ObesityNCT02557438
Effects of Weight Loss Surgery on Bone Health in Adolescents
An observational study of Obesity and Surgery, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of weight-loss surgery (Roux-en-Y gastric bypass or Vertical Sleeve Gastrectomy) on bone outcomes in girls and boys ages 13-21. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- What is being tested?
- Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents and young adults 13-25 years old with obesity undergoing RYGB or VSG and non-surgical controls.
Who may be able to join
- Adolescents with morbid obesity 13-25yo undergoing RYGB (n=36) or VSG (n=36), or being followed without surgical intervention (usual care) (n=48).
- Eligibility criteria for weight loss surgery used at the Weight Center include BMI>40 or BMI>35kg/m2 with major comorbidities. A BMI>35 in adolescents reflects a BMI>99th percentile. In order to be considered appropriate surgical candidates, children must have a bone age of ≥14y (F) or ≥16y (M), and ≥1 co-morbidity of obesity. They must have demonstrated efforts at non-surgical weight loss, and consistent compliance with appointments and recommendations. Patients must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of the procedure and implement required post-operative behavioral changes.
Who cannot join
- Current pregnancy and breast feeding
- Medications other than calcium or vitamin D that affect bone, such as glucocorticoids, phenytoin, phenobarbitone (washout of 3 months prior to enrollment if discontinuation is medically permissible)
- Use of antipsychotic medications that cause weight gain if treated for <6 mos, or if dosage is not stable for >2 mos
- Untreated thyroid dysfunction or on stable dose for <3 mos
- HbA1C>8% (to avoid deleterious effects on bone from uncontrolled T2DM)
- Smoking >10 cigarettes/day; substance abuse per Diagnostic and Statistical Manual (DSM) V
- Metal implants, intracranial surgical clips or pacemakers
- Weight >450 lbs due to limits for MRI and CT.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Bone Metabolism in Adolescents Undergoing Bariatric Surgery
The purpose of this study is to examine the impact of weight-loss surgery (Roux-en-Y gastric bypass or Vertical Sleeve Gastrectomy) on bone outcomes in girls and boys ages 13-21. This study will also examine a group of overweight boys and girls who are not scheduled or planned for surgery for comparison of these outcomes.
Obese adults who undergo weight-loss surgery are at risk for bone loss and decreased bone strength. The investigators do not know the effects of such surgery on bone in teenagers and young adults. The purpose of this study is to find out how different types of weight loss surgery affect bone density and strength in teenagers and young adults and compare these results to obese teenagers and young adults who are not undergoing weight-loss surgery.
Read the detailed description
Our overall hypothesis is that both Roux-en-Y Gastric Bypass (RYGB) and vertical sleeve gastrectomy (VSG) in adolescents with morbid obesity will lead to a reduction in areal and volumetric BMD, and deterioration in bone structure and estimated bone strength, and an increase in marrow adiposity. We further hypothesize that these effects will be due in part to a decrease in lean mass, changes in enteric peptide hormones and reduced estrogen levels.
We will enroll 120 participants 13-21 years old for this two-year longitudinal study (36 in each of the surgical groups and 48 non-surgical controls with obesity). We will screen up to 240 subjects to find these 120 eligibile subjects. Areal bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry (DXA), volumetric BMD by quantitative computed tomography (QCT), bone structure and strength using high resolution peripheral QCT and finite element analysis, and marrow fat using magnetic resonance spectroscopy. Body composition will also be assessed.
Adolescence is a critical time for bone accrual and the use of bariatric procedures is increasing in teenagers. This study will provide novel data needed to establish effects of RYGB vs. VSG on bone in adolescents and will begin to delineate underlying mechanisms. Clarifying these mechanisms will identify therapeutic targets to optimize bone accrual in adolescents undergoing bariatric surgery.
