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NCT03046147 Clinical Trial

The Effect of Roux-en-Y Gastric Bypass on Bone Turnover

Obesity Clinical Trial

Official title:
Bone Mineral Density and Markers of Bone Turnover After Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03046147
Other study ID # KBM-IS-Bone
Secondary ID
Status Recruiting
Phase N/A
First received February 6, 2017
Last updated February 6, 2017
Start date September 2015
Est. completion date September 2017

Study information
Verified date February 2017
Source Hvidovre University Hospital
Contact Kirstine N Bojsen-Møller, MD, PhD
Phone 4538626371
Email kirstine.bojsen-moeller@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing (forearm) regions before and after maximal weight loss at 1 year and after weight stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be studied at fasting and during oral glucose tolerance test.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date September 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Participation in previos study ((NCT 01202526)

Exclusion Criteria:

- Treatment of osteoporosis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery for morbid obesity

Locations
Country Name City State
Denmark Copenhagen University hospital Hvidovre Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone mineral density of non-weight bearing bone DXA scans of forearm 1 year, 4 years
Primary Changes in bone mineral density of weightbearing bone DXA scans of hip and lumbal columna 1 year, 4 years
Secondary Plasma markers of bone turnover At fasting 1 week, 3 months, 1 year, 4 years
Secondary Plasma markers of bone turnover during OGTT 3 months, 1 year, 4 years
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