Bariatric Surgery Candidate, Bone Loss, Weight Loss
Conditions
Keywords
Bone Health
Brief 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.
Detailed description
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. Optional additional exploratory assessments include CT-derive bone health and blood-based biomarkers, as well as 12-month DXA, CT, and blood assessments. The Wake Forest WMC, under the direction of Drs. Ard and Fernandez, will serve as a source of recruitment for potential study participants.
Interventions
DRUGRisedronate Sodium 150 MG
Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
OTHERPlacebo
Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Sponsors
Wake Forest University
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Both participant and research associate charged with administering medication or placebo capsules will be blinded.
Intervention model description
This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Enrolled Participants That Completed All 24 Week Procedures | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat Pounds | 24 weeks | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition |
| Lean Pounds | 24 weeks | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition |
| Total Change in Femoral Neck Hip Density | Baseline and 24 weeks | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm\^2 |
| Total Change in Lumbar Spine Density | Baseline and 24 weeks | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm\^2 |
| Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density | 24 weeks | Total change in ultradistal radius density measure in g/cm\^2 |
| Trabecular Bone Score (TBS) | 24 weeks | TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS \>=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS \<=1.200 defines degraded microarchitecture |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Risedronate Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.
Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy. | 11 |
| Placebo Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.
Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy. | 13 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | Risedronate | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 7.7 | 57.3 years STANDARD_DEVIATION 5.7 | 55.7 years STANDARD_DEVIATION 6.7 |
| Race/Ethnicity, Customized Black | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 11 Participants | 19 Participants |
| Region of Enrollment United States | 11 participants | 13 participants | 24 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 |
| other Total, other adverse events | 4 / 11 | 3 / 13 |
| serious Total, serious adverse events | 1 / 11 | 0 / 13 |
Outcome results
Primary
Number of Enrolled Participants That Completed All 24 Week Procedures
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risedronate | Number of Enrolled Participants That Completed All 24 Week Procedures | 8 Participants |
| Placebo | Number of Enrolled Participants That Completed All 24 Week Procedures | 13 Participants |
Secondary
Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density
Total change in ultradistal radius density measure in g/cm\^2
Time frame: 24 weeks
Population: Three subjects were lost to follow up in the risedronate arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Risedronate | Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density | Radius 33 BMD (g/cm^2) | -0.002 g/cm^2 |
| Risedronate | Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density | Radius UD BMD (g/cm^2) | 0.000 g/cm^2 |
| Placebo | Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density | Radius 33 BMD (g/cm^2) | -0.016 g/cm^2 |
| Placebo | Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density | Radius UD BMD (g/cm^2) | -0.013 g/cm^2 |
Comparison: Pertaining to Radius 33 BMDp-value: 0.337Mixed Models Analysis
Comparison: Pertaining to Radius UD BMDp-value: 0.238Mixed Models Analysis
Secondary
Fat Pounds
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition
Time frame: 24 weeks
Population: 3 subjects were lost to follow up in the risedronate arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Risedronate | Fat Pounds | 45.6 pounds |
| Placebo | Fat Pounds | 40.6 pounds |
p-value: 0.048Mixed Models Analysis
Secondary
Lean Pounds
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition
Time frame: 24 weeks
Population: 3 subjects were lost to follow up in the risedronate arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Risedronate | Lean Pounds | 50.4 pounds |
| Placebo | Lean Pounds | 50.7 pounds |
p-value: 0.745Mixed Models Analysis
Secondary
Total Change in Femoral Neck Hip Density
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm\^2
Time frame: Baseline and 24 weeks
Population: Three subjects were lost to follow up in the risedronate arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Risedronate | Total Change in Femoral Neck Hip Density | -0.028 g/cm^2 |
| Placebo | Total Change in Femoral Neck Hip Density | -0.047 g/cm^2 |
p-value: 0.163Mixed Models Analysis
Secondary
Total Change in Lumbar Spine Density
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm\^2
Time frame: Baseline and 24 weeks
Population: Three subjects were lost to follow up in the risedronate arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Risedronate | Total Change in Lumbar Spine Density | 0.028 g/cm^2 |
| Placebo | Total Change in Lumbar Spine Density | -0.029 g/cm^2 |
p-value: 0.013Mixed Models Analysis
Secondary
Trabecular Bone Score (TBS)
TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS \>=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS \<=1.200 defines degraded microarchitecture
Time frame: 24 weeks
Population: Three subjects were lost to follow up in the risedronate arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Risedronate | Trabecular Bone Score (TBS) | 1.478 score on a scale |
| Placebo | Trabecular Bone Score (TBS) | 1.485 score on a scale |
p-value: 0.86Mixed Models Analysis