Effect of zoledronic acid on osteoarthritis of the hip
Phase 1
- Conditions
- Investigated disease is osteoarthritis of the hip with concurrent Bone marrow lesionsTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2019-000757-31-NO
- Lead Sponsor
- South-east health region of Noway
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Hip Osteoarthritis. Bone marrow lesion > 1 cm. Age 50-80. pain VAS >4
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
Exclusion Criteria
kidney failure GFR <35. Age <50 or >80. Prosthesis on contralateral hip or ipsilateral knee. calcium or vitamin d deficiency. Use of other bone modulating medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect on pain, functional improvement and quality of life. To investigate bone quality with microindentation and cartilage degredation after treatment;Secondary Objective: To investigate the effect on pain, functional improvement and quality of life. To investigate bone quality with microindentation and histochemical analysis and cartilage degredation after treatment;Primary end point(s): Visual analog scale;Timepoint(s) of evaluation of this end point: 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): HOOS score.<br>Harris Hip Score<br>EQ-5D<br>Microindentation score<br>cartilage thickness on MRI<br>use of analgetics<br>change in bone turnover;Timepoint(s) of evaluation of this end point: 12 months