Study to Evaluate the Safety and Efficacy of BA058 for Prevention of Fracture in Postmenopausal Women

Osteoporosis remains one of the most frequent and serious conditions facing postmenopausal women. It is defined as a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture (Lippuner, 2012, p.1). Ageing population contributes to the burden of osteoporosis on the developed world, increasing the society's medical and socioeconomic costs. Because the risks, incidence, and prevalence of osteoporosis grow exponentially with age, its costs are likely to exceed those of other chronic diseases, including cardiovascular events (Lippuner, 2012).

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The goal of osteoporosis treatment is to prevent fractures. Contemporary medicine uses a diversity of pharmaceutical, surgical, and preventive methodologies to decrease bone resorption or facilitate bone formation (Lippuner, 2012). Bisphosphonates exemplify the centerpiece of modern osteoporosis treatment: they were found to inhibit bone resorption and increase bone mass formation in postmenopausal women with confirmed osteoporosis (Lippuner, 2012). However, regardless of the mode of administration (orally or intravenously), bisphosphonates were shown to expose elderly patients to considerable health risks, ranging from esophageal irritation to acute-phase reactions (Lippuner, 2012). Reduced renal function is one of the chief contraindications for the use of biophosphonates in postmenopausal women (Lippuner, 2012).

Earlier studies explored the relative efficacy of non-hormonal approaches to fracture prevention in postmenopausal women with osteoporosis. Recently, the effects of Denosumab on fracture prevention in postmenopausal women with confirmed osteoporosis have been tested (Cummings et al., 2009). Denosumab is a monoclonal antibody to the nuclear factor-kB ligand, which inhibits the development of osteoclasts, reduces bone resorption and increases bone density (Cummings et al., 2009). It has proved to be relatively effective in treating osteoporosis and reducing the risks of vertebral, nonvertebral, and hip fractures in postmenopausal women (Cummings et al., 2009).

The efficacy of risedronate, a new bisphosphonate, was tested in terms of reducing the risks of vertebral and nonvertebral fractures in postmenopausal women (Harris et al., 1999). In a randomized, double-blind clinical trial involving 2458 ambulatory women with the history of fracture, risedronate was proved to be effective for treating osteoporosis in postmenopausal women (Harris et al., 1999). However, the risks of using bisphosphonates in elderly patients should not be disregarded (Lippuner, 2012).

Lasofoxifene was proposed as a new method of treating osteoporosis and preventing fractures in postmenopausal women. Cummings et al. (2010) conducted a randomized trial involving 8556 postmenopausal women with low bone density to test the effects of lasofoxifene on the risks of fractures, breast cancer, strokes and coronary heart disease. Cummings et al. (2010) reported the benefits of lasofoxifene as a means to reduce the risks of bone fractures in postmenopausal women, but no other studies were conducted to confirm the initial results. Anecdotal evidence emerges that soy products can help prevent fractures in postmenopausal women, but soy food consumption alone will never suffice to reduce the scope of osteoporosis in the public health system (Zhang et al., 2005). At the same time, the mechanisms by which some women develop increased risks of bone fractures after the menopause are yet to be understood (Garnero et al., 2000).

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Recent advancements in the professional knowledge of bone pathophysiology have led to the development of new experimental preparations with a strong therapeutic potential. BA058 is a synthetic alternative to hPTHrP, a novel analog that holds a promise to reduce the risks of bone fractures in postmenopausal women. The physiologic role of hPTHrP, a parathyroid hormone (PTH)-related peptide, has been at the center of major medical developments since the 1980s. hPTHrP was shown to participate in normal bone biology, through normal endochondral bone formation and controlled cartilage proliferation (Mundy & Edwards, 2008). BA058 exemplifies a postmodern pharmaceutical analog of hPTHrP (1-34), or teriparatide, an effective bone anabolic substance with an exclusive efficacy profile (Lippuner, 2012). While PTHrP facilitates tooth eruption followed by bone resorption, its continuous administration can potentially result in bon formation (Lippuner, 2012).

This interventional randomized double-blind placebo-controlled comparative phase 3 study is designed to evaluate the efficacy and safety of BA058 as a method of preventing fracture in ambulatory postmenopausal women with confirmed severe osteoporosis and high risks of fracture. The results of the placebo-controlled Phase 2 study showed that BA058 80 mcg led to bone mass gains and was well tolerated by postmenopausal women (Hattersley et al., 2012). BA058 is available in the dose of 80 mcg, and we plan to administer it subcutaneously, on a daily basis. The active comparator to be used is teriparatide, also titled Forteo or Forsteo. The comparator is available as 20 mcg injections to be administered subcutaneously, on a daily basis. We plan to measure the outcomes of the trial, by estimating new vertebral fractures through X-ray. We will also evaluate bone mineral density of hip, lumbar spine, ad femoral neck, non-vertebral fractures, and the number and frequency of hypercalcemic events. All results in the BA058 group will be compared to the outcome measures in the placebo group. The study involves only healthy postmenopausal women aged between 50 and 85 years, with confirmed severe osteoporosis. Only women with bone mineral density ?2.5 and >-5.0 are allowed to participate. We plan to include only women with normal laboratory tests, including the normal range for PTH (1-34) and alkaline phosphatase. Women with the history of thyroid, parathyroid, and similar disorders, including adrenal abnormalities, will be excluded from the sample. BA058 is currently unavailable as a drug and has not been approved officially.

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