Annual dose of drug may help fight osteoporosis

[Guest guest]

Annual dose of drug may help fight osteoporosis

By Doug Macron

NEW YORK, Feb 27 (Reuters Health) - An annual infusion of a cancer drug

can boost bone density just as well as medications that must be taken by

mouth every day, according to a new report.

The findings suggest that the drug could be an effective treatment for

the bone-thinning disease osteoporosis, the international team of

researchers conclude in the February 28th issue of The New England

Journal of Medicine.

The drug, Zometa (zoledronic acid), was first approved to treat

excessive amounts of calcium in the blood in cancer patients, and last

week the US Food and Drug Administration extended this approval to

treatment of tumors that have spread to bone.

Zometa belongs to a class of drugs called bisphosphonates, which are

used orally to treat osteoporosis. These drugs have drawbacks, the

researchers note, including gastrointestinal intolerance and poor

absorption by the gastrointestinal tract.

To investigate whether Zometa might be an effective osteoporosis

treatment--and sidestep the problems seen with oral versions of the

drug--Dr. Ian R. Reid of the University of Auckland in New Zealand and

colleagues tested the drug in 351 postmenopausal women with low bone

mineral density.

The patients received one of five different treatment regimens: 0.25

milligrams (mg), 0.5 mg or 1 mg given every 3 months; a 2 mg dose every

6 months; or a single 4 mg dose; or an inactive placebo. The study

lasted one year.

According to the report, researchers observed similar increases in bone

mineral density among all Zometa-treated patients, which were 5% higher

than increases seen in the placebo-treated patients.

And the increases in bone mineral density among Zometa-treated patients

were comparable to increases experienced with daily doses of three

osteoporosis drugs given orally: Actonel, Fosamax and Aredia.

While the rates of adverse events were similar among all Zometa-treated

patients, such events were significantly less common among patients

receiving placebo. Among those treated with Zometa, the most common side

effects were musculoskeletal pain, nausea and fever, most of which were

reported as mild.

The maker of Zometa, Swiss drug giant Novartis, helped fund the study.

" Osteoporosis has been regarded as requiring daily therapy, and

maintaining compliance with daily regimens for a predominantly

asymptomatic condition has been a major problem, " the study's

investigators write. " Administration of treatment at intervals of 6 to

12 months or more is likely to be much more acceptable to patients and

could reduce costs. "

" If (Zometa) prevents fractures as well as the available treatments,

then the idea of having an injection once a year...is vastly more

attractive to all of us who might be patients than the idea of taking

tablets every day...and getting problems with indigestion and all those

other difficulties that arise through regular use of osteoporosis

treatments, " Reid, the study's lead investigator, told Reuters Health.

However, Reid noted that the trial was a small one, and that data from

larger studies must be evaluated before any solid conclusions on

Zometa's role in combating fractures can be drawn.

To that end, studies are under way to evaluate the effect of a single,

annual 5 mg dose of Zometa for treating various bone-thinning

conditions, , vice president of clinical research and

development at Novartis, said in a telephone interview with Reuters

Health.

The first trial includes over 8,000 men and postmenopausal women with

osteoporosis, and is examining the effect of Zometa in preventing

vertebral and hip fractures. The second study includes about 3,000 men

and postmenopausal women who have broken one hip, and is evaluating the

role of the drug in preventing fractures in either hip.

said that Novartis is also conducting a number of smaller

studies, with a total of less than 1,000 patients, examining the single

dose of Zometa in various conditions including Paget's disease.

said that the company expects to begin filing applications

for US approval of Zometa for these indications, starting with the

prevention of fractures in osteoporosis patients, in 2005.

SOURCE: The New England Journal of Medicine 2002;346:653-661.