Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04922333
Phase
PHASE3
Status
Recruiting
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Conditions

  • Bone Loss

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Risedronate — DRUG
    150mg over-encapsulated risedronate
  • Placebo — DRUG
    Capsules containing placebo tablets

Study Details

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).

Key Dates

Start date
Mar 28, 2023
Status verified
Dec 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Bisphosphonate
    Participants in this arm will receive six months of 150 mg once monthly oral risedronate
  • Placebo Comparator: Placebo
    Participants in this arm will receive six months of placebo

Primary Outcome Measure

Change in Total Hip Areal Bone Mineral Density (aBMD) [ Time Frame: baseline through Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest School of MedicineWinston-SalemNorth Carolina27157
Kristen Beavers, PhD, MPH, RD
[email protected]
336-758-5855
Lori Cogdill, MS
[email protected]
336-758-5044
Kristen Beavers, PhD, MPH, RD (PRINCIPAL_INVESTIGATOR)

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Wake Forest School of Medicine· Winston-Salem, NC

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