Phase 4
Completed N=24
Weight Loss With Risedronate for Bone Health
Bariatric Surgery Candidate · Bone loss · Weight Loss
Source: ClinicalTrials.gov NCT03411902 ↗
Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Jan 2021
Primary outcomePrimary: Number of Enrolled Participants That Completed All 24 Week Procedures — 8; 13 Participants
◆ Published Evidence
Emerging
11citations · ~2 / year
Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial.
Summary
This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT) examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical weight loss associated loss of bone mass and quality.
Linked Publications
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Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Enrolled Participants That Completed All 24 Week Procedures |
8; 13 | — |
| SECONDARY Fat Pounds |
45.6; 40.6 | 0.048 sig |
| SECONDARY Lean Pounds |
50.4; 50.7 | 0.745 |
| SECONDARY Total Change in Femoral Neck Hip Density |
-0.028; -0.047 | 0.163 |
| SECONDARY Total Change in Lumbar Spine Density |
0.028; -0.029 | 0.013 sig |
| SECONDARY Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density |
-0.002; -0.016; 0.000; -0.013 | 0.337 |
| SECONDARY Trabecular Bone Score (TBS) |
1.478; 1.485 | 0.860 |
Eligibility Criteria
Inclusion Criteria
- Subjects planning a sleeve gastrectomy procedure
- 40-79 yrs of age
- Willingness to provide informed consent
- Agreement to all study procedures and assessments
Exclusion Criteria
- Age 450 pounds
- Chronic anti-reflux treatment
- History of medical disorders known to affect bone metabolism
- Use of bone-active medications
- Known allergy to Risedronate
Data sourced from ClinicalTrials.gov (NCT03411902) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.