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• 2008

  28 August 2008: Announcement no. 2, 2008: Zealand Pharma today announced that Dr. David H...

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  Zealand's Pipeline comprises 1 compound in phase III, 2 compounds in phase II, 3 compounds ...

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Osteoporosis

The skeleton is a metabolically active organ that undergoes continuous remodeling throughout life. Normally, bone resorption is equally balanced with bone formation to maintain skeletal strength. Osteoporosis occurs when bone resorption takes place faster than bone formation, and currently affects up to one in two women and one in five men over the age of 50 years. Incidence is on the increase, largely because of a growing ageing population.

Fracture of the hip is frequently a catastrophic event in the elderly, often resulting in death within a year and of the survivors, few regain pre-fracture quality of life. Although less appreciated, fractures of the spine result in significant morbidity and are associated with increased mortality compared with individuals without a fracture.

Worldwide there are approximately 65 million people affected by osteoporosis today. Osteoporosis is an under-diagnosed disease where only 25% is currently diagnosed and even fewer are treated. Over the next 10 years, the number is expected to increase 2-5 folds. Expected increased awareness of osteoporosis - both among physicians and the public - improved diagnosis, and new therapeutic treatments that are acceptable and attractive to patients, will result in better quality of life and improved compliance.

Current treatment and unmet need
The Osteoporosis treatment options are divided into two paradigms:

• Prophylactic treatment with anti-resorptive agents, where the current bone mass is preserved and patients profit from a delay in progression of the disease. Anti-resorptive agents are most effective when the condition is diagnosed at an early stage before a significant bone loss, but once patients reach a severe stage these products are often inadequate.
• Anabolic treatment, where bone is rebuilt to avoid fractures and to maintain good quality of life.

Severely affected patients may be prescribed the strong anabolic therapy of Parathyroid hormone (PTH) to quickly build up bone density.  PTH stimulates the formation of new bone by increasing the number and action of bone-forming cells, called osteoblasts. PTH strengthens and rebuilds bones and prevents debilitating bone fractures.

Recombinant human parathyroid hormone (1-34), hPTH(1-34) was approved by the US FDA for the treatment of postmenopausal osteoporosis and male osteoporosis secondary to hypogonadism in November 2002. This is the first osteoporosis treatment that leads to the formation of new bone (i.e., anabolic agent) with architecture similar to normal bone. However, treatment with either PTH(1-34) or full length PTH(1-84) produces hypercalcemia, which in turn is associated with nausea.

 

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