A brief history of calcitonin

In 1994, another FDA advisory committee convened to discuss results from studies of Miacalcin nasal spray.9 By this time, measurement of bone mineral density with dual photon X-ray absorptiometry was widely available. Increases in bone mineral density, as measured by dual photon X-ray absorptiometry, were deemed by many to be a reasonable surrogate for reduced risk of osteoporotic fracture. Data from five randomised, placebo-controlled trials lasting 1-2 years and including about 550 patients were presented to the committee. The company concluded, and the committee agreed, that the drug significantly increased bone mineral density of the lumbar spine compared with placebo. Because of the favourable fracture trends from the bone mineral density studies and of the fact that the PROOF trial was continuing, the advisory committee concluded that the potential benefits of Miacalcin nasal spray outweighed the potential risks and recommended its approval. The FDA subsequently approved Miacalcin nasal spray for treatment of postmenopausal osteoporosis in women who were more than 5 years postmenopausal.10 The drug's label explicitly stated that "the evidence of efficacy [was] based on increases in spinal bone mineral density", not fracture data.