Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS) (BABS)
Phase 2 Study of Patients Undergoing Bariatric Surgery (Laparoscopic Gastric Bypass) and Evaluation of Bone Metabolism With/Without Vitamin D/Calcium Supplementation
Bariatric surgery leads to rapid weight loss in female and male patients. Less data are available about its impact on bone metabolism.
The aim of this study is the investigation of changes in bone mineral density,bone histomorphometric changes, serum bone turnover markers and changes in body fat and muscle composition in patients after laparoscopic gastric bypass surgery.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Obese female and male adult patients eligible for laparoscopic gastric bypass surgery according to the national Austrian guidelines will be included in this study upon request and after patient approval.
Baseline data collection and quarterly follow up visits are planned to investigate the changes in bone mineral density and body composition measured by dual energy X-ray absorptiometry as well as the evaluation of serum bone turnover markers of bone formation and resorption.
After surgery subjects will be randomized into two groups:
Daily oral calcium (500mg) and weekly vitamin D3 supplementation (16.000 IU calciferol)or no supplementation of calcium and calciferol.
A sub-study (approximately 15% of study population) with transiliac bone biopsies will also be performed to investigate histomorphometric and histologic changes in bone (biopsy baseline and after 24 months).
The planned duration of the study is 24 months for each subject. Serum bone turnover markers will be collected every 3 months, dual energy X-ray absorptiometry measurements will be performed every 6 months.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
-
Vienna, Österrike, 1060
- Medical University Vienna
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- body mass index >35
- female and male patients
- age 18 - 65 years
- eligible for laparoscopic gastric bypass surgery according to the Austrian national guidelines
Exclusion Criteria:
- any history of malignancy except basalioma
- any prior antiresorptive treatment
- any prior calcium or vitamin D supplementation
- any secondary disease affecting bone metabolism
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Calcium/Vitamin D
All subjects will receive calcium/vitamin D supplementation after laparoscopic bariatric gastric bypass surgery as follows: daily: 500 mg oral calcium (calcium carbonate) weekly: 16.000 IU oral vitamin D3 (calciferol) |
|
|
Inget ingripande: No Calcium/Vitamin D
All subjects will not receive calcium/vitamin D supplementation after laparoscopic bariatric gastric bypass surgery.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery
Tidsram: Evaluation every 6 months for 24 months
|
Dual energy X-ray absorptiometry (DXA) measurements of bone mineral density at lumbar spine, hip, calcaneus and total body will be performed at baseline and every six months for a period of 24 months. Differences will be evaluated on the outcome with/without daily calcium (500mg) and weekly vitamin D (16.000 IU calciferol) supplementation |
Evaluation every 6 months for 24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of changes of serum bone turnover markers in obese patients after laparoscopic bariatric surgery
Tidsram: Evaluation every 3 months for 24 months
|
Fasting serum markers of bone formation and bone resorption will be evaluated: Calcium, 25-OH-vitamin D3, intact parathyroid hormone, beta-crosslaps, type-1-procollagen, bone specific alkaline phosphatase, osteocalcin, sclerostin, osteoprotegerin, cathepsin-K, fibroblast factor 23, lipoprotein A, dickkopf 1 Differences will be evaluated on the outcome with/without daily calcium (500mg) and weekly vitamin D (16.000 IU calciferol) supplementation |
Evaluation every 3 months for 24 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of histomorphometric and histologic changes in obese patients after laparoscopic bariatric surgery
Tidsram: baseline and after 24 months
|
Transiliac bone biopsies will be performed in a approximately 15% of patients at baseline and after 24 months. The following parameters will be measured: bone volume (BV/TV), bone surface (BS/BV), osteoblast surface (OS/BS), trabecular number (TbN), trabecular thickness (TbTh, trabecular separation (Tb.sp), mineralized surface (MS/BS), mineral apposition rate (MAR) Differences will be evaluated on the outcome with/without daily calcium (500mg) and weekly vitamin D (16.000 IU colecalciferol) supplementation |
baseline and after 24 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christian Muschitz, M.D., Medical University Vienna - Austria
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Metaboliska sjukdomar
- Muskuloskeletala sjukdomar
- Skelettsjukdomar
- Skelettsjukdomar, metaboliska
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Gastrointestinala medel
- Mikronäringsämnen
- Vitaminer
- Bendensitetsbevarande medel
- Kalciumreglerande hormoner och medel
- Antacida
- Kalcium
- Ergocalciferoler
- Kalciumkarbonat
Andra studie-ID-nummer
- Vinforce-015
- Vinforce 015 (Annan identifierare: Medical University Vienna)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .