In the registration study of calcitonin, we did not convincingly demonstrate fracture prevention. Novartis, the maker decided not to do a bigger study, probably because it lacked confidence in the drug’s efficacy as a treatment for osteoporosis. I do not recommend this drug for treatment of osteoporosis. It is not indicated for prevention. In my opinion, there is no reason to use this drug.
US FDA Indication from the Miacalcin Label
Treatment of Postmenopausal Osteoporosis
Miacalcin Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Miacalcin Nasal Spray should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Nasal Adverse Reactions from the Miacalcin Label
Adverse reactions related to the nose including rhinitis and epistaxis have been reported. Development of mucosal alterations may occur. Therefore, periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessels are recommended prior to start of treatment with Miacalcin Nasal Spray, periodically during the course of therapy, and at any time nasal symptoms occur.
Miacalcin Nasal Spray should be discontinued if severe ulceration of the nasal mucosa occurs, as indicated by ulcers greater than 1.5 mm in diameter or penetrating below the mucosa, or those associated with heavy bleeding. Although smaller ulcers often heal without withdrawal of Miacalcin Nasal Spray, medication should be discontinued temporarily until healing occurs.
Risk of Malignancy from the Miacalcin Label
In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The benefits for the individual patient should be carefully considered against possible risks.