Skeletal Health in Bariatric Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Menopause; Osteoporosis; Bariatric Surgery; Sleeve Gastrectomy; Premenopause; Roux En-Y Gastric Bypass
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Kirklin Clinic Digestive Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female bariatric surgery population scheduled to undergo Roux en Y Gastric Bypass or Gastric Sleeve Surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.	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.	Baseline
Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.	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.	Baseline to 12 months
Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.	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.	Baseline to 24 months
Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).	Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)	Baseline
Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).	Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)	Baseline to 12 months
Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).	Assessment of fracture risk using the WHO Fracture Risk Assessment Tool (FRAX) will be used to assess the 10-year fracture risk probability (in %)	Baseline to 24 months
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).	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.)	Baseline
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).	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.)	Change from baseline to 12 months
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).	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.)	Change from baseline to 24 months
TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).	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.	Baseline
TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).	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.	Change from baseline to 12 months
TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).	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.	Change from baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Serum bone alkaline phosphatase (BALP in U/L) will be assayed	Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Serum bone alkaline phosphatase (BALP in U/L) will be assayed	Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Serum bone alkaline phosphatase (BALP in U/L) will be assayed	Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Serum bone alkaline phosphatase (BALP in U/L) will be assayed	Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Osteocalcin (in ng/mL) will be assayed.	Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Osteocalcin (in ng/mL) will be assayed.	Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Osteocalcin (in ng/mL) will be assayed.	Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Osteocalcin (in ng/mL) will be assayed.	Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Type 1 procollagen (P1NP, in mcg/L) will be assayed.	Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Type 1 procollagen (P1NP, in mcg/L) will be assayed.	Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Type 1 procollagen (P1NP, in mcg/L) will be assayed.	Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Type 1 procollagen (P1NP, in mcg/L) will be assayed.	Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	C-terminal telopeptide (CTX, in pg/mL) will be assayed.	Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	C-terminal telopeptide (CTX, in pg/mL) will be assayed.	Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	C-terminal telopeptide (CTX, in pg/mL) will be assayed.	Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	C-terminal telopeptide (CTX, in pg/mL) will be assayed.	Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Calcium (in mg/dL), albumin (in, g/dL) will be assayed.	Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Calcium (in mg/dL), albumin (in, g/dL) will be assayed.	Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Calcium (in mg/dL), albumin (in, g/dL) will be assayed.	Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Calcium (in mg/dL), albumin (in, g/dL) will be assayed.	Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Parathyroid hormone (PTH, in pg/mL) will be assayed.	Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Parathyroid hormone (PTH, in pg/mL) will be assayed.	Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Parathyroid hormone (PTH, in pg/mL) will be assayed.	Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	Parathyroid hormone (PTH, in pg/mL) will be assayed.	Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	25-OH vitamin D (in ng/mL) will be assayed.	Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	25-OH vitamin D (in ng/mL) will be assayed.	Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	25-OH vitamin D (in ng/mL) will be assayed.	Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.	25-OH vitamin D (in ng/mL) will be assayed.	Baseline to 24 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: American Society for Metabolic and Bariatric Surgery
• Investigators: Principal Investigator: Jayleen G Grams, MD,PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Actual): August 2, 2020
• Study Completion (Actual): August 2, 2020

Study Registration Dates

• First Submitted: October 14, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis
• Other Study ID Numbers: IRB-300000701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No