Bariatric SurgeryNCT03331536

Skeletal Health in Bariatric Surgery Patients

An observational study of Bariatric Surgery and Osteoporosis, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Bariatric Surgery, Osteoporosis, Fractures, Bone
What is being tested?: Roux en Y Gastric Bypass Pre-menopausal, Roux en Y Gastric Bypass Post-menopausal and Sleeve Gastrectomy Pre-menopausal
Type of treatment: Surgery or procedure
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 22 Mar 2018to 2 Aug 2020
Phase: Observational
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 19 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UAB Kirklin Clinic Digestive Health Center
Birmingham, Alabama, 35233

Other trials in United States

About this study

Read the 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.

Conditions: Bariatric Surgery, Osteoporosis, Fractures, Bone, Roux En-Y Gastric Bypass, Sleeve Gastrectomy, Menopause
Being tested: Roux en Y Gastric Bypass Pre-menopausal, Roux en Y Gastric Bypass Post-menopausal, Sleeve Gastrectomy Pre-menopausal, Sleeve Gastrectomy Post-menopausal
Medical subject headings: Osteoporosis, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Roux en Y Gastric Bypass Pre-menopausalProcedure or surgery
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-menopausalProcedure or surgery
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-menopausalProcedure or surgery
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-menopausalProcedure or surgery
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.

Study groups in NCT03331536
Study group	Role	What they receive
Roux en Y Gastric Bypass Pre-menopausal		Pre-menopausal women undergoing Roux en Y Gastric Bypass Receives: Procedure: Roux en Y Gastric Bypass Pre-menopausal
Roux en Y Gastric Bypass Post-menopausal		Post-menopausal women undergoing Roux en Y Gastric Bypass Receives: Procedure: Roux en Y Gastric Bypass Post-menopausal
Sleeve Gastrectomy Pre-menopausal		Pre-menopausal women undergoing Sleeve Gastrectomy Receives: Procedure: Sleeve Gastrectomy Pre-menopausal
Sleeve Gastrectomy Post-menopausal		Post-menopausal women undergoing Gastric Sleeve Receives: Procedure: Sleeve Gastrectomy Post-menopausal

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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 %)
Measured: 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 %)
Measured: 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 %)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 24 months

Secondary outcomes (28)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20182 Aug 2020

First posted6 Nov 2017
Study start22 Mar 2018
Primary completion2 Aug 2020
Study completion2 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03331536
Sponsor's protocol ID: IRB-300000701
Status last verified: Aug 2020
First submitted: 14 Oct 2017
Last updated: 18 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence

All Bariatric Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Skeletal Health in Bariatric Surgery Patients
ClinicalTrials.gov ID: NCT03331536
Acronym / sponsor ID: IRB-300000701
Conditions: Bariatric Surgery, Osteoporosis, Fractures, Bone, Roux En-Y Gastric Bypass, Sleeve Gastrectomy, Menopause
Study type: Observational
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: American Society for Metabolic and Bariatric Surgery
Study start: 22 Mar 2018 (actual)
Primary completion: 2 Aug 2020 (actual)
Study completion: 2 Aug 2020 (actual)
First posted: 6 Nov 2017 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Roux en Y Gastric Bypass Pre-menopausal	–	Procedure: Roux en Y Gastric Bypass Pre-menopausalPre-menopausal women undergoing Roux en Y Gastric Bypass
Roux en Y Gastric Bypass Post-menopausal	–	Procedure: Roux en Y Gastric Bypass Post-menopausalPost-menopausal women undergoing Roux en Y Gastric Bypass
Sleeve Gastrectomy Pre-menopausal	–	Procedure: Sleeve Gastrectomy Pre-menopausalPre-menopausal women undergoing Sleeve Gastrectomy
Sleeve Gastrectomy Post-menopausal	–	Procedure: Sleeve Gastrectomy Post-menopausalPost-menopausal women undergoing Gastric Sleeve

Who may qualify

Ages: 19 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Female bariatric surgery population scheduled to undergo Roux en Y Gastric Bypass or Gastric Sleeve Surgery.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

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
Roux en Y Gastric Bypass Pre-menopausalThe 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.	Procedure or surgery	Roux en Y Gastric Bypass Pre-menopausal
Roux en Y Gastric Bypass Post-menopausalThe 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.	Procedure or surgery	Roux en Y Gastric Bypass Post-menopausal
Sleeve Gastrectomy Pre-menopausalThe 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.	Procedure or surgery	Sleeve Gastrectomy Pre-menopausal
Sleeve Gastrectomy Post-menopausalThe 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.	Procedure or surgery	Sleeve Gastrectomy Post-menopausal

Primary outcome

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.
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.
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.
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 %)
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 %)
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 %)
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.)
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.)
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.)
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.
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.
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.

28 secondary outcomes

Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 24 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 6 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 12 months
Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
Time frame: Baseline to 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.

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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.

Jayleen G Grams, MD,PhD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery and Osteoporosis, run by University of Alabama at Birmingham at 1 site in United States.

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 4 inclusion and 8 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: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03331536.

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 18 Aug 2020.