Calcitonin
Main evidence: Human clinical trials. Updated 2026-10-28.
What research and users report, not a recommendation or medical advice. Many of these products are not approved for human use. Ask your doctor. Packs report what sources say, each with its evidence label. A claim labelled community, educator, manufacturer or animal has not been validated in humans.
Summary
This information-only pack separates Australian calcitonin injection labeling from historical nasal-spray osteoporosis research and summarizes the associated safety warning.
Safety and cautions
Safety statements are source-specific and should not be generalized across products, formulations or routes.
Australian legal status
The TGA register listed active Australian entries for an injection and a nasal-spray presentation on 2026-10-28. The retrieved current Australian Product Information is for the injection and restricts its indications to active Paget's disease in the stated circumstances and hypercalcaemia. Historical overseas nasal-spray evidence is kept separate and should not be read as an Australian indication.
What the sources say
- In the five-year PROOF randomized trial of 1,255 postmenopausal women with established osteoporosis, the 200-IU daily nasal-spray group had fewer new vertebral fractures than placebo (51 of 287 versus 70 of 270; relative risk 0.67). Only 511 participants completed five years, and the result concerns an historical nasal-spray trial, not the currently retrieved Australian injection product information or proof of benefit for other calcitonin routes. (Human clinical trials; Chesnut CH et al., PROOF randomized trial of salmon calcitonin nasal spray, PubMed record (issue September 2000; accessed 2026-10-28)., 2026-10-28)
- The current Australian Miacalcic injection product information lists active Paget's disease when alternatives are unsuitable or ineffective, and hypercalcaemia, as its therapeutic indications. It does not list osteoporosis as an indication for the injection product. (Manufacturer information; Chiesi Australia, Australian Product Information: Miacalcic (calcitonin salmon), version 3, revision 2026-03-11., 2026-03-11)
- The Australian injection product information says long-term calcitonin use was associated in meta-analyses with a small statistically significant increase in malignancy incidence; it notes limitations in those analyses and advises weighing individual benefit against possible risk. (Manufacturer information; Chiesi Australia, Australian Product Information: Miacalcic (calcitonin salmon), version 3, revision 2026-03-11., 2026-03-11)
- The Australian product information warns about rare serious hypersensitivity, including anaphylaxis, and reports nausea, diarrhoea, abdominal pain, flushing, dizziness and fatigue. It also warns of the long-term malignancy signal described in the Claims section and recommends regular reassessment and limiting exposure to the shortest possible period. (Manufacturer information; Chiesi Australia, Australian Product Information: Miacalcic (calcitonin salmon), version 3, revision 2026-03-11., 2026-03-11)
- The TGA ARTG record lists MIACALCIC calcitonin-salmon injection (ARTG 13364) with licence status A when checked on 2026-10-28. (Educator material (not peer reviewed); TGA, ARTG entry 13364: MIACALCIC calcitonin-salmon injection (active status checked 2026-10-28)., 2026-10-28)
Sources
- Chesnut CH et al., PROOF randomized trial of salmon calcitonin nasal spray, PubMed record (issue September 2000; accessed 2026-10-28). (2026-10-28)
- Chiesi Australia, Australian Product Information: Miacalcic (calcitonin salmon), version 3, revision 2026-03-11. (2026-03-11)
- TGA, ARTG entry 13364: MIACALCIC calcitonin-salmon injection (active status checked 2026-10-28). (2026-10-28)
Dosing, stacking and protocol details are not published here.