Archive for the ‘Medications’ Category
A reader has asked about bone cancer and Forteo.
Osteosarcoma is a rare bone cancer. Lilly has endowed a 15-year independent study (suggested by the FDA) of all Osteosarcoma patients in Cancer Registries, looking for individuals who have taken Forteo. The halfway point results from June 2004 through Sept 2011 were published in JBMR in Dec 2012. Of the 1448 persons who had Osteosarcoma during that time period, not one had taken Forteo.
The “black box” warning on the Forteo (Teriparatide) label refers to studies of rats, not humans. These rats very commonly get osteosarcoma without any medication. The rats were given doses 3 to 20 times the human dose for the equivalent of 70 human years. Rats’ bones never stop growing. Growing bones are particularly vulnerable to osteosarcoma. Humans are different from rats.
How do you know when an Antiresorptive medication is best? First, the situation needs to be beyond the capability to Take Control Naturally with Calcium Citrate and Vitamin D3 alone. A dropping Bone Mineral Density (BMD) or a worsening Vertebral Fracture Assessment (VFA) despite adequate Calcium and Vit D3 indicates the need for medication.
Second, the bone needs to be Good Enough that preserving it at current levels will prevent fractures. Good enough means no Fragility Fractures and no Vertebral Compression Fractures detectable on the VFA by DXA machine or by lateral spine x-ray.
Studies of combinations of osteoporosis medications expanded at the American Society for Bone and Mineral Research (ASBMR) 2012. Previous meetings featured alternating the anabolic, Teriparatide (Forteo) with a Bisphosphonate Antiresorptive, usually Alendronate (generic Fosamax), and, more recently, simultaneous Alendronate and Forteo. This time we heard about the first study of Denosumab (Prolia) combined with Forteo. [Disclosure: I am on the Orthopedic Advisory Board for Prolia, and Speakers Bureau for Forteo]
The Bone Mineral Density (BMD) increase at one year was much better for the combination than for either drug alone. This is the same effect we have seen with previous combinations, but higher BMD numbers. This study had small numbers of patients (<200), and a short period of time (<2 years). It is not clear, whether the greater BMD of this combination is of any significance, and how well it will hold up over time. Also, BMD is not the whole story.