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Completed

NCT Number: NCT03424239

Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery

This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

25 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

The investigators are evaluating the ability of a single dose of zoledronic acid to improve bone outcomes after RYGB or SG surgery. The investigators have previously shown that RYGB and SG have negative effects on bone density, bone microarchitecture, and that bariatric procedures potentially increase the risk of fractures. The purpose of this study is to evaluate the safety and efficacy of zoledronic acid to prevent the high-turnover bone loss that occurs in adults who have chosen to undergo RYGB or SG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men must be age ≥ 50
  • Women must be age ≥ 25 and postmenopausal
  • Planning to receive RYGB or SG surgery

Exclusion criteria

  • Age < 25
  • Prior bariatric surgery
  • Weight ≥ 400 lbs
  • Liver or renal disease
  • Hypercalcemia, hypocalcemia, or hypomagnesemia
  • Serum 25-hydroxyvitamin 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

Treatment and study plan

Zoledronic acid

Drug

5mg zoledronic acid

Other names: National Drug Code (NDC) 25021-830-82

Calcium citrate + vitamin D

Dietary Supplement

Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3

Vitamin D3

Dietary Supplement

1000IU Vitamin D3 gummy

Primary outcomes

  1. Change in Serum CTX

    Time frame: Baseline and 6 months

    The primary aim of this study is to determine the postoperative changes in serum markers of bone turnover after a preoperative infusion of zoledronic acid. Serum C-terminal telopeptide of type 1 collagen (CTX) is marker of bone resorption.

Secondary outcomes

  1. Change in Total Hip Bone Mineral Density by DXA

    Time frame: Baseline and 6 months

    Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).

  2. Change in Trabecular Spine Bone Mineral Density by QCT

    Time frame: Baseline and 6 months

    Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT).

  3. Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0

    Time frame: 6 months

    Hypocalcemia, if detected, will be graded according to common terminology for adverse event criteria (CTCAE v.4). Adverse events considered related or possibly related are counted.

  4. Change From Baseline of Femoral Neck Bone Density Measured by DXA

    Time frame: Baseline and 6 months

    Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).

  5. Change From Baseline of Spine Bone Density Measured by DXA

    Time frame: Baseline and 6 months

    Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Pilot Study for Zoledronic Acid to Prevent High-Turnover Bone Loss After Bariatric Surgery

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2018
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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