NCT03424239

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

Completed Phase 4 Results posted Last updated 29 April 2021

What this trial tests

Phase 4 trial testing Zoledronic Acid in Bariatric Surgery Candidate in 6 participants. Completed in 1 January 2020.

Timeline

1 August 2018

Primary endpoint
1 January 2020

1 January 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	6
Start date	1 August 2018
Primary completion	1 January 2020
Estimated completion	1 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Zoledronic Acid (ZOLEDRONIC ACID) — full drug profile →
• Calcium citrate + vitamin D
• Vitamin D3 (cholecalciferol) — full drug profile →

Conditions studied

• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →

Sponsor

Massachusetts General Hospital

Who can join

Adults 25 to 100, any sex, with Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Serum CTX Primary · 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.

Group	Value	95% CI
Drug: Zoledronic Acid, Calcium+Vitamin D	0.228	± 0.117

Change in Total Hip Bone Mineral Density by DXA Secondary · 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).

Group	Value	95% CI
Drug: Zoledronic Acid, Calcium+Vitamin D	-0.039	± 0.041

Change in Trabecular Spine Bone Mineral Density by QCT Secondary · Baseline and 6 months

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

Group	Value	95% CI
Drug: Zoledronic Acid, Calcium+Vitamin D	4.9	± 7.8

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

Group	Value	95% CI
Drug: Zoledronic Acid, Calcium+Vitamin D	0

Change From Baseline of Femoral Neck Bone Density Measured by DXA Secondary · 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).

Group	Value	95% CI
Drug: Zoledronic Acid, Calcium+Vitamin D	-0.038	± 0.032

Change From Baseline of Spine Bone Density Measured by DXA Secondary · 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).

Group	Value	95% CI
Drug: Zoledronic Acid, Calcium+Vitamin D	0.003	± 0.074

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 to 7 months, starting with pre-surgical drug administration and following until 24 weeks after surgery.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Drug: Zoledronic Acid, Calcium+Vitamin D

Serious: 1/4 (25%)

Deaths: 0/4

Serious adverse events (1 terms)

Reaction	System	Drug: Zoledronic Acid, Cal…
Vertigo	Ear and labyrinth disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Drug: Zoledronic Acid, Cal…
Fever and body aches	General disorders	—
Diverticulitis flair	Gastrointestinal disorders	—
Post-op GI pain	Gastrointestinal disorders	—
pseudogout flair	Immune system disorders	—

Most-reported serious reactions: Vertigo.

Data from ClinicalTrials.gov NCT03424239 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. MANAGEMENT OF ENDOCRINE DISEASE: Bone complications of bariatric surgery: updates on sleeve gastrectomy, fractures, and interventions.
   Beavers KM, Greene KA, Yu EW. · · 2020 · cited 24× · PMID 32869608 · DOI 10.1530/eje-20-0548
2. Zoledronic acid for prevention of bone loss in patients receiving bariatric surgery.
   Liu Y, Côté MM, Cheney MC, Lindeman KG, et al · · 2021 · cited 15× · PMID 33816718 · DOI 10.1016/j.bonr.2021.100760