NCT02557438Active, not recruiting
Effects of Weight Loss Surgery on Bone Health in Adolescents
Bone Metabolism in Adolescents Undergoing Bariatric Surgery
Source: ClinicalTrials.gov · Last updated 25 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 21 Sept 2015
- Start date
- 1 Jun 2015
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity
- NCT number
- NCT02557438
What you commit to
- Study type: Observational
- Planned participants: 240
- From 1 Jun 2015 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antipsychotic medications that cause weight gain if treated for \<6 mos, or if dosage is not stable for \>2 mos
- Metal implants, intracranial surgical clips or pacemakers
Lab values
- 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)
- HbA1C\>8% (to avoid deleterious effects on bone from uncontrolled T2DM)
Other
- Current pregnancy and breast feeding
- Untreated thyroid dysfunction or on stable dose for \<3 mos
- Smoking \>10 cigarettes/day; substance abuse per Diagnostic and Statistical Manual (DSM) V
- Weight \>450 lbs due to limits for MRI and CT.
Who the study is looking for
- 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.
Age in the registry: 13 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.