Novartis Pharmaceuticals Corp (EAST HANOVER, New Jersey) reported that the US FDA has broadened the US indication for once-yearly Reclast^® (zoledronic acid) injection 5 mg for postmenopausal osteoporosis to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture. No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture, and few patients currently receive osteoporosis treatment following hip fracture despite high risk of morbidity and mortality.

The FDA decision is based on safety and efficacy data from the Recurrent Fracture Trial, the first large-scale clinical trial of its kind, which involved >2100 men and osteoporotic women aged ≥50 who had experienced a hip fracture. Results showed that compared with placebo, the drug increased bone mineral density and reduced the risk of new clinical fractures by 35%. The risk of new spine fractures was reduced by 46% and new nonspine fractures (eg, hip, wrist, and rib) by 27%. The incidence of all-cause mortality was 9.6% in the treatment group versus 13.3% in the placebo group. The reduction in mortality is multifactorial and the groups were not randomized for risk of mortality at entry into the study.

Reclast is approved in the US and EU (under the trade name Aclasta^®) to reduce the risk of fractures in all key areas of the body typically affected by postmenopausal osteoporosis, including hip, spine, and nonspine. With a single treatment, along with daily calcium and vitamin D supplements, a patient can receive a full year's fracture protection against the consequences of osteoporosis.

Reclast/Aclasta is already approved in more than 50 countries for the treatment of postmenopausal osteoporosis and in more than 70 countries for the treatment of Paget's disease of bone, the second most common metabolic bone disorder. The most common adverse events of Reclast are transient postdose symptoms such as fever and muscle pain, which occurred within the first 3 days following administration of the drug, and which resolved within 3 days. The incidence of postdose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly after the 15-minute infusion.

The active ingredient zoledronic acid in Reclast is also marketed as Zometa^® injection 4 mg and is used in certain oncology indications.