Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty (PREVENT)

Danderyd Hospital

Status and phase: Completed; Phase 4

Conditions: Bone Loss

Treatments: Drug: Placebo; Drug: Risedronate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00772395

04-745/4

Details and patient eligibility

About

Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?

Full description

Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. We perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.

Enrollment: 78 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients on the waiting list for a total hip arthroplasty
• Primary osteoarthritis
• Osteoarthritis secondary to congenital dislocation of the hip

Exclusion criteria

• Rheumatoid arthritis
• Bisphosphonate treatment
• Osteomalacia
• Hypocalcemia
• Previous surgery of the affected hip

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

78 participants in 2 patient groups, including a placebo group

Risedronate

Active Comparator group

Treatment:

Drug: Risedronate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo