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| Name | Class |
|---|---|
| Wake Forest University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risedronate | Active Comparator | Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. |
|
| Placebo | Placebo Comparator | Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate Sodium 150 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Enrolled Participants That Completed All 24 Week Procedures | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fat Pounds | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition | 24 weeks |
| Lean Pounds | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition |
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Inclusion Criteria
Exclusion Criteria
Male and female
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| Name | Affiliation | Role |
|---|---|---|
| Kristen M Beavers, PhD | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University | Winston-Salem | North Carolina | 27106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33103032 | Derived | Swafford AA, Ard JD, Beavers DP, Gearren PC, Fernandez AZ, Ford SA, Greene KA, Kammire DE, Nesbit BA, Reed KK, Weaver AA, Beavers KM. Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial. JBMR Plus. 2020 Oct 2;4(10):e10407. doi: 10.1002/jbm4.10407. eCollection 2020 Oct. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Enrolled Participants That Completed All 24 Week Procedures | Posted | Count of Participants | Participants | 24 weeks |
|
baseline through 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thyroid cancer | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Beavers | Wake Forest School of Medicine | 336-758-5855 | beaverkm@wfu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2020 | Jul 30, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 1, 2020 | Dec 28, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 29, 2020 | Dec 29, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks
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Both participant and research associate charged with administering medication or placebo capsules will be blinded.
|
| Placebo | Other | 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. |
|
|
| 24 weeks |
| Total Change in Femoral Neck Hip Density | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm^2 | Baseline and 24 weeks |
| Total Change in Lumbar Spine Density | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm^2 | Baseline and 24 weeks |
| 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 | 24 weeks |
| 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 | 24 weeks |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Fat Pounds | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition | 3 subjects were lost to follow up in the risedronate arm | Posted | Mean | 95% Confidence Interval | pounds | 24 weeks |
|
|
|
|
| Secondary | Lean Pounds | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition | 3 subjects were lost to follow up in the risedronate arm | Posted | Mean | 95% Confidence Interval | pounds | 24 weeks |
|
|
|
|
| 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 | Three subjects were lost to follow up in the risedronate arm. | Posted | Mean | 95% Confidence Interval | g/cm^2 | Baseline and 24 weeks |
|
|
|
|
| Secondary | Total Change in Lumbar Spine Density | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm^2 | Three subjects were lost to follow up in the risedronate arm. | Posted | Mean | 95% Confidence Interval | g/cm^2 | Baseline and 24 weeks |
|
|
|
|
| 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 | Three subjects were lost to follow up in the risedronate arm. | Posted | Mean | 95% Confidence Interval | g/cm^2 | 24 weeks |
|
|
|
|
| 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 | Three subjects were lost to follow up in the risedronate arm. | Posted | Mean | 95% Confidence Interval | score on a scale | 24 weeks |
|
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| 4 |
| 11 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 3 | 13 |
| melanoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| gastroesophageal reflux disease exacerbation | Gastrointestinal disorders | Systematic Assessment |
|
| broken ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Broken humerus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 0.238 |
| Superiority |