Rx May Improve Bone Density in Osteoporosis Patients

Postmenopausal women taking romosozumab experienced increase in bone density

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Osteoporosis decreases bone density, making bones more prone to breaks. A new medication being tested in clinical trials may help increase bone density.

The medication, called romosozumab, is thought to fight against proteins that decrease bone mass.

In a recent trial, older women who took romosozumab for a year reported improvements in bone density at the spine, hip and neck.

Additionally, the medication was tied to decreased markers of bone resorption, the process of the body absorbing bone tissue.

"Discuss bone loss with your doctor if you're growing older."

Michael McClung, MD, of the Oregon Osteoporosis Center, and Andreas Grauer, MD, of Amgen biopharmaceutical company, led this study.

Osteoporosis is a bone disease in which bones become less dense and more likely to break.

Postmenopausal women are particularly susceptible to osteoporosis.

This study tested the effects of the medication romosozumab on osteoporosis. Romosozumab has been developed by UCB Pharma and Amgen and has not yet been approved by the US Food and Drug Administration (FDA).

Dr. McClung and colleagues recruited 419 postmenopausal women between the ages of 55 and 85 who had low bone density. These participants were randomly placed in one of eight groups.

Five of the groups each tested a different dosage regimen of romosozumab by receiving injections of the medication, either every month or every three months, for a year.

Two of the groups received alendronate (brand name Fosamax), another osteoporosis medication, or teriparatide (brand name Forteo), a hormone that promotes bone growth.

The remaining 52 participants received placebo (fake medication) injections either monthly or every three months.

The researchers assessed bone density and levels of calcium at baseline and every three months. They specifically looked for changes in bone mineral density at the spine, hip, neck and forearm.

The participants' bone metabolism, or how fast bone tissue is absorbed and replaced in the body, was also measured.

After 12 months, the researchers found that the participants in the romosozumab groups had significant increases in bone density at the spine, hip and neck compared to those in the placebo groups.

The largest gains were made by the participants receiving the 210-milligram monthly dose. Over 12 months, these participants had an average increase in bone density of 11.3 percent at the spine, 4.1 percent at the hip and 3.7 percent at the neck.

These gains also outpaced those made by the patients in the alendronate and teriparatide groups.

Romosozumab was also tied to a decrease in bone resorption.

The researchers concluded that romosozumab led to increased bone mineral density, especially at monthly doses of 140 milligrams and 210 milligrams.

Some participants reported adverse events, but the rate of adverse events was similar between the placebo and romosozumab groups.

According to the authors of this study, none of the serious adverse events were considered to be treatment-related.

These researchers suggested that romosozumab be further evaluated as a treatment for osteoporosis patients.

This study was published in the New England Journal of Medicine on January 1.

The research was funded by Amgen and UCB Pharma. Several of the researchers are employed by Amgen.

Review Date: 
January 3, 2014
Last Updated:
January 5, 2014