Osteoarthritis of the knee treated with knee alloplastic MedDRA version: 8.1 Level: LLT Classification code 10031200 Term: Osteoarthrosis, localized, primary, involving lower leg
Conditions
Interventions
Trade Name: Bonviva
Pharmaceutical Form: Tablet
INN or Proposed INN: IBANDRONIC ACID
CAS Number: 114084785
Trade Name: Bonviva
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: IBANDRONI
Sponsors
Ortopædkirurgisk Center, Aarhus Universitets Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women with knee osteoarthrosis 2. Men and women with sufficient bonequality allowing knee alloplastics. 3. Older that 18 years and younger than 74 years. Duly qualified. 4. Written concent. 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: 1. Patients with neuromuscular- or vascular diseases in the legs. 2. Patients whitch are peroperatively found not to be suited for TKA. 3. Patients with osteoporosis verified with preoperative DEXA. 4. Patients with sequela after earlier knee fracture. 5. Patients with earlier major knee surgery. 6. Women who are pregnant or prone to pregnant within 5 times the halftime of last given Ibandronic acid dose. 7. Patients with metabolic bonedisease. 8. Patients with rheumatoid arthritis. 9. Postmenopausale women treated with hormonal substitution. 10. Patients with a low creatinine-clearance (< 0,5 ml/s). 11. Patients with known hypocalcaemia. 12. Patients which are known allergic to ibandronic acid. 13. Patients undergoing intermittent or regular glucocorticoid treatment. 14. Patients with lactose intolerance (lactosis in tablets) 15. Patients with cancer. 16. Patients treated with radiotherapi or kemotherapi. 17. Patients with bad tooth status.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to estabilish whether topical- and systemic Ibandronic Acid increases the prosthetic fixation to the bone and increases the bone density close to the implant. Differences between the two adminitration ways is also evaluated.;Secondary Objective: ;Primary end point(s): 1: Bone mass density close to the implant assesed with DEXA scanning. 2: Prosthetic micromotion in the follow-up period. | — |
Countries
Denmark
Outcome results
None listed