Skeletal Health in Bariatric Surgery Patients

August 14, 2020 updated by: Jayleen M. Grams, University of Alabama at Birmingham
The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

While highly effective both RYGB and SG may lead to increased bone resorption, decreased bone mass, and increased risk of some fractures. Very few studies have compared the effects of the RYGB and the SG on changes skeletal health and findings have been inconsistent. Furthermore, few studies have investigated the short- or long-term consequences of bariatric surgery on bone mineral density in pre- and post-menopausal women. To what extent and how bariatric surgery impacts the skeleton largely remains undetermined. Because estrogen is protective against osteoporosis and fractures, the majority of fractures occur in postmenopausal women. It is important that women have higher rates of obesity (38.3%) compared to men (34.3%) and that ≥67% of bariatric patients are women. Therefore, women may be at a significantly increased risk of developing osteoporosis. These data may help establish clinical guidelines to assess, maintain, and promote skeletal health in the preoperative and postoperative care of bariatric patients; and it may help to determine the appropriate bariatric procedure for women at risk of osteoporosis and fractures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Kirklin Clinic Digestive Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female bariatric surgery population scheduled to undergo Roux en Y Gastric Bypass or Gastric Sleeve Surgery.

Description

Inclusion Criteria:

  • Adult females ≥ 19 years scheduled to undergo bariatric surgery (Roux en Y Gastric Bypass or Gastric Sleeve Surgery)
  • Class II (BMI 35-39.9 kg/m2).
  • Class III obesity (BMI ≥ 40 kg/m2).
  • Scheduled to undergo bariatric surgery with the ability to provide informed consent.

Exclusion Criteria:

  • Patients with a history of thyroid disorders, thyroidectomy and levothyroxine use.
  • Patients with a history of known osteoporosis, steroid-induced osteoporosis, current or previous use of medications for osteoporosis.
  • Patients with a history of gastrointestinal malabsorption.
  • Patients with a history of renal diseases.
  • Patients with a history of current or previous use of corticosteroids.
  • Patients who have used tobacco products within a year of study enrollment.
  • Patients with surgically-induced menopause e.g. bilateral salpingo-oophorectomy.
  • Patients with a history of breast cancer, who have had or are currently on hormonal therapy or anti-hormonal therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Roux en Y Gastric Bypass Pre-menopausal
Pre-menopausal women undergoing Roux en Y Gastric Bypass
Procedure: Roux en Y Gastric Bypass Pre-menopausal
The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
Roux en Y Gastric Bypass Post-menopausal
Post-menopausal women undergoing Roux en Y Gastric Bypass
Procedure: Roux en Y Gastric Bypass Post-menopausal
The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
Sleeve Gastrectomy Pre-menopausal
Pre-menopausal women undergoing Sleeve Gastrectomy
Procedure: Sleeve Gastrectomy Pre-menopausal
The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
Sleeve Gastrectomy Post-menopausal
Post-menopausal women undergoing Gastric Sleeve
Procedure: Sleeve Gastrectomy Post-menopausal
The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.
Time Frame: Baseline
Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density, BMD (in g/cm2) of the lumbar spine (L1-L4), total hip, femoral neck, distal radius, sub-total whole body (excluding only the head), and whole body. T scores will be evaluated and Z scores will be evaluated. T-scores between +1 and -1 is considered normal or healthy, T-scores between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis, T-scores of -2.5 or lower indicates that you have osteoporosis. For premenopausal women under the age of 50, the Z-score is used for diagnosis. Using the criteria defined by the International Society for Clinical Densitometry: If the Z-score is -2.0 or lower, the result will be below the expected range for age. If the Z score is above -2.0, the result is will be defined as within the expected range for age.
Baseline
Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.
Time Frame: Baseline to 12 months
Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density, BMD (in g/cm2) of the lumbar spine (L1-L4), total hip, femoral neck, distal radius, sub-total whole body (excluding only the head), and whole body. T scores will be evaluated and Z scores will be evaluated. T-scores between +1 and -1 is considered normal or healthy, T-scores between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis, T-scores of -2.5 or lower indicates that you have osteoporosis. For premenopausal women under the age of 50, the Z-score is used for diagnosis. Using the criteria defined by the International Society for Clinical Densitometry: If the Z-score is -2.0 or lower, the result will be below the expected range for age. If the Z score is above -2.0, the result is will be defined as within the expected range for age.
Baseline to 12 months
Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.
Time Frame: Baseline to 24 months
Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density, BMD (in g/cm2) of the lumbar spine (L1-L4), total hip, femoral neck, distal radius, sub-total whole body (excluding only the head), and whole body. T scores will be evaluated and Z scores will be evaluated. T-scores between +1 and -1 is considered normal or healthy, T-scores between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis, T-scores of -2.5 or lower indicates that you have osteoporosis. For premenopausal women under the age of 50, the Z-score is used for diagnosis. Using the criteria defined by the International Society for Clinical Densitometry: If the Z-score is -2.0 or lower, the result will be below the expected range for age. If the Z score is above -2.0, the result is will be defined as within the expected range for age.
Baseline to 24 months
Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Baseline
Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)
Baseline
Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Baseline to 12 months
Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)
Baseline to 12 months
Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Baseline to 24 months
Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)
Baseline to 24 months
TBS adjustment of FRAX scores for an enhanced fracture risk probability in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Baseline
The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to fracture risk. Trabecular Bone Score (TBS) software will be used to adjust fracture risk (FRAX) scores to obtain TBS scores (in gradient risk). FRAX adjusted TBS scores (in gradient of risk) ranges from 1.1% -1.9% coefficient of variation (C.V.)
Baseline
TBS adjustment of FRAX scores for an enhanced fracture risk probability in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Change from baseline to 12 months
The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to fracture risk. Trabecular Bone Score (TBS) software will be used to adjust fracture risk (FRAX) scores to obtain TBS scores (in gradient risk). FRAX adjusted TBS scores (in gradient of risk) ranges from 1.1% -1.9% coefficient of variation (C.V.)
Change from baseline to 12 months
TBS adjustment of FRAX scores for an enhanced fracture risk probability in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Change from baseline to 24 months
The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to fracture risk. Trabecular Bone Score (TBS) software will be used to adjust fracture risk (FRAX) scores to obtain TBS scores (in gradient risk). FRAX adjusted TBS scores (in gradient of risk) ranges from 1.1% -1.9% coefficient of variation (C.V.)
Change from baseline to 24 months
TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Baseline
The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. Trabecular Bone Score (TBS) software will be used to assess bone microstructure. TBS ≤1.2 defines degraded microarchitecture, TBS between 1.20 and 1.35 is partially degraded microarchitecture, and TBS ≥1.35 is considered normal.
Baseline
TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Change from baseline to 12 months
The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. Trabecular Bone Score (TBS) software will be used to assess bone microstructure. TBS ≤1.2 defines degraded microarchitecture, TBS between 1.20 and 1.35 is partially degraded microarchitecture, and TBS ≥1.35 is considered normal.
Change from baseline to 12 months
TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
Time Frame: Change from baseline to 24 months
The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. Trabecular Bone Score (TBS) software will be used to assess bone microstructure. TBS ≤1.2 defines degraded microarchitecture, TBS between 1.20 and 1.35 is partially degraded microarchitecture, and TBS ≥1.35 is considered normal.
Change from baseline to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline
Serum bone alkaline phosphatase (BALP in U/L) will be assayed
Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 6 months
Serum bone alkaline phosphatase (BALP in U/L) will be assayed
Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 12 months
Serum bone alkaline phosphatase (BALP in U/L) will be assayed
Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 24 months
Serum bone alkaline phosphatase (BALP in U/L) will be assayed
Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline
Osteocalcin (in ng/mL) will be assayed.
Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 6 months
Osteocalcin (in ng/mL) will be assayed.
Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 12 months
Osteocalcin (in ng/mL) will be assayed.
Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 24 months
Osteocalcin (in ng/mL) will be assayed.
Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline
Type 1 procollagen (P1NP, in mcg/L) will be assayed.
Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 6 months
Type 1 procollagen (P1NP, in mcg/L) will be assayed.
Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 12 months
Type 1 procollagen (P1NP, in mcg/L) will be assayed.
Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 24 months
Type 1 procollagen (P1NP, in mcg/L) will be assayed.
Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline
C-terminal telopeptide (CTX, in pg/mL) will be assayed.
Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 6 months
C-terminal telopeptide (CTX, in pg/mL) will be assayed.
Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 12 months
C-terminal telopeptide (CTX, in pg/mL) will be assayed.
Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 24 months
C-terminal telopeptide (CTX, in pg/mL) will be assayed.
Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline
Calcium (in mg/dL), albumin (in, g/dL) will be assayed.
Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 6 months
Calcium (in mg/dL), albumin (in, g/dL) will be assayed.
Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 12 months
Calcium (in mg/dL), albumin (in, g/dL) will be assayed.
Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 24 months
Calcium (in mg/dL), albumin (in, g/dL) will be assayed.
Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline
Parathyroid hormone (PTH, in pg/mL) will be assayed.
Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 6 months
Parathyroid hormone (PTH, in pg/mL) will be assayed.
Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 12 months
Parathyroid hormone (PTH, in pg/mL) will be assayed.
Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 24 months
Parathyroid hormone (PTH, in pg/mL) will be assayed.
Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline
25-OH vitamin D (in ng/mL) will be assayed.
Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 6 months
25-OH vitamin D (in ng/mL) will be assayed.
Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 12 months
25-OH vitamin D (in ng/mL) will be assayed.
Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time Frame: Baseline to 24 months
25-OH vitamin D (in ng/mL) will be assayed.
Baseline to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Society for Metabolic and Bariatric Surgery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jayleen G Grams, MD,PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300000701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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