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Phase 2 N=10 Randomized Quadruple-blind Prevention

Healthy Body, Healthy Bones After Bariatric Surgery Trial

Bariatric Surgery Candidate · Bone Loss · Bone Resorption

Bottom Line

View on ClinicalTrials.gov: NCT04279392 ↗
Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in Hip Bone Mineral Density (BMD) — 0; -.03 g/cm2

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Zoledronic Acid 5 mg/Bag 100 ml Inj (Drug); Placebos (Drug)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
University of Nebraska
Primary completion
Dec 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Hip Bone Mineral Density (BMD)		 0; -.03 —
SECONDARY
Change in Lumbar Spine Bone Mineral Density (BMD)		 .06; .06 —
SECONDARY
Change in Trunk Lean Mass		 -2.7; -3.3 —
SECONDARY
Change in Trunk Fat Mass		 -1.0; -5.4 —
SECONDARY
Change in Weight		 -10.9; -22.7 —

Summary

One in three adults in the United States suffers from obesity. Bariatric surgery is an increasingly utilized and effective treatment for obesity and obesity-related comorbidities, however, the massive weight loss associated with bariatric surgery adversely affects bone leads to an increased risk of fracture. Bisphosphonate medications, such as zoledronic acid, are used to treat bone loss in patients with osteoporosis, and this study investigates whether this medication can prevent bone loss associated with surgical weight loss procedures.

Eligibility Criteria

Inclusion Criteria

  • Subjects planning a sleeve gastrectomy procedure at the University of Nebraska Medical Center (UNMC) Bariatric Center
  • Agreement to all study procedures and assessments
  • Women must be postmenopausal (FSH blood level > 30 mIU/m), or incapable of child-bearing

Exclusion Criteria

  • Prior bariatric surgery
  • < 19 years of age
  • Weight ≥ 350lbs
  • Liver or renal disease
  • Hypercalcemia, hypocalcemia, or hypomagnesemia
  • Serum 25-OH vitamin D < 20 ng/mL
  • History of bone-modifying disorders
  • Use of bone-active medications
  • Known sensitivity to bisphosphonates
  • Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 6 months
  • Current diagnosis of type 1 diabetes
  • Current malignancy
  • Autoimmune disease impacting bone (ex: Rheumatoid Arthritis)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04279392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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