TUESDAY, May 14 (HealthDay News) -- A new combination drug
therapy for osteoporosis appears to increase bone density more
effectively than any treatment now on the market, according to the
results of a small clinical trial.
Researchers found that postmenopausal women experienced
significant amounts of bone growth by taking a bone-building drug
called teriparatide with denosumab, a targeted therapy drug used to
stop bone loss.
"A combination of these two medications increased bone density more than either does on its own, and it is more effective than any currently approved therapy," said study author Dr. Benjamin Leder, who is with the endocrine unit at Massachusetts General Hospital in Boston.
The 12-month study, published online May 15 in
The Lancet, was funded in part by the drugs' makers, Eli
Lilly and Amgen. It involved 94 postmenopausal women being treated
for osteoporosis, a bone-thinning disorder common in old age that
makes bones more likely to break.
Researchers divided the group into thirds, with one third
receiving a combination therapy of teriparatide (Forteo) and
denosumab (Prolia), and the rest taking one medication or the
Those treated with both drugs enjoyed significantly better
results than those receiving just one. For example, bone density
measured at the lumbar spine increased 6.2 percent with
teriparatide alone and 5.5 percent with denosumab alone, but
combination treatment resulted in a 9.1 percent increase. Bone
density at the hip increased 4.9 percent with the combination
treatment versus 2.5 percent with denosumab and 0.7 percent with
Bones are in constant flux, with one set of cells forming new
bone while other cells break down bone through a process called
resorption. After women go through menopause, resorption begins to
outpace the formation of new bone, leading to bone thinning and an
increased risk of fractures.
Several types of drugs are approved to tackle the problem.
Medications such as teriparatide stimulate new bone growth, and
drugs such as denosumab reduce bone resorption, but none do both at
the same time.
The combination used in this study works because the two drugs
act in concert to overcome each other's shortcomings, Leder
"Whereas teriparatide increases bone formation, it also increases bone resorption," Leder said. "Denosumab completely blocks the ability of teriparatide to increase bone resorption, but does not block its ability to increase bone formation."
Dr. Felicia Cosman, senior clinical director for the National
Osteoporosis Foundation, said the findings look very promising.
"I think it is time to reconsider the whole issue of combination therapy, based on this study and others, particularly for people with extremely high fracture risk," Cosman said.
However, she noted that it remains to be seen whether the
effectiveness of the combination therapy will hold up beyond the
first year, a concern shared by Dr. Richard Bockman, chief of
endocrinology at Hospital for Special Surgery in New York City.
"This is an interim report, and the data are what they are. I think you have to see the two-year data," Bockman said. "You don't see the full benefit with regards to bone benefit at the hip in the first 12 months. You do see the change at the spine."
And another expert pointed out another possible caveat.
There's some question about whether the new bone grown with this
therapy will be better able to resist fractures, said Dr. Joseph
Lane, chief of metabolic bone disease service at Hospital for
Special Surgery and a professor of orthopedic surgery at Weill
Cornell Medical College in New York City.
"It seems to work," Lane said. "This is an important step in the right direction. It proves you can make more bone."
But Lane wonders about the quality of that bone. Only data on
fracture healing can address that question, he noted.
The study authors acknowledged that additional research is
needed before the combination treatment should be used in clinical
Leder noted that both drugs are expensive, which makes the
therapy potentially most cost-effective for patients in dire
"Because we don't know what the effect is on fractures, it's a hard calculation to make," he said. "If it prevents x number of fractures, then it could be cost- effective."
The National Osteoporosis Foundation has more about
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