- Being tested
- Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy
- Keywords
- Bone, Child Health, Nutrition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y Gastric BypassProcedure or surgery
Also called RYGB
Determination of the kind of surgery will be made by the participant's providers and not by study staff
Vertical Sleeve GastrectomyProcedure or surgery
Also called VSG
Determination of the kind of surgery will be made by the participant's providers and not by study staff
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y Gastric Bypass | Males and females aged 13-25 undergoing Roux-en-Y gastric bypass (RYGB) surgery Receives: Procedure: Roux-en-Y Gastric Bypass | |
| Vertical Sleeve Gastrectomy | Males and females aged 13-25 undergoing vertical sleeve gastrectomy (VSG) surgery Receives: Procedure: Vertical Sleeve Gastrectomy | |
| Non-surgical Obese Controls | Males and females aged 13-25 who are obese and not undergoing weight loss surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline to 24 months change in total and trabecular volumetric BMD (vBMD) (distal radius and tibia)
Measured: 2 years
Secondary outcomes (2)
Baseline to 24 month change in bone turnover markers (P1NP and CTX)
Measured: 2 years
Baseline to 24 month change in estimated strength measures (FEA of distal radius and tibia)
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 posted23 Sep 2015 (estimated)
- Study start1 Jun 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhusmita Misra, Massachusetts General Hospital
- Investigators
- Madhu Misra, MD, MPH, Principal investigator, Massachusetts General HospitalMiriam Bredella, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557438
- Sponsor's protocol ID
- 2015P000360
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2015
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tuli S, Lopez Lopez AP, Nimmala S, Pedreira CC, Singhal V, Bredella MA, Misra M. Two-Year Study on the Impact of Sleeve Gastrectomy on Depressive and Anxiety Symptoms in Adolescents and Young Adults with Moderate to Severe Obesity. Obes Surg. 2024 Feb;34(2):568-575. doi: 10.1007/s11695-023-07025-z. Epub 2024 Jan 4.
PubMed 38177554Mitchell DM, Singhal V, Nimmala S, Lauze M, Bouxsein ML, Misra M, Bredella MA. Risk of wrist fracture, estimated by the load-to-strength ratio, declines following sleeve gastrectomy in adolescents and young adults. Osteoporos Int. 2024 Feb;35(2):285-291. doi: 10.1007/s00198-023-06941-1. Epub 2023 Oct 21.
PubMed 37864596Kaur S, Nimmala S, Singhal V, Mitchell DM, Pedreira CC, Lauze M, Lee H, Stanford FC, Bouxsein ML, Bredella MA, Misra M. Bone changes post-sleeve gastrectomy in relation to body mass and hormonal changes. Eur J Endocrinol. 2023 Sep 1;189(3):346-354. doi: 10.1093/ejendo/lvad121.
PubMed 37633255Kaur S, Bredella MA, Misra M, Singhal V. Trajectory of Gonadal Hormones in Adolescent Males up to 2 Years After Sleeve Gastrectomy. Obes Surg. 2023 Oct;33(10):3323-3326. doi: 10.1007/s11695-023-06759-0. Epub 2023 Aug 10.
PubMed 37561269Lopez Lopez AP, Tuli S, Lauze M, Becetti I, Pedreira CC, Huber FA, Omeroglu E, Singhal V, Misra M, Bredella MA. Changes in Hepatic Fat Content by CT 1 Year After Sleeve Gastrectomy in Adolescents and Young Adults With Obesity. J Clin Endocrinol Metab. 2023 Nov 17;108(12):e1489-e1495. doi: 10.1210/clinem/dgad390.
PubMed 37403207Huber FA, Singhal V, Tuli S, Becetti I, Lopez Lopez AP, Bouxsein ML, Misra M, Bredella MA. Two-year Skeletal Effects of Sleeve Gastrectomy in Adolescents with Obesity Assessed with Quantitative CT and MR Spectroscopy. Radiology. 2023 Jun;307(5):e223256. doi: 10.1148/radiol.223256.
PubMed 37310246Mitchell DM, Singhal V, Animashaun A, Bose A, Carmine B, Stanford FC, Inge TH, Kelsey MM, Lee H, Bouxsein ML, Yu EW, Bredella MA, Misra M. Skeletal Effects of Sleeve Gastrectomy in Adolescents and Young Adults: A 2-Year Longitudinal Study. J Clin Endocrinol Metab. 2023 Mar 10;108(4):847-857. doi: 10.1210/clinem/dgac634.
PubMed 36314507Nimmala S, Kaur S, Singhal V, Mitchell DM, Stanford FC, Bouxsein ML, Lauze M, Huynh C, Pedreira CC, Lee H, Bredella MA, Misra M. Changes in Sex Steroids and Enteric Peptides After Sleeve Gastrectomy in Youth in Relation to Changes in Bone Parameters. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3747-e3758. doi: 10.1210/clinem/dgac361.
