All GLG News Analyses Filed Under: Orthopaedics

New Osteoporosis Drug Reduces Mortality after Hip Fracture without increase in Cardiovascular Events

October 5, 2007

Analysis by: GLG Expert Contributor

Analysis of:U.S. reviews osteoporosis drugs' effect on heart | www.reuters.com

 In a recent hip fracture intervention trial released on the New England Journal of Medicine website by Lyles, et al on Sept 17,2007 (not scheduled to be released in print until Nov 1 2007) Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture   A placebo controlled study with over 2000 subjects there was no increase in atrial fibrillation or other cardiovascular events in the treated group compared to the placebo group.  This was an extension of the HORIZON data published in the NEJM earlier this year.

Novartis and others beware!

October 5, 2007

Analysis by: GLG Expert Contributor

Analysis of:U.S. reviews osteoporosis drugs' effect on heart | www.reuters.com

Abnormal heart beats from bisphosphonates (Roche Holding AG and GlaxoSmithKline PLC's Boniva; Actonel, sold by Procter & Gamble and Sanofi-Aventis; Novartis AG's Zometa and Aredia; P&G's Didronel, and Sanofi's Skelid  and Merck & Co Inc's Fosamax or Novartis AG's Reclast) could prompt the FDA to limit use.

Atrial Fibrillation with Bisphosphonates

October 5, 2007

Analysis by: GLG Expert Contributor

Analysis of:U.S. reviews osteoporosis drugs' effect on heart | www.reuters.com

So far, this has been noted with only some of the bisphosphonates.

Bisphosphonates cause abnormal heartbeat:should patient continue to use it?

October 4, 2007

Analysis by: GLG Expert Contributor

Analysis of:U.S. reviews osteoporosis drugs' effect on heart | www.reuters.com

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 taking further in-depth review for the entire class of drugs, which hopefully will either validate the findings or reject it, thereby making the report of side-effects arising from the use of bisphosphonates more transparent.

Fracture Reductions Save Grandma!

September 27, 2007

Analysis by: GLG Expert Contributor

Analysis of:First osteoporosis study in patients with hip fracture finds once-yearly Aclasta(R)-Reclast(R) prevents additional fractures and improves survival | www.pipelinereview.com

-Decrease Mortality -Decrease Medical Costs -

Needs to be compared to EVISTA.

September 25, 2007

Analysis by: GLG Expert Contributor

Analysis of:Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis | www.pipelinereview.com

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?

Once a month Actonel

September 24, 2007

Analysis by: GLG Expert Contributor

Analysis of:New Phase III Data Presented For Once Monthly Dosing Regimen Of Risedronate To Treat Postmenopausal Osteoporosis | www.medicalnewstoday.com

This is approvable if the safety profile is beneficial.

Wyeth's Bazedoxifene in osteoporosis

September 24, 2007

Analysis by: GLG Expert Contributor

Analysis of:Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis | www.pipelinereview.com

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

The implact osteoclast inhibitors on osteonecrosis

September 24, 2007

Analysis by: GLG Expert Contributor

Analysis of:First osteoporosis study in patients with hip fracture finds once-yearly Aclasta(R)-Reclast(R) prevents additional fractures and improves survival | www.pipelinereview.com

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 which has mostly been observed in patients taking intravenous bisphosphonates for the treatment of certain types of cancer (multiple myeloma, breast cancer and other cancers with osseous metastases) and bone disorders such as Paget’s disease of bone. The possibility of severe oral osteonecrosis can occur an the relationship with Aclasta(R)-Reclast(R) should be analyzed.

Risedronate (Actonel) Trial Likely to Promote a Monthly Regimen

September 21, 2007

Analysis by: GLG Expert Contributor

Analysis of:New Phase III Data Presented For Once Monthly Dosing Regimen Of Risedronate To Treat Postmenopausal Osteoporosis | www.medicalnewstoday.com

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 benefit, but non-inferiority - it's a true head-to-head design. Second, the measured end-point is bone mineral density (BMD) of the lumbar spine, and not a clinical outcome (for example, fractures): this makes the study both easier to measure and complete, because clinical events are not being measured, just a diagnostic test value. However, this study will not be able to make conclusions about Actonel as compared to other osteoporosis treatments, or even to placebo: it can only compare Actonel to itself in different dosing protocols. The study appears to be designed in a way that will endorse a monthly risedronate regimen as equivalent to a daily regimen, as the 12 mo. BMD data is non-inferior.

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