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Skeletal Health in Bariatric Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331536
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
American Society for Metabolic and Bariatric Surgery
Information provided by (Responsible Party):
Jayleen M. Grams, University of Alabama at Birmingham

Brief Summary:
The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

Condition or disease Intervention/treatment
Bariatric Surgery Osteoporosis Fractures, Bone Roux En-Y Gastric Bypass Sleeve Gastrectomy Menopause Premenopause Procedure: Roux en Y Gastric Bypass Pre-menopausal Procedure: Roux en Y Gastric Bypass Post-menopausal Procedure: Sleeve Gastrectomy Pre-menopausal Procedure: Sleeve Gastrectomy Post-menopausal

Detailed Description:
While highly effective both RYGB and SG may lead to increased bone resorption, decreased bone mass, and increased risk of some fractures. Very few studies have compared the effects of the RYGB and the SG on changes skeletal health and findings have been inconsistent. Furthermore, few studies have investigated the short- or long-term consequences of bariatric surgery on bone mineral density in pre- and post-menopausal women. To what extent and how bariatric surgery impacts the skeleton largely remains undetermined. Because estrogen is protective against osteoporosis and fractures, the majority of fractures occur in postmenopausal women. It is important that women have higher rates of obesity (38.3%) compared to men (34.3%) and that ≥67% of bariatric patients are women. Therefore, women may be at a significantly increased risk of developing osteoporosis. These data may help establish clinical guidelines to assess, maintain, and promote skeletal health in the preoperative and postoperative care of bariatric patients; and it may help to determine the appropriate bariatric procedure for women at risk of osteoporosis and fractures.

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skeletal Health in Bariatric Surgery Patients
Actual Study Start Date : March 22, 2018
Actual Primary Completion Date : August 2, 2020
Actual Study Completion Date : August 2, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Roux en Y Gastric Bypass Pre-menopausal
Pre-menopausal women undergoing Roux en Y Gastric Bypass
Procedure: Roux en Y Gastric Bypass Pre-menopausal
The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.

Roux en Y Gastric Bypass Post-menopausal
Post-menopausal women undergoing Roux en Y Gastric Bypass
Procedure: Roux en Y Gastric Bypass Post-menopausal
The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.

Sleeve Gastrectomy Pre-menopausal
Pre-menopausal women undergoing Sleeve Gastrectomy
Procedure: Sleeve Gastrectomy Pre-menopausal
The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.

Sleeve Gastrectomy Post-menopausal
Post-menopausal women undergoing Gastric Sleeve
Procedure: Sleeve Gastrectomy Post-menopausal
The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.




Primary Outcome Measures :
  1. Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women. [ Time Frame: Baseline ]
    Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density, BMD (in g/cm2) of the lumbar spine (L1-L4), total hip, femoral neck, distal radius, sub-total whole body (excluding only the head), and whole body. T scores will be evaluated and Z scores will be evaluated. T-scores between +1 and -1 is considered normal or healthy, T-scores between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis, T-scores of -2.5 or lower indicates that you have osteoporosis. For premenopausal women under the age of 50, the Z-score is used for diagnosis. Using the criteria defined by the International Society for Clinical Densitometry: If the Z-score is -2.0 or lower, the result will be below the expected range for age. If the Z score is above -2.0, the result is will be defined as within the expected range for age.

  2. Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women. [ Time Frame: Baseline to 12 months ]
    Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density, BMD (in g/cm2) of the lumbar spine (L1-L4), total hip, femoral neck, distal radius, sub-total whole body (excluding only the head), and whole body. T scores will be evaluated and Z scores will be evaluated. T-scores between +1 and -1 is considered normal or healthy, T-scores between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis, T-scores of -2.5 or lower indicates that you have osteoporosis. For premenopausal women under the age of 50, the Z-score is used for diagnosis. Using the criteria defined by the International Society for Clinical Densitometry: If the Z-score is -2.0 or lower, the result will be below the expected range for age. If the Z score is above -2.0, the result is will be defined as within the expected range for age.

  3. Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women. [ Time Frame: Baseline to 24 months ]
    Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density, BMD (in g/cm2) of the lumbar spine (L1-L4), total hip, femoral neck, distal radius, sub-total whole body (excluding only the head), and whole body. T scores will be evaluated and Z scores will be evaluated. T-scores between +1 and -1 is considered normal or healthy, T-scores between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis, T-scores of -2.5 or lower indicates that you have osteoporosis. For premenopausal women under the age of 50, the Z-score is used for diagnosis. Using the criteria defined by the International Society for Clinical Densitometry: If the Z-score is -2.0 or lower, the result will be below the expected range for age. If the Z score is above -2.0, the result is will be defined as within the expected range for age.

  4. Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Baseline ]
    Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)

  5. Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Baseline to 12 months ]
    Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)

  6. Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Baseline to 24 months ]
    Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)

  7. TBS adjustment of FRAX scores for an enhanced fracture risk probability in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Baseline ]
    The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to fracture risk. Trabecular Bone Score (TBS) software will be used to adjust fracture risk (FRAX) scores to obtain TBS scores (in gradient risk). FRAX adjusted TBS scores (in gradient of risk) ranges from 1.1% -1.9% coefficient of variation (C.V.)

  8. TBS adjustment of FRAX scores for an enhanced fracture risk probability in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Change from baseline to 12 months ]
    The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to fracture risk. Trabecular Bone Score (TBS) software will be used to adjust fracture risk (FRAX) scores to obtain TBS scores (in gradient risk). FRAX adjusted TBS scores (in gradient of risk) ranges from 1.1% -1.9% coefficient of variation (C.V.)