PubMed 35689793
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Metabolism in Adolescents Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02557438
- Acronym / sponsor ID
- 2015P000360
- Keywords
- Bone, Child Health, Nutrition
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the impact of weight-loss surgery (Roux-en-Y gastric bypass or Vertical Sleeve Gastrectomy) on bone outcomes in girls and boys ages 13-21. This study will also examine a group of overweight boys and girls who are not scheduled or planned for surgery for comparison of these outcomes.
Obese adults who undergo weight-loss surgery are at risk for bone loss and decreased bone strength. The investigators do not know the effects of such surgery on bone in teenagers and young adults. The purpose of this study is to find out how different types of weight loss surgery affect bone density and strength in teenagers and young adults and compare these results to obese teenagers and young adults who are not undergoing weight-loss surgery.
Detailed description
Our overall hypothesis is that both Roux-en-Y Gastric Bypass (RYGB) and vertical sleeve gastrectomy (VSG) in adolescents with morbid obesity will lead to a reduction in areal and volumetric BMD, and deterioration in bone structure and estimated bone strength, and an increase in marrow adiposity. We further hypothesize that these effects will be due in part to a decrease in lean mass, changes in enteric peptide hormones and reduced estrogen levels.
We will enroll 120 participants 13-21 years old for this two-year longitudinal study (36 in each of the surgical groups and 48 non-surgical controls with obesity). We will screen up to 240 subjects to find these 120 eligibile subjects. Areal bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry (DXA), volumetric BMD by quantitative computed tomography (QCT), bone structure and strength using high resolution peripheral QCT and finite element analysis, and marrow fat using magnetic resonance spectroscopy. Body composition will also be assessed.
Adolescence is a critical time for bone accrual and the use of bariatric procedures is increasing in teenagers. This study will provide novel data needed to establish effects of RYGB vs. VSG on bone in adolescents and will begin to delineate underlying mechanisms. Clarifying these mechanisms will identify therapeutic targets to optimize bone accrual in adolescents undergoing bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y Gastric Bypass | – | Procedure: Roux-en-Y Gastric BypassMales and females aged 13-25 undergoing Roux-en-Y gastric bypass (RYGB) surgery |
| Vertical Sleeve Gastrectomy | – | Procedure: Vertical Sleeve GastrectomyMales and females aged 13-25 undergoing vertical sleeve gastrectomy (VSG) surgery |
| Non-surgical Obese Controls | – | –Males and females aged 13-25 who are obese and not undergoing weight loss surgery |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and young adults 13-25 years old with obesity undergoing RYGB or VSG and non-surgical controls.
Key inclusion criteria (2 listed)
- Adolescents with morbid obesity 13-25yo undergoing RYGB (n=36) or VSG (n=36), or being followed without surgical intervention (usual care) (n=48).
- Eligibility criteria for weight loss surgery used at the Weight Center include BMI>40 or BMI>35kg/m2 with major comorbidities. A BMI>35 in adolescents reflects a BMI>99th percentile. In order to be considered appropriate surgical candidates, children must have a bone age of ≥14y (F) or ≥16y (M), and ≥1 co-morbidity of obesity. They must have demonstrated efforts at non-surgical weight loss, and consistent compliance with appointments and recommendations. Patients must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of the procedure and implement required post-operative behavioral changes.
Key exclusion criteria (8 listed)
- Current pregnancy and breast feeding
- Medications other than calcium or vitamin D that affect bone, such as glucocorticoids, phenytoin, phenobarbitone (washout of 3 months prior to enrollment if discontinuation is medically permissible)
- Use of antipsychotic medications that cause weight gain if treated for <6 mos, or if dosage is not stable for >2 mos
- Untreated thyroid dysfunction or on stable dose for <3 mos
- HbA1C>8% (to avoid deleterious effects on bone from uncontrolled T2DM)
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 |
|---|---|---|
| Roux-en-Y Gastric BypassAlso: RYGBDetermination of the kind of surgery will be made by the participant's providers and not by study staff | Procedure or surgery | Roux-en-Y Gastric Bypass |
| Vertical Sleeve GastrectomyAlso: VSGDetermination of the kind of surgery will be made by the participant's providers and not by study staff | Procedure or surgery | Vertical Sleeve Gastrectomy |
Primary outcome
Baseline to 24 months change in total and trabecular volumetric BMD (vBMD) (distal radius and tibia)
Time frame: 2 years
2 secondary outcomes
Baseline to 24 month change in bone turnover markers (P1NP and CTX)
Time frame: 2 years
Baseline to 24 month change in estimated strength measures (FEA of distal radius and tibia)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Derived from this study: PubMed 38177554Tuli S, Lopez Lopez AP, Nimmala S, Pedreira CC, Singhal V, Bredella MA, Misra M. Two-Year Study on the Impact of Sleeve Gastrectomy on Depressive and Anxiety Symptoms in Adolescents and Young Adults with Moderate to Severe Obesity. Obes Surg. 2024 Feb;34(2):568-575. doi: 10.1007/s11695-023-07025-z. Epub 2024 Jan 4.
