Effects of Weight Loss Surgery on Bone Health in Adolescents

September 22, 2025 updated by: Madhusmita Misra, Massachusetts General Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

240

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

Ages Eligible for Study

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adolescents and young adults 13-25 years old with obesity undergoing RYGB or VSG and non-surgical controls.

Description

Inclusion Criteria:

  1. Adolescents with morbid obesity 13-25yo undergoing RYGB (n=36) or VSG (n=36), or being followed without surgical intervention (usual care) (n=48).
  2. 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.

Exclusion Criteria:

  1. Current pregnancy and breast feeding
  2. 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)
  3. Use of antipsychotic medications that cause weight gain if treated for <6 mos, or if dosage is not stable for >2 mos
  4. Untreated thyroid dysfunction or on stable dose for <3 mos
  5. HbA1C>8% (to avoid deleterious effects on bone from uncontrolled T2DM)
  6. Smoking >10 cigarettes/day; substance abuse per Diagnostic and Statistical Manual (DSM) V
  7. Metal implants, intracranial surgical clips or pacemakers
  8. Weight >450 lbs due to limits for MRI and CT.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Roux-en-Y Gastric Bypass
Males and females aged 13-25 undergoing Roux-en-Y gastric bypass (RYGB) surgery
Procedure: Roux-en-Y Gastric Bypass
Determination of the kind of surgery will be made by the participant's providers and not by study staff
Other Names:
  • RYGB
Vertical Sleeve Gastrectomy
Males and females aged 13-25 undergoing vertical sleeve gastrectomy (VSG) surgery
Procedure: Vertical Sleeve Gastrectomy
Determination of the kind of surgery will be made by the participant's providers and not by study staff
Other Names:
  • VSG
Non-surgical Obese Controls
Males and females aged 13-25 who are obese and not undergoing weight loss surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline to 24 months change in total and trabecular volumetric BMD (vBMD) (distal radius and tibia)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Baseline to 24 month change in bone turnover markers (P1NP and CTX)
Time Frame: 2 years
2 years
Baseline to 24 month change in estimated strength measures (FEA of distal radius and tibia)
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Madhu Misra, MD, MPH, Massachusetts General Hospital
  • Principal Investigator: Miriam Bredella, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2015

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimated)

September 23, 2015

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P000360

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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