Clinical trial NCT03331536: Skeletal Health in Bariatric Surgery Patients
Official title: Skeletal Health in Bariatric Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Osteoporosis
Fractures, Bone
Roux En-Y Gastric Bypass
Sleeve Gastrectomy
Menopause
Premenopause
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Society for Metabolic and Bariatric Surgery
First posted: 2017-11-06
Enrollment: 27
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female bariatric surgery population scheduled to undergo Roux en Y Gastric Bypass or Gastric Sleeve Surgery.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.
timeFrame: Baseline
measure: Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in bone mineral density after bariatric surgery (Roux en Y vs. Gastric Sleeve) in pre- and post-menopausal women.
timeFrame: Baseline to 24 months
measure: Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
timeFrame: Baseline
measure: Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
timeFrame: Baseline to 12 months
measure: Fracture risk assessment in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
timeFrame: Baseline to 24 months
measure: 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).
timeFrame: Baseline
measure: 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).
timeFrame: Change from baseline to 12 months
measure: 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).
timeFrame: Change from baseline to 24 months
measure: TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
timeFrame: Baseline
measure: TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
timeFrame: Change from baseline to 12 months
measure: TBS assessment of bone microstructure in pre and post-menopausal women undergoing bariatric surgery (Roux en Y vs. Gastric Sleeve).
timeFrame: Change from baseline to 24 months
Secondary outcomes:
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 6 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 24 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 6 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 24 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 6 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 24 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 6 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 24 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 6 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 24 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 6 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 24 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 6 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 12 months
measure: Determine and quantify changes in biochemical markers of bone metabolism and calcium homeostasis.
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Kirklin Clinic Digestive Health Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jayleen G Grams, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: