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Status unknownNCT03046147Updated Feb 8, 2017

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

An observational study in Gastric Bypass Surgery, Obesity and Bone Loss, sponsored by Hvidovre University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-08.

Sponsored by Hvidovre University Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 70 Years
Sex
All
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Study 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.

02

Conditions studied

  • Gastric Bypass Surgery
  • Obesity
  • Bone Loss
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In context

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be recruited from a previously investigated cohort of 20 subjects undergoing Roux-en-Y gastric bypass surgery (NCT 01202526). The previous study aimed at investigating acute and long term changes in insulin sensitivity and secretion, whereas the present follow-up study investigates changes in bone metabolism as the primary outcome.

Inclusion criteria

  • Participation in previos study ((NCT 01202526)

Exclusion criteria

Exclusion Criteria:

  • Treatment of osteoporosis
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • RYGB patients with preoperative type diabetes

    Recruited from a previously investigated cohort (NCT 01202526)

    Procedure: Roux-en-Y gastric bypass

  • RYGB patients with preoperative normal glucose tolerance

    Recruited from a previously investigated cohort (NCT 01202526)

    Procedure: Roux-en-Y gastric bypass

Interventions

  • ProcedureRoux-en-Y gastric bypass

    Roux-en-Y gastric bypass surgery for morbid obesity

06

What researchers measure

Primary outcomes

  1. Changes in bone mineral density of non-weight bearing bone

    DXA scans of forearm

    Time frame: 1 year, 4 years

  2. Changes in bone mineral density of weightbearing bone

    DXA scans of hip and lumbal columna

    Time frame: 1 year, 4 years

Secondary outcomes

  1. Plasma markers of bone turnover

    At fasting

    Time frame: 1 week, 3 months, 1 year, 4 years

  2. Plasma markers of bone turnover

    during OGTT

    Time frame: 3 months, 1 year, 4 years

07

Study locations

1 of 1 sites recruiting
  • Copenhagen University hospital Hvidovre
    Copenhagen, 2820, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03046147
Lead sponsor
Hvidovre University Hospital
Responsible party
Kirstine Nyvold Bojsen-Moeller (MD, PhD, Hvidovre University Hospital) — Principal investigator
First posted
Feb 8, 2017
Start date
Sep 2015
Primary completion
May 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Feb 8, 2017

Study contacts

Kirstine N Bojsen-Møller, MD, PhD
Contact
kirstine.bojsen-moeller@regionh.dk
4538626371

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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