Healthy Body, Healthy Bones After Bariatric Surgery Trial

NCT04279392 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 0820-19-FB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery Candidate; Bone Loss; Bone Resorption

Outcome Measures

Primary Outcomes (1)

• Change in Hip Bone Mineral Density (BMD)

  Change in hip bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) - g/cm2

  baseline and 10 months post-surgery

Secondary Outcomes (4)

• Change in Lumbar Spine Bone Mineral Density (BMD)

  baseline and 10 months post-surgery

• Change in Trunk Lean Mass

  baseline and 9 months post-surgery

• Change in Trunk Fat Mass

  baseline and 9 months post-surgery

• Change in Weight

  baseline and 9 months post-surgery

Other Outcomes (2)

• Proportion of Participants Completing 9 Month Study Visit Requirements

  9 Months

• Tolerance: Total Number of Adverse Events Reported by Participants in the Active and In-active Arms

  9 Months

Study Arms (2)

Active Infusion

ACTIVE COMPARATOR

At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.

Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj

Non-active Infusion

PLACEBO COMPARATOR

At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.

Drug: Placebos

Interventions

Zoledronic Acid 5 mg/Bag 100 ml Inj DRUG

Zoledronic acid infusion

Also known as: Reclast

Active Infusion

Placebos DRUG

Saline infusion

Non-active Infusion

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Bariatric Center, Nebraska Medicine

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Flores LE, Mack L, Wichman C, Weaver AA, Kothari V, Bilek LD. Protocol for a pilot randomised controlled trial of zoledronic acid to prevent bone loss following sleeve gastrectomy surgery. BMJ Open. 2021 Dec 9;11(12):e057483. doi: 10.1136/bmjopen-2021-057483.

  PMID: 34887285 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Bone Resorption

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Laura Bilek
• Organization: University of Nebraska Medical Center

lbilek@unmc.edu

402-690-3524

Study Officials

• Laura D Bilek, PT, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research pharmacist will deliver the drug pr placebo to the treatment nurse in an unlabeled 100 ml saline bag for infusion.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this randomized controlled trial each subject will be randomized (1:1, block randomization with a block size of 10) to one treatment group (Active or Inactive treatment) and will be considered part of the intent-to-treat (ITT) cohort. The research pharmacist will be responsible for completing the randomization process, and will hold the group assignment data. All other study personnel will be blinded to group assignment.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 21, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 24, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 06/30/2024
• Access Criteria: Approval from the PI

Locations

US (1)