Denosumab Osteoporosis and improved bone density.

Denosumab, a new Osteoporosis drug was submitted to the FDA for its approval in February 2009.

On February 18, 2009 Amgen, the company making this drug, announced that "the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer."

It is expected that the FDA will complete its review by October of 2009. Amgen has also submitted applications to market this drug for these same uses in the European Union, Canada, Switzerland, and Australia.

This new drug has in Phase III clinical Trials since 2005. The results appear very positive.

The drug is administered by injection and is taken in doses several months apart. One study of post menopausal women had some take the drug every three months while others took it at six month intervals. If this drug proveseffective, it would provide a real alternative for those who find oral medications difficult.

Here is information from some of the published studies

"Denosumab in post menopausal women with low bone mineral density."

METHODS: The efficacy and safety of subcutaneously administered denosumab were evaluated over a period of 12 months in 412 post menopausal women with low bone mineral density (T score of -1.8 to -4.0 at the lumbar spine or -1.8 to -3.5 at the proximal femur).

Subjects were randomly assigned to receive this new drug either every three months (at a dose of 6, 14, or 30 mg) or every six months (at a dose of 14, 60, 100, or 210 mg), open-label oral alendronate once weekly (at a dose of 70 mg), or placebo. The primary end point was the percentage change from baseline in bone mineral density at the lumbar spine at 12 months. Changes in bone turnover were assessed by measurement of serum and urine telopeptides and bone-specific alkaline phosphatase.

RESULTS: Denosumab treatment for 12 months resulted in an increase in bone mineral density at the lumbar spine of 3.0 to 6.7 percent (as compared with an increase of 4.6 percent with alendronate and a loss of 0.8 percent with placebo), at the total hip of 1.9 to 3.6 percent (as compared with an increase of 2.1 percent with alendronate and a loss of 0.6 percent with placebo), and at the distal third of the radius of 0.4 to 1.3 percent (as compared with decreases of 0.5 percent with alendronate and 2.0 percent with placebo). Near-maximal reductions in mean levels of serum C-telopeptide from baseline were evident three days after the administration of denosumab. The duration of the suppression of bone turnover appeared to be dose-dependent.

2. Another study was done with breast cancer patients. This was published in Clin Cancer Res. Feb. 2006. The researchers concluded that: "A single s.c. dose of denosumab given to patients with multiple myeloma or bone metastases from breast cancer was well tolerated and reduced bone resorption for at least 84 days. The decrease in bone turnover markers was similar in magnitude but more sustained than with i.v. pamidronate."

3. The journal Curr Opin Pharmacol. published a study from Switzerland in June 2006 about the same drug. This study showed that "Denosumab leads to sustained 80-90% reduction of bone resorption markers, much better that achieved with Bisphosphonates (Actonel, Boniva, Fosamax).

These studies seem very positive. Of course the main goal of any Osteopenia or Osteoporosis treatments is not jsut increasing bone density but the prevention of fractures. This goal has taken on new meaning with the recent studies that show womenwith Osteopenia are at as great a risk for fracture as those with Osteoporosis.

It will be interesting to see whether researchers find that in Denosumab's anti-fracture efficacy is as great as or better than the bisphosphonates. I will try to follow the developing researchand keep you informed since this drug could be very useful for those not wanting to use one of the bisphosphonates. Of course if the drug passes all the clinical trials and gets US FDA approval, thedrug company will get media reports out quickly.

Except of the study from Switzerland, I have no information of European Union, Australian or Canadian studiesof this new treatment. If you have scientific studies about this drug from any country outside the USA, please let me know. There is a the contact form AT THE BOTTOM of this about us page. Please use it. Denosumab Information Contact Form and let me know.

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Page revised 4.29/09