Status:
UNKNOWN
The Effect of Zoledronic Acid on Patients With Osteoarthritis of the Hip
Lead Sponsor:
Vestre Viken Hospital Trust
Collaborating Sponsors:
Hormone Laboratory, Aker University Hospital, Oslo, Norway
University of Oslo
Conditions:
Osteoarthritis, Hip
Eligibility:
All Genders
50-80 years
Phase:
PHASE3
Brief Summary
Hip Osteoarthritis (OA) is one of the most common diseases affecting the ageing population. No specific and safe treatment slowing the development of hip OA as reflected in reduced joint space narrowi...
Detailed Description
Background Hip Osteoarthritis (OA) is one of the most common diseases affecting the ageing population. No specific and safe treatment slowing the development of hip OA as reflected in reduced joint sp...
Eligibility Criteria
Inclusion
- Age 50-80
- Continuous worsening of hip pain with an onset of minimum 3 months
- Hip Pain intensity \>40mm on a visual analogue scale (VAS) ranging from 0 (no pain) to 100mm (maximal pain) during weight bearing for the last 7 days
- HHS \< 65 (Harris Hip Score)
- Hip OA fulfilling the ACR (American College of Rheumatology) criteria \[33\]
- Hip MRI scan showing large (\>1 cm diameter) Bone Marrow lesions (BMLs)
- Willing and able to consent and comply with the study protocol
Exclusion
- eGFR (estimated glomerular filtration rate) \< 35 ml/min or hypocalcemia
- Exposure to any treatment affecting bone other than Ca+D ( bisphosphonates, Denosumab teriparatide or continuous treatment of prednisolone)
- Diseases affecting bone and joints (i.e inflammatory joint diseases, osteonecrosis with segmental collapse and deformation, primary bone cancer or known skeletal metastases)
- Severe vitamin D deficiency (S-25(OH)D \< 25 nmol/l) has to be supplemented with Ca+D before zoledronic acid infusion
- Ipsilateral knee prosthesis
- Contralateral hip prosthesis
- Women of child bearing potential (WOCBP). Female participants must be in a postmenopausal state or permanent sterile.
- Hypersensitivity or previous allergic reaction to ZA or other bisphosphonates.
- Hypersensitivity or previous allergic reaction to Calcigran Forte (a calcium and vitamine D supplement) or Prednisolone
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04303026
Start Date
March 2 2020
End Date
June 30 2024
Last Update
October 24 2022
Active Locations (1)
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1
Martina Hansens Hospital
Sandvika, Norway