Bariatric Surgery CandidatePhase 4NCT03424239
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
A Phase 4 study testing Zoledronic Acid, Calcium citrate + vitamin D and Vitamin D3 in people with Bariatric Surgery Candidate, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 100 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Zoledronic Acid, Calcium citrate + vitamin D and Vitamin D3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Jan 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men must be age ≥ 50
- Women must be age ≥ 25 and postmenopausal
- Planning to receive RYGB or SG surgery
Who cannot join
- Age < 25
- Prior bariatric surgery
- Weight ≥ 400 lbs
- Liver or renal disease
- Hypercalcemia, hypocalcemia, or hypomagnesemia
- Serum 25-hydroxyvitamin D < 20 ng/mL
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study for Zoledronic Acid to Prevent High-Turnover 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.
Read the detailed description
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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Zoledronic Acid, Calcium citrate + vitamin D, Vitamin D3
- Keywords
- Roux-en-Y gastric bypass, sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Also called National Drug Code (NDC) 25021-830-82
5mg zoledronic acid
Calcium citrate + vitamin DDietary supplement
Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3
Vitamin D3Dietary supplement
1000IU Vitamin D3 gummy
| Study group | Role | What they receive |
|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Experimental | 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. Receives: Drug: Zoledronic Acid; Dietary Supplement: Calcium citrate + vitamin D; Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Aug 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine W. Yu, Massachusetts General Hospital
- Investigators
- Elaine W Yu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424239
- Sponsor's protocol ID
- 2017P002081
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2018
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Zoledronic Acid to Prevent High-Turnover Bone Loss After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03424239
- Acronym / sponsor ID
- 2017P002081
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Roux-en-Y gastric bypass, sleeve gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
| Arm | Type | Receives |
|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Experimental | Drug: Zoledronic Acid, Dietary Supplement: Calcium citrate + vitamin D, Dietary Supplement: Vitamin D3Subjects 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. |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men must be age ≥ 50
- Women must be age ≥ 25 and postmenopausal
- Planning to receive RYGB or SG surgery
Key exclusion criteria (10 listed)
- Age < 25
- Prior bariatric surgery
- Weight ≥ 400 lbs
- Liver or renal disease
- Hypercalcemia, hypocalcemia, or hypomagnesemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic AcidAlso: National Drug Code (NDC) 25021-830-825mg zoledronic acid | Drug | Drug: Zoledronic Acid, Calcium+Vitamin D |
| Calcium citrate + vitamin DChewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3 | Dietary supplement | Drug: Zoledronic Acid, Calcium+Vitamin D |
| Vitamin D31000IU Vitamin D3 gummy | Dietary supplement | Drug: Zoledronic Acid, Calcium+Vitamin D |
Primary outcome
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.
5 secondary outcomes
Change in Total Hip Bone Mineral Density by DXA
Time frame: Baseline and 6 months
Change in Trabecular Spine Bone Mineral Density by QCT
Time frame: Baseline and 6 months
Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0
Time frame: 6 months
Change From Baseline of Femoral Neck Bone Density Measured by DXA
Time frame: Baseline and 6 months
Change From Baseline of Spine Bone Density Measured by DXA
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine W Yu, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic Acid, Calcium citrate + vitamin D and Vitamin D3 in people with Bariatric Surgery Candidate, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum CTX (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.