Bariatric Surgery and Skeletal Health

NCT ID: NCT01098942

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2018-03-31

Brief Summary

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Bone loss may occur after bariatric (weight loss) surgery, but standard methods of measuring bone density in obese patients are potentially inaccurate. This study uses quantitative computed tomography to examine changes in bone mineral density after bariatric surgery. We are also studying mechanisms which may explain bone loss after bariatric surgery.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical

Roux-en-Y gastric bypass surgery

No interventions assigned to this group

Non-surgical

Non-surgical lifestyle weight management

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program

Exclusion Criteria

* Weight ≥ than 450 lbs
* Postmenopausal women
* Significant heart, kidney, liver, or malignant disease
* Current disorders known to affect bone
* Use of medications known to affect bone for more than 7 days in the past 12 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elaine W. Yu

Co-investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel S. Finkelstein, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

MGH

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Yu EW, Bouxsein ML, Putman MS, Monis EL, Roy AE, Pratt JS, Butsch WS, Finkelstein JS. Two-year changes in bone density after Roux-en-Y gastric bypass surgery. J Clin Endocrinol Metab. 2015 Apr;100(4):1452-9. doi: 10.1210/jc.2014-4341. Epub 2015 Feb 3.

Reference Type DERIVED
PMID: 25646793 (View on PubMed)

Yu EW, Bouxsein ML, Roy AE, Baldwin C, Cange A, Neer RM, Kaplan LM, Finkelstein JS. Bone loss after bariatric surgery: discordant results between DXA and QCT bone density. J Bone Miner Res. 2014 Mar;29(3):542-50. doi: 10.1002/jbmr.2063.

Reference Type DERIVED
PMID: 23929784 (View on PubMed)

Other Identifiers

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2009P001445

Identifier Type: -

Identifier Source: org_study_id

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