The treatment was shown to reduce the frequency of bone fracture across the most common osteoporotic fracture sites. Reclast was highly effective in reducing the incidence of bone fracture in women with postmenopausal osteoporosis across hip, spine and non-spine with sustained effect over three years.
Further data demonstrated that postmenopausal osteoporosis patients currently taking oral alendronate can be directly switched to Reclast and maintain beneficial bone effects for a full 12 months after a single dose.
The trial showed that patients treated with Reclast experienced a 70% risk reduction in new spine fractures and a 40% risk reduction in hip fractures over three years compared to placebo. This met the study’s two primary endpoints. Additionally, the study met all secondary endpoints including risk reduction in clinical spine fractures and non-spine fractures.
The most common adverse events associated with Reclast were the following post-dose symptoms: fever, muscle pain, flu-like symptoms, headache, and bone pain, the majority of which occurred within the first three days following Reclast administration. The majority of these symptoms resolved within the first three days of the event onset. The incidence decreased markedly with subsequent doses of Reclast. Analysis of key safety parameters, including kidney and jaw safety, found Reclast to be comparable to placebo.
“The efficacy and safety data show that for the first time women may have the option of a once yearly treatment for osteoporosis,” stated Dr Dennis Black, the study steering committee chair from University of California. “The results show that Reclast effectively protects women against fractures including those of the hip, which can be devastating.”
Reclast is the only once-yearly bisphosphonate treatment being studied for the treatment of osteoporosis.