NCT00477217WithdrawnPhase 2
A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Novartis
- Locations
- 1
- Primary Endpoint
- Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
Study Overview
Brief Summary
This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults 40-85 years of age
- •Diagnosis of painful osteonecrosis of the knee within the last month.
Exclusion Criteria
- •Intravenous (iv) bisphosphonates within the last 2 years.
- •Abnormal thyroid, kidney or liver function.
- •Abnormal blood calcium or alkaline phosphatase levels.
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
1
Other
Intervention: Zoledronic acid (Drug)
Outcomes
Primary Outcomes
Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
Time Frame: 3 months
Secondary Outcomes
- Changes from baseline after 6 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.(6 months)
- Safety as assessed by adverse events.
Investigators
Study Sites (1)
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