Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

ConditionBone Loss
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30+
SponsorWake Forest University Health Sciences

About this trial

The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy.

Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who have had sleeve gastrectomy

Willing to provide informed consent

Agree to all study procedures and assessments.

Disqualifiers

Weight greater than 450 lbs

Regular use of growth hormones, oral steroids, or prescription osteoporosis medications;

Known allergies to bisphosphonates

Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Risedronate

    Drug

    150mg over-encapsulated risedronate

  • Placebo

    Drug

    Capsules containing placebo tablets

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: BisphosphonateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Total Hip Areal Bone Mineral Density (aBMD)

Acquired through DXA scans.

Time frame
baseline through Month 6
2

Change in Total Hip Areal Bone Mineral Density (aBMD)

Acquired through DXA scans.

Time frame
baseline through Month 12

Secondary outcomes

1

Dual Energy X-Ray Absorptiometry (DXA)-acquired Femoral Neck Measurements

Time frame
Baseline, Month 6, Month 12
2

DXA-acquired Lumbar Spine Measurements

Time frame
Baseline, Month 6, Month 12
3

DXA-acquired Distal Radius Areal BMD Measurements

Time frame
Baseline, Month 6, Month 12
4

DXA-acquired Appendicular Lean Mass Measurements

Time frame
Baseline, Month 6, Month 12

Other outcomes

1

Biomarkers of Bone Turnover, Metabolism, and Bone-Muscle Crosstalk

Blood drawn for collection of biomarkers.

Time frame
Baseline, Month 6, Month 12
2

High Resolution peripheral Quantitative Computed Tomography (HRpQCT)-Acquired Distal Tibia Failure Load

Time frame
Baseline, Month 6, Month 12
3

HRpQCT-Acquired Distal Tibia Bones Stiffness

Time frame
Baseline, Month 6, Month 12
4

HRpQCT-Acquired Distal Radius Failure Load

Time frame
Baseline, Month 6, Month 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator