Weight Loss With Risedronate for Bone Health
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Orthopedic |
| Therapuetic Areas: | Endocrinology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 40 - 79 |
| Updated: | 4/6/2019 |
| Start Date: | June 15, 2018 |
| End Date: | January 2020 |
| Contact: | Kristen M Beavers, PhD |
| Email: | beaverkm@wfu.edu |
| Phone: | 336-758-5855 |
Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity
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.
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.
This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo
capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be
approached during their pre-surgical evaluation for possible participation in the study.
Eligible participants will be referred onto the study coordinator to read/sign an
IRB-approved informed consent prior to enrollment.
Two in-person baseline assessment visits [baseline visit 1 (BV1), baseline visit 2 (BV2)]
occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits [follow
up visit 1 (FV1) and follow up visit 2 (FV2)] occurring ±2 weeks from their 23-week
post-surgery date will be conducted, as well as monthly medication compliance reminders and
adverse event reporting via phone. The Wake Forest WMC, under the direction of Drs. Ard and
Fernandez, will serve as a source of recruitment for potential study participants.
capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be
approached during their pre-surgical evaluation for possible participation in the study.
Eligible participants will be referred onto the study coordinator to read/sign an
IRB-approved informed consent prior to enrollment.
Two in-person baseline assessment visits [baseline visit 1 (BV1), baseline visit 2 (BV2)]
occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits [follow
up visit 1 (FV1) and follow up visit 2 (FV2)] occurring ±2 weeks from their 23-week
post-surgery date will be conducted, as well as monthly medication compliance reminders and
adverse event reporting via phone. The Wake Forest WMC, under the direction of Drs. Ard and
Fernandez, will serve as a source of recruitment for potential study participants.
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 <40 years
- Baseline weight >450 pounds
- Chronic anti-reflux treatment
- History of medical disorders known to affect bone metabolism
- Use of bone‐active medications
- Known allergy to Risedronate
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