  9. TBS adjustment of FRAX scores for an enhanced fracture risk probability in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Change from baseline to 24 months ]
    The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to fracture risk. Trabecular Bone Score (TBS) software will be used to adjust fracture risk (FRAX) scores to obtain TBS scores (in gradient risk). FRAX adjusted TBS scores (in gradient of risk) ranges from 1.1% -1.9% coefficient of variation (C.V.)

  10. TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Baseline ]
    The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. Trabecular Bone Score (TBS) software will be used to assess bone microstructure. TBS ≤1.2 defines degraded microarchitecture, TBS between 1.20 and 1.35 is partially degraded microarchitecture, and TBS ≥1.35 is considered normal.

  11. TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Change from baseline to 12 months ]
    The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. Trabecular Bone Score (TBS) software will be used to assess bone microstructure. TBS ≤1.2 defines degraded microarchitecture, TBS between 1.20 and 1.35 is partially degraded microarchitecture, and TBS ≥1.35 is considered normal.

  12. TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve). [ Time Frame: Change from baseline to 24 months ]
    The Trabecular Bone Score (TBS) is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. Trabecular Bone Score (TBS) software will be used to assess bone microstructure. TBS ≤1.2 defines degraded microarchitecture, TBS between 1.20 and 1.35 is partially degraded microarchitecture, and TBS ≥1.35 is considered normal.


Secondary Outcome Measures :
  1. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline ]
    Serum bone alkaline phosphatase (BALP in U/L) will be assayed

  2. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 6 months ]
    Serum bone alkaline phosphatase (BALP in U/L) will be assayed

  3. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 12 months ]
    Serum bone alkaline phosphatase (BALP in U/L) will be assayed

  4. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 24 months ]
    Serum bone alkaline phosphatase (BALP in U/L) will be assayed

  5. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline ]
    Osteocalcin (in ng/mL) will be assayed.

  6. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 6 months ]
    Osteocalcin (in ng/mL) will be assayed.

  7. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 12 months ]
    Osteocalcin (in ng/mL) will be assayed.

  8. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 24 months ]
    Osteocalcin (in ng/mL) will be assayed.

  9. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline ]
    Type 1 procollagen (P1NP, in mcg/L) will be assayed.

  10. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 6 months ]
    Type 1 procollagen (P1NP, in mcg/L) will be assayed.

  11. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 12 months ]
    Type 1 procollagen (P1NP, in mcg/L) will be assayed.

  12. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 24 months ]
    Type 1 procollagen (P1NP, in mcg/L) will be assayed.

  13. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline ]
    C-terminal telopeptide (CTX, in pg/mL) will be assayed.

  14. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 6 months ]
    C-terminal telopeptide (CTX, in pg/mL) will be assayed.

  15. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 12 months ]
    C-terminal telopeptide (CTX, in pg/mL) will be assayed.

  16. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 24 months ]
    C-terminal telopeptide (CTX, in pg/mL) will be assayed.

  17. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline ]
    Calcium (in mg/dL), albumin (in, g/dL) will be assayed.

  18. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 6 months ]
    Calcium (in mg/dL), albumin (in, g/dL) will be assayed.

  19. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 12 months ]
    Calcium (in mg/dL), albumin (in, g/dL) will be assayed.

  20. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 24 months ]
    Calcium (in mg/dL), albumin (in, g/dL) will be assayed.

  21. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline ]
    Parathyroid hormone (PTH, in pg/mL) will be assayed.

  22. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 6 months ]
    Parathyroid hormone (PTH, in pg/mL) will be assayed.

  23. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 12 months ]
    Parathyroid hormone (PTH, in pg/mL) will be assayed.

  24. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 24 months ]
    Parathyroid hormone (PTH, in pg/mL) will be assayed.

  25. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline ]
    25-OH vitamin D (in ng/mL) will be assayed.

  26. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 6 months ]
    25-OH vitamin D (in ng/mL) will be assayed.

  27. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 12 months ]
    25-OH vitamin D (in ng/mL) will be assayed.

  28. Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis. [ Time Frame: Baseline to 24 months ]
    25-OH vitamin D (in ng/mL) will be assayed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female bariatric surgery population scheduled to undergo Roux en Y Gastric Bypass or Gastric Sleeve Surgery.
Criteria

Inclusion Criteria:

  • Adult females ≥ 19 years scheduled to undergo bariatric surgery (Roux en Y Gastric Bypass or Gastric Sleeve Surgery)
  • Class II (BMI 35-39.9 kg/m2).
  • Class III obesity (BMI ≥ 40 kg/m2).
  • Scheduled to undergo bariatric surgery with the ability to provide informed consent.

Exclusion Criteria:

  • Patients with a history of thyroid disorders, thyroidectomy and levothyroxine use.
  • Patients with a history of known osteoporosis, steroid-induced osteoporosis, current or previous use of medications for osteoporosis.
  • Patients with a history of gastrointestinal malabsorption.
  • Patients with a history of renal diseases.
  • Patients with a history of current or previous use of corticosteroids.
  • Patients who have used tobacco products within a year of study enrollment.
  • Patients with surgically-induced menopause e.g. bilateral salpingo-oophorectomy.
  • Patients with a history of breast cancer, who have had or are currently on hormonal therapy or anti-hormonal therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331536


Locations
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United States, Alabama
UAB Kirklin Clinic Digestive Health Center
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
American Society for Metabolic and Bariatric Surgery
Investigators
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Principal Investigator: Jayleen G Grams, MD,PhD University of Alabama at Birmingham
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Responsible Party: Jayleen M. Grams, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03331536    
Other Study ID Numbers: IRB-300000701
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Fractures, Bone
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Wounds and Injuries