- Derived from this study: PubMed 37864596Mitchell DM, Singhal V, Nimmala S, Lauze M, Bouxsein ML, Misra M, Bredella MA. Risk of wrist fracture, estimated by the load-to-strength ratio, declines following sleeve gastrectomy in adolescents and young adults. Osteoporos Int. 2024 Feb;35(2):285-291. doi: 10.1007/s00198-023-06941-1. Epub 2023 Oct 21.
- Derived from this study: PubMed 37633255Kaur S, Nimmala S, Singhal V, Mitchell DM, Pedreira CC, Lauze M, Lee H, Stanford FC, Bouxsein ML, Bredella MA, Misra M. Bone changes post-sleeve gastrectomy in relation to body mass and hormonal changes. Eur J Endocrinol. 2023 Sep 1;189(3):346-354. doi: 10.1093/ejendo/lvad121.
- Derived from this study: PubMed 37561269Kaur S, Bredella MA, Misra M, Singhal V. Trajectory of Gonadal Hormones in Adolescent Males up to 2 Years After Sleeve Gastrectomy. Obes Surg. 2023 Oct;33(10):3323-3326. doi: 10.1007/s11695-023-06759-0. Epub 2023 Aug 10.
- Derived from this study: PubMed 37403207Lopez Lopez AP, Tuli S, Lauze M, Becetti I, Pedreira CC, Huber FA, Omeroglu E, Singhal V, Misra M, Bredella MA. Changes in Hepatic Fat Content by CT 1 Year After Sleeve Gastrectomy in Adolescents and Young Adults With Obesity. J Clin Endocrinol Metab. 2023 Nov 17;108(12):e1489-e1495. doi: 10.1210/clinem/dgad390.
- Derived from this study: PubMed 37310246Huber FA, Singhal V, Tuli S, Becetti I, Lopez Lopez AP, Bouxsein ML, Misra M, Bredella MA. Two-year Skeletal Effects of Sleeve Gastrectomy in Adolescents with Obesity Assessed with Quantitative CT and MR Spectroscopy. Radiology. 2023 Jun;307(5):e223256. doi: 10.1148/radiol.223256.
- Derived from this study: PubMed 36314507Mitchell DM, Singhal V, Animashaun A, Bose A, Carmine B, Stanford FC, Inge TH, Kelsey MM, Lee H, Bouxsein ML, Yu EW, Bredella MA, Misra M. Skeletal Effects of Sleeve Gastrectomy in Adolescents and Young Adults: A 2-Year Longitudinal Study. J Clin Endocrinol Metab. 2023 Mar 10;108(4):847-857. doi: 10.1210/clinem/dgac634.
- Derived from this study: PubMed 35689793Nimmala S, Kaur S, Singhal V, Mitchell DM, Stanford FC, Bouxsein ML, Lauze M, Huynh C, Pedreira CC, Lee H, Bredella MA, Misra M. Changes in Sex Steroids and Enteric Peptides After Sleeve Gastrectomy in Youth in Relation to Changes in Bone Parameters. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3747-e3758. doi: 10.1210/clinem/dgac361.
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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.
Madhu Misra, MD, MPH principal investigator
Massachusetts General Hospital
Miriam Bredella, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Surgery, run by Massachusetts General Hospital 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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Baseline to 24 months change in total and trabecular volumetric BMD (vBMD) (distal radius and tibia) (time frame: 2 years). 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 NCT02557438, which also lists 8 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 25 Sep 2025.