Etidronate, a synthetic analog of pyrophosphate, is used in the treatment
of moderate to severe Paget's disease, heterotopic ossification, and hypercalcemia
associated with malignant neoplasms. In Paget's disease, etidronate therapy
is usually reserved for patients with moderate to severe pain, and, although
the drug does not appear to be effective in asymptomatic patients, therapy may
be considered for asymptomatic patients who are at risk for developing extensive
neurological damage or who have extensive bone disease involvement that could
jeopardize the joints. It was approved by the FDA in 1977. Use of etidronate
in the treatment of osteoporosis was denied by the FDA twice, first in 1991,
and again in November 1994.1
Tiludronate is
an oral bisphosphonate approved for use in the US for the treatment of Paget's
disease. The drug controls abnormal bone growth of Paget's disease without
interfering with the normal process of bone formation. Several open uncontrolled,
open randomised, and double-blind, placebo-controlled studies carried out
in patients with active Paget's disease have demonstrated that tiludronate
reduces bone pain and produces an intense and sustained biochemical response.
3-6 months after starting tiludronate therapy, serum alkaline phosphatase
levels fall far more than 50% from baseline values, reaching normal values
in a percentage of the cases ranging from 35-70%. 2