A Phase 4 interventional study of Zoledronic Acid and Calcium citrate + vitamin D in Bariatric Surgery Candidate, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 25 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Prevention
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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.
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.
Massachusetts General Hospital is the lead sponsor of 2,589 studies on the registry; 447 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Drug: Zoledronic Acid · Dietary Supplement: Calcium citrate + vitamin D · Dietary Supplement: Vitamin D3
5mg zoledronic acid
Also known as: National Drug Code (NDC) 25021-830-82
Drug pages: Calcium Citrate · Vitamin D
Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3
1000IU Vitamin D3 gummy
Change in Serum CTX
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.
Time frame: Baseline and 6 months
Change in Total Hip Bone Mineral Density by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
Change in Trabecular Spine Bone Mineral Density by QCT
Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT).
Time frame: Baseline and 6 months
Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0
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.
Time frame: 6 months
Change From Baseline of Femoral Neck Bone Density Measured by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
Change From Baseline of Spine Bone Density Measured by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
| Milestone | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Started | 6 |
| Baseline/zoledronic acid administration | 4 |
| 2 week post-op | 4 |
| 12 week post-op | 4 |
| 24 week post-op | 4 |
| Completed | 4 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| ng/ml | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Change in Serum CTX | 0.228 ± 0.117 |
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
| g/cm^2 | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Change in Total Hip Bone Mineral Density by DXA | -0.039 ± 0.041 |
Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT).
| mg/cm^3 | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Change in Trabecular Spine Bone Mineral Density by QCT | 4.9 ± 7.8 |
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.
| Participants | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0 | 0 |
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
| g/cm^2 | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Change From Baseline of Femoral Neck Bone Density Measured by DXA | -0.038 ± 0.032 |
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
| g/cm^2 | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Change From Baseline of Spine Bone Density Measured by DXA | 0.003 ± 0.074 |
Collected over 6 to 7 months, starting with pre-surgical drug administration and following until 24 weeks after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | 0/4 (0%) | 1/4 (25%) | 3/4 (75%) |
| Event | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| VertigoEar and labyrinth disorders | 1/4 |
| Event | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Fever and body achesGeneral disorders | 2/4 |
| Diverticulitis flairGastrointestinal disorders | 1/4 |
| Post-op GI painGastrointestinal disorders | 1/4 |
| pseudogout flairImmune system disorders | 1/4 |
| Age, Continuous(years) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Mean | 56.0 ± 10.0 |
| Sex: Female, Male(Participants) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Female | 4 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Weight(lb) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Mean | 226.0 ± 18.0 |
| BMI(kg/m^2) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Mean | 40.9 ± 2.0 |
| Subtotal body fat(kg) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Mean | 46.9 ± 4.2 |
| Subtotal body lean mass(kg) | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Mean | 49.8 ± 5.8 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in Jan 2020, 17 months.
Results were first posted in Apr 2021, 1 year 3 months after primary completion.
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Studies of the drug tested here: Zoledronic Acid
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