10 January 2014

Antibodies against osteoporosis – a new hope for doctors

Romosozumab, an experimental drug for the treatment of osteoporosis, stimulates bone repair by blocking signals that inhibit bone formation and strengthens the skeleton, preventing fractures.

According to the founding director of the Oregon Osteoporosis Center, Dr. Michael McClung, the principle of action of most drugs for the treatment of osteoporosis is to stop the process of degradation of bone tissue. However, they do not have the ability to repair skeletal damage. Therefore, the appearance of romosozumab is a turning point in the history of osteoporosis treatment.

The active ingredient of romosozumab is antibodies that block the activity of sclerostin, a protein produced by the body to suppress the formation of new bone tissue. In the absence of sclerostin, excessive bone growth can lead to pinching of nerve endings or loss of mobility of the spine. However, this protein also prevents the restoration of bone tissue damage and the maintenance of its density in patients with osteoporosis.

Romosozumab antibodies bind sclerostin and block the signaling mechanism mediated by it, which makes it possible to form bone tissue.

419 post-menopausal women aged 55-85 participated in the phase 2 clinical trial of romosozumab. All women were diagnosed with osteopenia, manifested by a decrease in bone mass, which cannot yet be classified as osteoporosis. All participants were randomly divided into 8 groups. Five groups received subcutaneous injections of romosozumab for 12 months according to different protocols, the remaining groups received a placebo or one of the two currently most widely used drugs for the treatment of osteoporosis.

The results showed that the use of romosozumab in all tested dosages increases the bone mineral density of the lumbar spine. The most pronounced improvement – an increase in bone density by 11.3% – was observed with the monthly administration of the maximum dosage of the drug, which was 210 mg. In patients of the control group, this indicator decreased slightly (by 0.1%); in the group taking alendronate (Fosamax), it increased by 4.1%, and in the group taking teriparatite (Forteo) - by 7.1%. The use of romosozumab also provided a significant increase in the mineral density of the femoral tissue, including the femoral neck. The use of the experimental drug was not accompanied by serious side effects.

Experts believe that the antibody-based drug is safe, since the signals stimulating the formation of bone tissue will gradually fade as the skeleton strengthens and its ability to withstand loads improves.

For the final confirmation of the therapeutic efficacy of romosozumab, additional clinical studies are necessary, and its appearance on the pharmaceutical market will not occur earlier than in a few years. However, experts express great enthusiasm about this drug.

Article by Michael R. McClung et al. Romosozumab in Postmenopausal Women with Low Bone Mineral Density is published in the New England Journal of Medicine.

Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of NewsmaxHealth:
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