A Phase 4 interventional study of Risedronate Sodium 150 MG and Placebo in Bariatric Surgery Candidate, Bone Loss and Weight Loss, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 40 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Supportive care
Among 17 studies testing Risedronic Acid in Bone Diseases, Metabolic — 1 open to participants now, 1 under way, 1 of them phase 3. Risedronic Acid · Bone Diseases, Metabolic.
Among the 17 studies testing Risedronic Acid in Bone Diseases, Metabolic, this one is the 13th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2018, is one of 7 in phase 4, and was the 15th registered.
661 studies on the registry are indexed under Bone Diseases, Metabolic; 93 are open to participants now.
Browse Bone Diseases, Metabolic studies →1 of the 17 studies testing Risedronic Acid in Bone Diseases, Metabolic is open now, in 1 country. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
By country, each count listing its studies:
Risedronic Acid: first FDA approval 1998 (ACTONEL). What it is approved for, and how studies give it, is on its page →
Of the 63 Bone Diseases, Metabolic studies recruiting now, 27 (43%) set no upper age limit and 28 (44%) stop at 75 or younger; 12 take children under 18; 22 take healthy volunteers.
This study: 40 Years to 79 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1 · Phase 3 6 · Phase 4 7
First in 2002; this study’s year is marked. 1 started in 2018.
This study's enrollment of 24 is below the median of 60 across 509 interventional studies indexed under Bone Diseases, Metabolic.
Median enrollment 78 across the 16 interventional studies. Of the 15 that completed or were terminated, 8 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 17 have an industry lead sponsor. The 10 most frequent:
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Wake Forest University Health Sciences has 4 studies filed under Bone Diseases, Metabolic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies testing Risedronic Acid in Bone Diseases, Metabolic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.
Drug: Risedronate Sodium 150 MG
Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.
Other: Placebo
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.
Also known as: Code A
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.
Also known as: Code B
Number of Enrolled Participants That Completed All 24 Week Procedures
Time frame: 24 weeks
Fat Pounds
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition
Time frame: 24 weeks
Lean Pounds
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 weeks
| Milestone | Risedronate | Placebo |
|---|---|---|
| Started | 11 | 13 |
| Completed | 8 | 13 |
| Not completed | 3 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Participants | Risedronate | Placebo |
|---|---|---|
| Number of Enrolled Participants That Completed All 24 Week Procedures | 8 | 13 |
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition
| pounds | Risedronate | Placebo |
|---|---|---|
| Fat Pounds | 45.6 (41.8 to 49.4) | 40.6 (37.9 to 43.4) |
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition
| pounds | Risedronate | Placebo |
|---|---|---|
| Lean Pounds | 50.4 (49.1 to 51.8) | 50.7 (49.7 to 51.7) |
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm\^2
| g/cm^2 | Risedronate | Placebo |
|---|---|---|
| Total Change in Femoral Neck Hip Density | -0.028 (-0.049 to -0.006) | -0.047 (-0.063 to -0.030) |
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm\^2
| g/cm^2 | Risedronate | Placebo |
|---|---|---|
| Total Change in Lumbar Spine Density | 0.028 (-0.006 to 0.063) | -0.029 (-0.054 to -0.004) |
Total change in ultradistal radius density measure in g/cm\^2
| g/cm^2 | Risedronate | Placebo |
|---|---|---|
| Radius 33 BMD (g/cm^2) | -0.002 (-0.027 to 0.023) | -0.016 (-0.036 to 0.004) |
| Radius UD BMD (g/cm^2) | 0.000 (-0.017 to 0.017) | -0.013 (-0.026 to 0.001) |
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
| score on a scale | Risedronate | Placebo |
|---|---|---|
| Trabecular Bone Score (TBS) | 1.478 (1.413 to 1.543) | 1.485 (1.436 to 1.533) |
Collected over baseline through 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Risedronate | 0/11 (0%) | 1/11 (9.1%) | 4/11 (36.4%) |
| Placebo | 0/13 (0%) | 0/13 (0%) | 3/13 (23.1%) |
| Event | Risedronate | Placebo |
|---|---|---|
| thyroid cancerEndocrine disorders | 1/11 | 0/13 |
| melanomaSkin and subcutaneous tissue disorders | 1/11 | 0/13 |
| Event | Risedronate | Placebo |
|---|---|---|
| psoriasisSkin and subcutaneous tissue disorders | 1/11 | 0/13 |
| nauseaGastrointestinal disorders | 1/11 | 1/13 |
| broken ankleMusculoskeletal and connective tissue disorders | 1/11 | 0/13 |
| Broken humerusMusculoskeletal and connective tissue disorders | 1/11 | 0/13 |
| headacheNervous system disorders | 0/11 | 1/13 |
| gastroesophageal reflux disease exacerbationGastrointestinal disorders | 0/11 | 1/13 |
| Age, Continuous(years) | Risedronate | Placebo | Total |
|---|---|---|---|
| Mean | 53.8 ± 7.7 | 57.3 ± 5.7 | 55.7 ± 6.7 |
| Sex: Female, Male(Participants) | Risedronate | Placebo | Total |
|---|---|---|---|
| Female | 9 | 11 | 20 |
| Male | 2 | 2 | 4 |
| Race/Ethnicity, Customized(Participants) | Risedronate | Placebo | Total |
|---|---|---|---|
| Black | 3 | 2 | 5 |
| White | 8 | 11 | 19 |
| Region of Enrollment(participants) | Risedronate | Placebo | Total |
|---|---|---|---|
| United States | 11 | 13 | 24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Jul 2020, 25 months.
Results were first posted in Jan 2021, 6 months after primary completion.
Of 30 phase 4 interventional studies under Bone Diseases, Metabolic, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 64. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Risedronic Acid
Wake Forest University Health Sciences →