Dr. Susan Bukata and Dr. J. Edward Puzas, at the University of Rochester Medical Center New York,recently found that Forteo, a genetically engineered fragment of human parathyroid hormone, can be used to speed fracture healing and reduce intense pain from pelvic and other non-healing fractures.
In February 2009, the Orthopedic Research Society, at Rochester, revealed the results of the 145 patients enrolled in their program. The patients all had non-healed fractures that persisted for 6 months or longer. When Forteo was administered, 93 percent of the group showed significant healing and almost complete elimination of pain due to their 12 week treatment with Forteo.
Dr. Bukata's and Puzas' patients had painful non-healing pelvic fractures, and as a result were confined to wheelchairs unable to perform simple daily living tasks, like walking, dressing and bathing. After weeks of Forteo use, these patients showed callus formation, and cessation of micromotion - movement of the broken bones - that causes incredible pain, and new bone growth since Forteo stimulated the bodys' own stem cell mechanism that causes faster healing and bone growth at the fracture site.
As a result of this study the National Institute of Health established a clinical trial in Rochester, headed by principle investigator Dr. J. Edward Puzas, Ph.D. to establish the benefits of Forteo in slow healing fracture patients. Funding will be provided by the National Institute of Health and Eli Lily will be supplying the drug.
The impetus for this study started in Dr. Bukata's clinic where patients with painful spine, and pelvic fractures were treated with Forteo with amazing results. The doctor noticed that after her patients started Forteo, their fracture healed and pain relief occurred in half the time it normally would if not treated with the hormone.
Forteo turns on the bodys' own stem cell mechanism and speeds healing in just 12 weeks. Normally patients suffered for many months before they healed or experienced any pain relief without Forteo.
Forteo (Teriparatide), manufactured by Eli Lily has been on the market since 2002 for the treatment of osteoporosis. Forteo is a daily sub cutaneous injection given by the patient in the thigh or stomach to increase the activation of osteoblasts, the cells that build new bone.
Why are pelvis fractures so painful?
Below is an X-ray that shows a broken pelvis. The area between the broken bones is seen as a dark space in the center of the horizontal bone that runs between both hips. When a patient has this type of fracture, any type of bodily movement, causes micromotion of the bone which is intensely painful. Since this type of fracture can't be splinted or braced, there is no way to stabilize the bone and prevent this movement. Once the bone begins to heal, a callus forms around the bone; this callus prevents the bones from moving and eliminates the debilitating pain caused by the bones micromotion.
Image courtesy of: Imperial College London
How does Forteo work to heal these fractures?
In this study Doctor's realized that Forteo had the ability to turn on the bodys' own stem cell mechanism which in turn rapidly causes new bone growth by osteoblast stimulation. With this increase in osteoblast activity, the bone responds by creating callus formation-new bone-at either ends of the broken bones making it a great alternative to surgical repair with internal fixation. According to Dr. Puzas, "Teriparatide significantly speeds up fracture healing by changing the behavior and number of the cartilage and the bone stem cells involved in the process."
What are the risks of pelvic fractures?
Patients with these types of fracture suffer greatly with extremely limited movement and pain, so many end up in nursing homes where they need full time care. Most people don't realize that pelvic fractures are just as incapacitating and dangerous as hip fractures, with similar statistics on the numbers of individuals who suffer greatly reduced quality of life and fracture-related deaths with each of these types of fractures.
What are the benefits of this treatment?
Non-healing fractures can be treated in a very short time, affording the patient the ability to walk again in a much shorter time, and live an independent life.
If these patients see this tremendous increase in fracture healing and pain reduction, the possibility of having to go to a nursing home drops dramatically and the need for nursing home care may be eliminated.
The cost of the treatment with Forteo is expensive, but still much less than the cost that would incur if the patient had to have surgery or needed the assistance of a nursing home; also their quality of life is dramatically improved.
The results seen so far in this study are extremely encouraging, which is prompting other Doctors to use Forteo, to help their patients with various kinds of slow-healing fractures.
This study is recruiting post-menopausal women and men over the age of 50 who come to the Strong Memorial Hospital, in New York, with "low-energy pelvic fractures." One group will get Forteo and the other a placebo. The groups will be followed for 16 weeks to access their progress, using various testing modalities.