Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 25 - 100 |
| Updated: | 11/14/2018 |
| Start Date: | August 1, 2018 |
| End Date: | January 1, 2021 |
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.
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.
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.
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-OH vitamin 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
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