Skeletal Health in Bariatric Surgery Patients

NCT03331536 | Completed

• 1 other identifier: IRB-300000701
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery; Osteoporosis; Fractures, Bone; Roux En-Y Gastric Bypass; Sleeve Gastrectomy; Menopause; Premenopause

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (28)

• Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.

  Baseline

• Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.

  Baseline to 6 months

• Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.

  Baseline to 12 months

• Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.

  Baseline to 24 months

• Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.

  Baseline

Study Arms (4)

Roux en Y Gastric Bypass Pre-menopausal

Pre-menopausal women undergoing Roux en Y Gastric Bypass

Procedure: Roux en Y Gastric Bypass Pre-menopausal

Roux en Y Gastric Bypass Post-menopausal

Post-menopausal women undergoing Roux en Y Gastric Bypass

Procedure: Roux en Y Gastric Bypass Post-menopausal

Sleeve Gastrectomy Pre-menopausal

Pre-menopausal women undergoing Sleeve Gastrectomy

Procedure: Sleeve Gastrectomy Pre-menopausal

Sleeve Gastrectomy Post-menopausal

Post-menopausal women undergoing Gastric Sleeve

Procedure: Sleeve Gastrectomy Post-menopausal

Interventions

Roux en Y Gastric Bypass Pre-menopausal PROCEDURE

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 Pre-menopausal

Roux en Y Gastric Bypass Post-menopausal PROCEDURE

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.

Roux en Y Gastric Bypass Post-menopausal

Sleeve Gastrectomy Pre-menopausal PROCEDURE

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 Pre-menopausal

Sleeve Gastrectomy Post-menopausal PROCEDURE

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.

Sleeve Gastrectomy Post-menopausal

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Society for Metabolic and Bariatric Surgery: collaborator

Study Sites (1)

UAB Kirklin Clinic Digestive Health Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Jayleen G Grams, MD,PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2017
• First Posted: November 6, 2017
• Study Start: March 22, 2018
• Primary Completion: August 2, 2020
• Study Completion: August 2, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

US (1)