Zoledronic Acid comes in two formulations: 5 mg and 4 mg solutions, with different brand names:
Zometa for the 4 mg and Reclast and Aclasta for the 5 mg formulation.
It is the same component, but studies on osteoporosis were effected on the 5 mg product hence, approval was given for osteoporosis for the 5 mg formulation.
As for the 4 mg it is approved for Hypercalcemia of Malignancy and Multiple Myeloma and Metastatic Bone Lesions From Solid Tumors.
However, studies were conducted on osteoporosis with lower than 5 mg:
Dr Andrew Grey, from the University of Auckland in New Zealand studied the effect of 1.5 mg and 2.5 mg yearly on bone mineral density and fracture incidence in post-menopausal women and got encouraging results (ENDO 2011: The Endocrine Society 93rd Annual Meeting. Abstract OR29-3. Presented June 6, 2011.)
This seems to indicate that Zometa 4mg might be used for osteoporosis but awaits full approval.
Dr. Isho,
I agree with Dr. Khoury, entirely. The report of Dr. Andrew Grey (2011) is a valuable one.
In Spain, we have generic zoledronic acid at a really competitive price. What we do is to collect four patients with osteoporosis the same day and use five vials of "generic Zometa".
Zoledronic acid ( actually sodium zoledronate is an excellent drug to treat osteoporosis. Although it is approved for annual use in the USA, studies from New Zealand indicate that a single 5 mg infusion can suppress bone loss for up to 5 years.
Zoledronic Acid comes in two formulations: 5 mg (Aclasta) and 4 mg (Zometa) solutions, with different brand names.
Approval was given for osteoporosis for the Aclasta, and Zometa is approved for Hypercalcemia of Malignancy and Multiple Myeloma and Metastatic Bone Lesions From Solid Tumors.
.
We did switch to using the 4 mg dose a year ago since it cost much less than the 5 mg dose i.e. the 4mg formulation went generic first in the UK. This saved our hospital £100,000 in one year
The Grey study compared 2.5 mg with 5 mg showing very similar results for these 2 doses but there were no fracture data. Also the subjects in these studies had osteopenia rather than osteoporosis
On balance though we concluded that due to the cost savings, using 4 mg was justified until the 5 mg dose also became generic - which it now is in the UK
For those with borderline renal function I still prefer the 4 mg dose and occasionally use 2 mg for patients with poor renal function
Thanks a lot Frederick, Aleksandra, and Michael for your answers. Best regards
Zometa was approved by the Food and Drug Administration (FDA) for hypercalcemia of malignancy (Myeloma and bone metastasis of other neoplasm) in 2001.Indeed Zoledronic acid had substantial effects on bone resortion, researchers evaluated the agent for other indications, such as osteoporosis. Zoledronic acid, 4 mg, was studied for up to 5 years in postmenopausal women with low bone mineral density. Although the drug was well-tolerated and effective in decreasing biomarkers, further analysis of bone marker changes suggested that 4 mg was a suboptimal dose for a significant number of patients. A further study established the utility of zoledronic acid, 5 mg, administered annually for postmenopausal osteoporosis.
Hallo,
the use of 5mg vs 4mg dose is just to have different brand names and different package inserts for malignant and benign indications - that means it is really a "marketing gag" by Novartis.... If one looks in the literature, to my knowledge the phase 1/2 studies were pergormed
Sorry, my comment was "killed" by the system....
The phase 1/2 studies in osteoporosis and Paget's were performed with multiple dosages (0.25, 1, 2 and 4 mg) and numbers of injections. Only phase 3 was made with 5 mg.
Data in Paget's disease show response in nearly 100% of patients with only 1/152 patients relapsing wuring follow up of 6.5 years after ONE SINGLE INFUSION !
Article A Single Infusion of Zoledronic Acid Produces Sustained Remi...
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