Morbid ObesityNCT01098942
Bariatric Surgery and Skeletal Health
An observational study of Morbid Obesity, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese adults
Who may be able to join
- Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
MGH
Boston, Massachusetts
About this study
Official title: Effects of Bariatric Surgery on Skeletal Health
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.
- Conditions
- Morbid Obesity
- Keywords
- bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Roux-en-Y gastric bypass surgery | |
| Non-surgical | Non-surgical lifestyle weight management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)
Measured: 1 year
Secondary outcomes (2)
Changes in serum and/or urine indices of bone formation and bone resorption, such as aminoterminal propeptide of type I collagen [PINP], osteocalcin, C-telopeptide cross-links [CTX])
Measured: 1 year
Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2012
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine W. Yu, Massachusetts General Hospital
- Investigators
- Joel S. Finkelstein, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098942
- Sponsor's protocol ID
- 2009P001445
- Status last verified
- Mar 2018
- First submitted
- 2 Apr 2010
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25646793Yu 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.
PubMed 23929784
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on Skeletal Health
- ClinicalTrials.gov ID
- NCT01098942
- Acronym / sponsor ID
- 2009P001445
- Conditions
- Morbid Obesity
- Keywords
- bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Apr 2010 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | –Roux-en-Y gastric bypass surgery |
| Non-surgical | – | –Non-surgical lifestyle weight management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese adults
Key inclusion criteria (1 listed)
- Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)
Time frame: 1 year
2 secondary outcomes
Changes in serum and/or urine indices of bone formation and bone resorption, such as aminoterminal propeptide of type I collagen [PINP], osteocalcin, C-telopeptide cross-links [CTX])
Time frame: 1 year
Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Derived from this study: PubMed 25646793Yu 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.
- Derived from this study: PubMed 23929784Yu 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.
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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.
Joel S. Finkelstein, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Massachusetts General Hospital at 2 sites 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT) (time frame: 1 year). 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 NCT01098942, which also lists 2 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 21 Mar 2018.