Status:
COMPLETED
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Bariatric Surgery Candidate
Eligibility:
All Genders
25-100 years
Phase:
PHASE4
Brief 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.
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 negati...
Eligibility Criteria
Inclusion
- Men must be age ≥ 50
- Women must be age ≥ 25 and postmenopausal
- Planning to receive RYGB or SG surgery
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03424239
Start Date
August 1 2018
End Date
January 1 2020
Last Update
April 29 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114