Bone Loss After Laparoscopic Roux-en-Y Gastric Bypass

NCT00975013 | Completed

• 1 other identifier: 2-07-02-009
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess changes bone mineral density and bone metabolism after laparoscopic Roux-en-Y gastric bypass surgery. The investigators hypothesize that weight loss after laparoscopic Roux-en-Y gastric bypass surgery will be associated with increased bone turnover, changes in bone metabolism, and loss of bone mass.

Conditions

Bone Loss; Bone Density; Gastric Bypass; Bariatric Surgery

Keywords

Laparoscopic Gastric Bypass; Morbid Obesity; Bone Mineral Density

Outcome Measures

Primary Outcomes (1)

• Evaluate bone densitometry and lab tests to assess changes in bone mass and bone turnover after laparoscopic gastric bypass surgery

  preoperatively and at 6 and 12 months after laparoscopic Roux-en-Y gastric bypass

Secondary Outcomes (1)

• Evaluate weight loss, menopausal and nutritional status to assess correlations with results from bone densitometry and lab values after laparoscopic gastric bypass surgery

  preoperatively, and at 6 and 12 months after laparoscopic Roux-en-Y gastric bypass

Study Arms (1)

Bone Density Study Group

Morbidly obese, (BMI \>40 kg/m2, or 35 kg/m2 with comorbidities) female patients who have given consent to undergo additional testing including bone densitometry, and lab testing preoperatively and at 6 and 12 months after undergoing elective laparoscopic roux-en-Y gastric bypass.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of patients undergoing laparoscopic gastric bypass at a community-based teaching institution

You may qualify if:

• Morbidly obese female patients undergoing elective laparoscopic Roux-en-Y gastric bypass at a single institution

You may not qualify if:

• Male patients
• Patients unable to fulfill the study protocol requirements

Sponsors & Collaborators

• Gundersen Lutheran Medical Foundation: lead
• Gundersen Lutheran Health System: collaborator

Study Sites (1)

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (9)

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  PMID: 10546691 BACKGROUND

• Morberg CM, Tetens I, Black E, Toubro S, Soerensen TI, Pedersen O, Astrup A. Leptin and bone mineral density: a cross-sectional study in obese and nonobese men. J Clin Endocrinol Metab. 2003 Dec;88(12):5795-800. doi: 10.1210/jc.2003-030496.

  PMID: 14671171 BACKGROUND

• Cundy T, Evans MC, Kay RG, Dowman M, Wattie D, Reid IR. Effects of vertical-banded gastroplasty on bone and mineral metabolism in obese patients. Br J Surg. 1996 Oct;83(10):1468-72. doi: 10.1002/bjs.1800831046.

  PMID: 8944476 BACKGROUND

• von Mach MA, Stoeckli R, Bilz S, Kraenzlin M, Langer I, Keller U. Changes in bone mineral content after surgical treatment of morbid obesity. Metabolism. 2004 Jul;53(7):918-21. doi: 10.1016/j.metabol.2004.01.015.

  PMID: 15254887 BACKGROUND

• Meyer HE, Tverdal A, Selmer R. Weight variability, weight change and the incidence of hip fracture: a prospective study of 39,000 middle-aged Norwegians. Osteoporos Int. 1998;8(4):373-8. doi: 10.1007/s001980050077.

  PMID: 10024908 BACKGROUND

• Bano G, Rodin DA, Pazianas M, Nussey SS. Reduced bone mineral density after surgical treatment for obesity. Int J Obes Relat Metab Disord. 1999 Apr;23(4):361-5. doi: 10.1038/sj.ijo.0800827.

  PMID: 10340813 BACKGROUND

• Coates PS, Fernstrom JD, Fernstrom MH, Schauer PR, Greenspan SL. Gastric bypass surgery for morbid obesity leads to an increase in bone turnover and a decrease in bone mass. J Clin Endocrinol Metab. 2004 Mar;89(3):1061-5. doi: 10.1210/jc.2003-031756.

  PMID: 15001587 BACKGROUND

• Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7.

  PMID: 14742841 BACKGROUND

• Carlin AM, Rao DS, Yager KM, Parikh NJ, Kapke A. Treatment of vitamin D depletion after Roux-en-Y gastric bypass: a randomized prospective clinical trial. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):444-9. doi: 10.1016/j.soard.2008.08.004. Epub 2008 Aug 14.

  PMID: 18996761 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Bone Diseases, Metabolic; Obesity, Morbid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shanu N Kothari, M.D.

  Gundersen Lutheran Health System

  PRINCIPAL INVESTIGATOR

• Kevin P Riess, M.D.

  Gundersen Lutheran Medical Foundation; Current Practice: SMDC Health System-Duluth Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Researcher

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: April 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

US (1)