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

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

Treatments tested in this trial

  • Risedronate
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

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

Collaborator