OsteopeniaPhase 3NCT04377230
BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass
A Phase 3 study testing biliopancreatic limb length of 60cm. and biliopancreatic limb length of 100cm. in people with Osteopenia, run by Hospital General Universitario Elche.
Trial summary
Patients will be randomized into 2 groups: Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Bone mineral density will be evaluated before surgery and 2 years… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteopenia
- What is being tested?
- biliopancreatic limb length of 60cm. and biliopancreatic limb length of 100cm.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2020to 1 May 2022
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index >40 Kg/m2
- Body mass index >35 Kg/m2 associated to obesity related comorbidities
Who cannot join
- Bone pathologies
- Active neoplasms
- Disorders in calcium or vitamin D metabolism
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery
Patients will be randomized into 2 groups:
- Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
- Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm
Bone mineral density will be evaluated before surgery and 2 years after it.
Read the detailed description
Patients will be randomized into 2 groups:
- Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
- Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)
Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.
- Conditions
- Osteopenia
- Being tested
- biliopancreatic limb length of 60cm., biliopancreatic limb length of 100cm.
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliopancreatic limb length of 60cm.Procedure or surgery
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
biliopancreatic limb length of 100cm.Procedure or surgery
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
| Study group | Role | What they receive |
|---|---|---|
| Biliopancreatic limb 60cm | Experimental | Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm. Receives: Procedure: biliopancreatic limb length of 60cm. |
| Biliopancreatic limb 100cm | Active comparator | Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm. Receives: Procedure: biliopancreatic limb length of 100cm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start7 May 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Seguridad Social del Estado de Mexico y Municipios
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Jaime Ruiz-Tovar, Principal investigator, Garcilaso Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377230
- Sponsor's protocol ID
- Garcilaso-Mex 20-3
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery
- ClinicalTrials.gov ID
- NCT04377230
- Acronym / sponsor ID
- Garcilaso-Mex 20-3
- Conditions
- Osteopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Collaborators
- Instituto de Seguridad Social del Estado de Mexico y Municipios
- Study start
- 7 May 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 6 May 2020 (actual)
- 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.
Patients will be randomized into 2 groups:
- Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
- Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm
Bone mineral density will be evaluated before surgery and 2 years after it.
Detailed description
Patients will be randomized into 2 groups:
- Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
- Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)
Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biliopancreatic limb 60cm | Experimental | Procedure: biliopancreatic limb length of 60cm.Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm. |
| Biliopancreatic limb 100cm | Active comparator | Procedure: biliopancreatic limb length of 100cm.Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index >40 Kg/m2
- Body mass index >35 Kg/m2 associated to obesity related comorbidities
Key exclusion criteria (3 listed)
- Bone pathologies
- Active neoplasms
- Disorders in calcium or vitamin D metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biliopancreatic limb length of 60cm.Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm. | Procedure or surgery | Biliopancreatic limb 60cm |
| biliopancreatic limb length of 100cm.Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm. | Procedure or surgery | Biliopancreatic limb 100cm |
Primary outcome
Bone mineral density
Time frame: 2 years after surgery
Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
Related trials for Osteopenia
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
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.
Jaime Ruiz-Tovar principal investigator
Garcilaso Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biliopancreatic limb length of 60cm. and biliopancreatic limb length of 100cm. in people with Osteopenia, run by Hospital General Universitario Elche.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina LLavero Garrido (649593020, carolinallavero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.