Skelid (tiludronate disodium)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved March 1997

Specific Treatments:

Paget’s disease

Therapeutic Areas

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General Information

Skelid, an orally-administered medicine, has been approved for the treatment of Paget’s disease of bone, a common, potentially debilitating bone disease. Skelid, a new bisphosphonate, has been shown to be a strong inhibitor of bone resorption. It is administered once a day, either in the morning or at night, and is effective in a three-month dosage regimen, rather than the six-month regimen normally employed for other currently-marketed oral bisphosphonates.

Clinical Results

Studies submitted to the FDA show that Skelid can control the abnormal bone growth of Paget’s disease without interfering with the normal process of bone formation, as indicated by the mineralization rate, bone remodeling and bone turnover.

Side Effects

The most frequent adverse events in patients receiving Skelid included nausea, diarrhea and dyspepsia. Adverse events usually were mild and generally did not require discontinuation of therapy. Bisphosphonates may cause upper gastrointestinal disorders.

Additional Information

Paget’s disease is a chronic bone disease characterized by an excessive rate of bone remodeling, resulting in the formation of disorganized, enlarged and weakened bone structure. Second in prevalence only to osteoporosis as a bone disease, Paget’s affects an estimated 3 to 4% of the U.S. population over 50 years of age, and is equally common in men and in women.