Background/Purpose: No disease modifying drugs exists to treat osteoarthritis.  Recently, a phase II study from Tasmania showed that Zoledronic Acid, a bisphosphonate, has an effect on decreasing bone marrow lesions in patients with osteoarthritis of the knee.  However, this was associated with post-dose syndrome with the once-a-year infusion. A new combination of Zoledronic Acid and an established drug, Volt01, was devised to decrease the post-dose syndrome.

Methods: In a single blind study (patients were blinded), 36 subjects with knee OA were given a single intravenous infusion of either Zoledronic Acid or Volt01 in a 1:1 ratio.  Patients who had bilateral knee OA had the worse joint selected as the index joint.  No patient with knee OA was rejected based on severity of OA.    Patients with concomitant diseases were excluded.  Patients were evaluated at baseline with the visual analogue pain score (VAS) and bone mineral density with a DEXA scan.  VAS was evaluated at 1 month, 3 months, and six months.  DEXA scan was repeated at six months to confirm no decrease in BMD.    

Results: At six months, after a single infusion, there was no difference in bone mineral density in either cohort.  The number of patients complaining of post-dose syndrome in the cohort treated with Zoledronic Acid was significantly worse that in those treated with Volt01 (9/16 versus 2/16).  The improvement in pain as measured by VAS at six months was also significantly better in the Volt01 cohort than the Zoledronic Acid cohort (-35mm versus -10mm)

Cohort	PDS (# reporting/total)	DBMD	D Mean VAS
ZA=16	9/16	0	-10 mm
VOLT01 =16	2/16	0	-35 mm

Conclusion: Zoledronic Acid has been recently shown to have disease modifying properties in a large phase II study in patients with OA of the knee.  In the study presented in this abstract, Volt01, a new combination with Zoledronic Acid, was both safer and more effective than Zoledronic acid after a single infusion in patients with knee OA for at least six months.  Volt01 thus has the potential to be a disease modifying drug for knee OA.  Larger studies using MRI will need to be undertaken to confirm this observation.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/exploratory-six-month-phase-iia-study-of-a-potential-disease-modifying-drug-in-patients-with-oa-of-the-knee/