Nasal spray helps treat postmenopausal osteoporosis

September 12, 2005

Osteoporosis is a result of a disproportionate rate of bone resorption compared with bone formation, which disrupts the structural integrity of bone. The most common type of osteoporosis occurs in postmenopausal women.

The Food & Drug Administration recently approved calcitonin-salmon nasal spray (Fortical, Upsher-Smith Laboratories) for the treatment of postmenopausal osteoporosis in women more than five years after menopause with low bone mass as compared with that of healthy premenopausal women.

"Fortical is produced by recombinant DNA technology, whereas the currently marketed calcitonin-salmon nasal spray [Miacalcin, Novartis] is a synthetic formulation," stated Tim Allen, R.Ph., White's Pharmacy in Morristown, N.J. "Unlike Miacalcin nasal spray, Fortical does not contain benzalkonium chloride, a known nasal irritant, in its formulation. Therefore, it may potentially cause less nasal irritability," he added.

The efficacy of calcitonin-salmon has been shown in clinical trials conducted in postmenopausal women for more than two years. Compared with placebo, statistically significant in-creases in lumbar vertebral bone mineral density were detected as early as six months after initiation of calcitonin-salmon therapy, with persistence for up to two years.

The development of mucosal alterations or transient nasal conditions has been reported in patients receiving calcitonin-salmon during clinical studies. The most common nasal adverse events associated with nasal calcitonin include rhinitis, epistaxis, and sinusitis. Smoking was demonstrated not to have any contributory effects on the occurrence of nasal side effects. The manufacturer advises that a nasal examination be performed prior to start of therapy with nasal calcitonin and at any time nasal complaints occur.

The package labeling warns that because calcitonin is a polypeptide, the possibility of a systemic allergic reaction exists. Prior to initiating therapy in patients with a suspected sensitivity to calcitonin, skin testing should be considered using a dilute, sterile solution of a calcitonin-salmon injectable product. The manufacturer suggests that clinicians may wish to refer patients who require skin testing to an allergist.

The recommended dose of Fortical is 1 spray (200 International Units) per day, administered intranasally, alternating nostrils daily. "Patients must be advised that Fortical is recommended in conjunction with an intake of at least 1,000 mg elemental calcium and 400 International Units of vitamin D per day to retard the ongoing bone mass loss," said Allen.

"Pharmacists should demonstrate the use of Fortical nasal spray to their patients and give them written instructions on pump assembly," emphasized Allen. "Patients should be informed that the new pump must be primed before the first use. Thereafter, it is not necessary to re-prime it before each daily use," he concluded.

The author is a clinical writer and hospital pharmacist based in New Jersey.