Periprosthetic bone loss after total hip arthroplasty (THA) is the main factor in limiting the longevity of implants used för treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA may prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthetic loosening. We want to perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss.
Conditions
Interventions
Trade Name: Optinate Septimum
Product Name: Optinate Septimum
Pharmaceutical Form: Tablet
INN or Proposed INN: Risedronate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Orthopaedic department, Karolinska Institutet, Danderyd's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients waiting for total hip arthroplasty due to primary or secondary osteoarthritis of the hip. Patients between 40-70 years of age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with rhematoid arthritis or earlier infection of the hip Steroid treatment Bisphosphonate treatment Osteomalacia Hypocalcemia Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can risedronate given once weekly (35 mg) prevent periprothetic bone loss after uncemented total hip arthroplasty?;Secondary Objective: Can risedronate prevent loosening of the prosthesis and reduce the number of reoperations?;Primary end point(s): Periprosthetic bone remodeling quantified by dual-energy x-ray absoptiometry. | — |
Countries
Sweden
Outcome results
None listed