Calcitonin (Miacalcin/Fortical) - Salmon Calcitonin for Bone Disease — Bone & Mineral
FDA-approved synthetic salmon calcitonin for postmenopausal osteoporosis, Paget's disease, and hypercalcemia.
Overview
Calcitonin (salmon) is a synthetic polypeptide hormone FDA-approved for postmenopausal osteoporosis (≥5 years postmenopause), Paget's disease of bone, and hypercalcemia. It inhibits osteoclast-mediated bone resorption and promotes renal calcium excretion. PROOF study (5-year RCT, n=1,255) showed 33% reduction in vertebral fractures with intranasal 200 IU daily, though no effect on hip/non-vertebral fractures. In Paget's disease, chronic treatment reduced alkaline phosphatase ~50% with relief of bone pain and neurological symptoms. Available as intranasal spray (Miacalcin, Fortical) or injection. NOTE: FDA added boxed warning in 2015 due to slightly higher malignancy rates in meta-analysis (4.1% vs 2.9% placebo), primarily basal cell carcinoma. Generally considered second-line therapy after bisphosphonates/newer agents due to limited fracture data and cancer signal.
Indications
- Postmenopausal osteoporosis (≥5 years postmenopause) - second-line
- Paget's disease of bone
- Hypercalcemia (emergency management)
- Acute pain from osteoporotic vertebral fractures (analgesic effect)
Mechanism of Action
Osteoporosis: excessive osteoclast activity. Paget's disease: abnormal bone turnover. Hypercalcemia: elevated serum calcium
Dosing
| Compound | Dose | Frequency | Notes |
|---|---|---|---|
| Salmon calcitonin nasal spray 200 IU | 200 IU (1 spray) in one nostril | Once daily | Alternate nostrils daily; add calcium 1000 mg + vitamin D 400-800 IU daily |
| Salmon calcitonin nasal spray 200-400 IU | 200-400 IU | Once or twice weekly | Add calcium 500 mg TID + thiazide diuretic for enhanced effect |
| Salmon calcitonin injection 100 IU/mL | 100 IU SC or IM | Daily or 3x/week | For severe Paget's; may reduce to maintenance dosing once controlled |
| Salmon calcitonin injection 100 IU/mL | 4-8 IU/kg SC or IM | Every 12 hours | Emergency management; combine with IV fluids and bisphosphonates |
Evidence Grade
GRADE B
Safety & Contraindications
- ⚠️ PRESCRIPTION MEDICATION - Physician supervision required
- ⚠️ FDA BOXED WARNING (2015): Meta-analysis showed slightly higher cancer rates (4.1% vs 2.9% placebo), particularly basal cell carcinoma - risk/benefit assessment required for prolonged use
- Generally second-line therapy after bisphosphonates, denosumab, or anabolic agents
- Antibody formation: ~20% develop neutralizing antibodies (especially with long-term use); may switch to human calcitonin if resistance develops
- Nasal irritation: Common with intranasal spray (rhinitis, epistaxis, nasal ulceration)
- Flushing: 2-5% with injection form (transient, dose-related)
- Hypocalcemia: Rare but monitor calcium in patients with low baseline calcium
- Hypersensitivity reactions: Rare anaphylaxis; skin testing recommended before first injection dose
- Refrigeration required for injection; nasal spray stable at room temp after opening