Does Calcitonin-salmon work?
Partly: one 5-year trial of 1,255 women, with gaps and a small cancer warning.
The osteoporosis use rests mainly on the PROOF trial, a five-year randomized placebo-controlled study of 1,255 postmenopausal women in which only the middle of three nasal doses reduced new vertebral fractures, with no clear dose response. The current injection label states that fracture-reduction efficacy has not been demonstrated, and a 21-trial meta-analysis cited on the label found more malignancies with calcitonin than placebo. That combination keeps the grade at B despite approval. 35
The PROOF study randomized 1,255 postmenopausal women with established osteoporosis. They got one of three nasal-spray doses or placebo for five years. Everyone also took calcium and vitamin D. The middle dose cut the risk of new spine fractures by 33% compared with placebo. The lower and higher doses did not reach significance. The authors could not fully explain this pattern. 3
The injection label sums up a meta-analysis of 21 randomized controlled trials. They tested nasal and investigational oral calcitonin-salmon. Cancers were reported in 4.1% of treated patients and 2.9% of placebo patients. Because of this, the label asks prescribers to re-check from time to time whether the patient still needs the drug. 5
Evidence checklist
- Randomised controlled trial PROOF, 5-year placebo-controlled trial
- Human study over 100 people PROOF, 1,255 postmenopausal women
- More than one research group Trials plus EMA and FDA reviews
- Clinical outcomes, not surrogate markers Vertebral fractures; only middle dose worked
- Human safety data beyond case reports 21-trial meta-analysis found more cancers
Read the full Calcitonin-salmon page
More on Calcitonin-salmon
Citations
- Drugs.com AHFS monograph: calcitonin-salmon drugs.com
- DrugBank DB00017: salmon calcitonin go.drugbank.com
- Chesnut 2000, Am J Med: randomized trial of nasal spray salmon calcitonin in postmenopausal osteoporosis (PROOF) doi.org
- EMA referral, 2012: calcitonin-containing medicines ema.europa.eu
- Miacalcin injection prescribing information drugs.com
- Miacalcin nasal spray prescribing information drugs.com
Reference information only, not medical advice. Drawn from the Calcitonin-salmon article, fact-checked against the cited sources. No dosing anywhere on this site.