All GLG News Analyses Filed Under: Orthopaedics

The news is obviously reporting a cautionery measure by the FDA to assess the report of abnormal heart beat after using bisphosphonates - a class of osteoporosis drugs, and as such, the report has a significant influence on the continuity of this drug. To ensure the drug's safeguard, FDA is...

-Decrease Mortality -Decrease Medical Costs -

SERMS work for osteoporosis but probably are not as good as bisphosphonates. This is another SERM. How will it compare to Evista which now has further indications re Breast Cancer?

This is approvable if the safety profile is beneficial.

The data are intriguing, and the product is certainly interesting.

The therapeutic use of a group of drugs known as bisphosphonates has been associated with a rare but destructive outcome termed osteonecrosis of the jaws (also osteonecrosis of the mandible/osteonecrosis of the maxilla.) Numerous case series and case reports have attempted to describe this phenomenon...

The design of this trial, which compares daily 5 mg Actonel (risedronate) to a monthly 150 mg dosage, is likely to demonstrate equivalence. First, the study uses risedronate 5 mg as an active control, without a placebo arm: this is appropriate, as the purpose of the study is not to demonstrate...

Although Reclast is an innovative drug, the way its investigators present its data makes it look better than it really is. For instance, the study claims that Reclast achieved a 35% reduction in fractures.  Upon closer review, the placebo group had a 13.9% risk of fracture, while the Reclast group...

Reclast sounds like a promising new drug.  Although many osteoporosis drugs are currently on the market, this is the only one that has shown such a dramatic decrease in the recurrence of fractures, which is definitely a plus.  In terms of compliance, it is also very innovative, because...

This is a very promising study. If post-marketing does not show a major problem with new onset A-fib., this will be a great therapy.