Reclast (zoledronic acid)

Company
Novartis

Approval Status
Approved April 2007

Treatment for
Paget's disease

Possible similar drugs
Reclast

Areas
Musculoskeletal

Reclast is a bisphosphonic acid inhibitor of osteoclastic bone resorption. Once administered, it rapidly moves to bone and preferentially localizes at sites of high bone turnover.

Reclast is specifically indicated for the treatment of Paget's disease of bone in men and women.

Reclast is supplied as a sterile solution designed for intravenous infusion. The recommended initial dose of the drug is a 5 mg infusion administered intravenously via a vented infusion line. The infusion time must not be less than 15 minutes given over a constant infusion rate.

FDA Approval
FDA approval of Reclast was based on the results of two 6- month randomized, double blind trials. Subjects enrolled in the studies received one infusion of 5-mg Reclast or oral daily doses of 30 mg-risedronate for 2 months. Therapeutic response was defined as either normalization of serum alkaline phosphatase (SAP) or a reduction of at least 75% from baseline in total SAP excess at the end of 6 months. SAP excess was defined as the difference between the measured level and midpoint of normal range. Combined data showed that 96% of the subjects treated with Reclast achieved therapeutic response compared to 74% of those treated with risedronate. At six months, 89% of the Reclast treated subjects achieved normalization of SAP levels versus 58% of those treated with risedronate (p<0.0001). In subjects who had previously received treatment with oral bisphosphonates, 96% reached therapeutic response rates compared to 55% for risedronate. In treatment naïve subjects, therapeutic response to Reclast was 98% compared to 86% of those receiving risedronate. In subjects with symptomatic pain at screening, therapeutic response rates were 94% and 70% for Reclast and risedronate respectively. For subjects without pain at screening, therapeutic response rates were 100% and 82% for Reclast and risedronate respectively.

Ongoing Study Commitments

  • Novartis has agreed to perform a registry study to determine the incidence of hypocalcemia post Reclast treatment in patients with Paget’s Disease.
    Protocol Submission: September 2007
    Study Start: March 2008
    Final Report Submission: September 2010

Adverse events associated with the use of Reclast may include, but are not limited to, the following:

  • Influenza like illness
  • Headache
  • Dizziness
  • Nausea
  • Arthralgia
  • Bone pain
  • Pyrexia

Reclast is a bisphosphonic acid inhibitor of osteoclastic bone resorption. Once administered, it rapidly moves to bone and preferentially localizes at sites of high bone turnover. The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase which catalyses the formation of a key cellular intermediate in isoprenoid metabolic pathways.

For additional information regarding Reclast or Paget's disease, please visit the Reclast web page.

Reclast (zoledronic acid) Drug Information

The Reclast (zoledronic acid) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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