss in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2516772. doi: 10.1001/jamanetworkopen.2025.16772.
- Derived from this study: PubMed 37668075Beavers KM, Avery AE, Shankaran M, Evans WJ, Lynch SD, Dwyer C, Howard M, Beavers DP, Weaver AA, Lenchik L, Cawthon PM. Application of the D3 -creatine muscle mass assessment tool to a geriatric weight loss trial: A pilot study. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):2350-2358. doi: 10.1002/jcsm.13322. Epub 2023 Sep 5.
- Derived from this study: PubMed 33631359Miller RM, Beavers DP, Cawthon PM, Crotts C, Fanning J, Gerosa J, Greene KA, Hsieh KL, Kiel J, Lawrence E, Lenchik L, Lynch SD, Nesbit BA, Nicklas BJ, Weaver AA, Beavers KM. Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods. Contemp Clin Trials. 2021 May;104:106326. doi: 10.1016/j.cct.2021.106326. Epub 2021 Feb 22.
- 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.
Kristen Beavers, PhD, MPH, RD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vest, Resistance Exercise Training and weight loss program in people with Weight Loss and Bone Health, run by Wake Forest University Health Sciences at 1 site in United States.
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 7 inclusion and 26 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 6 Feb 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2025). 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?
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) (time frame: 12 months from baseline). 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 NCT04076618, which also lists 4 linked publications.
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 6 Feb 2025.