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MUSCULO-SKELETAL SYSTEM › DRUGS FOR TREATMENT OF BONE DISEASES › DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION › Bisphosphonates, combinations
zoledronic acid, calcium and colecalciferol, sequential
M05BB08
Forms & Strengths
- Sequential combination pack: Zoledronic acid 5 mg/100 mL IV infusion + Calcium carbonate 1000 mg / Colecalciferol (Vitamin D3) 880 IU oral tablets
Adult Dosing
- Postmenopausal osteoporosis / Osteoporosis in men: Zoledronic acid 5 mg IV infusion once yearly, administered over at least 15 minutes
- Calcium/Vitamin D supplementation: One tablet daily of calcium carbonate/colecalciferol taken on days following zoledronic acid as directed, or continuous daily supplementation as clinically indicated
Pediatric Dosing
- Safety and efficacy not established in pediatric patients; use is not recommended
Indications
- Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral, and non-vertebral fractures
- Treatment to increase bone mass in men with osteoporosis
- Prevention of postmenopausal osteoporosis
Mechanism of Action
- Zoledronic acid is a bisphosphonate that binds to bone hydroxyapatite, inhibiting osteoclast activity and bone resorption
- Calcium and colecalciferol provide essential substrate and hormonal regulation to support bone mineralization and prevent secondary hyperparathyroidism
Contraindications
- Hypersensitivity to zoledronic acid, other bisphosphonates, calcium, colecalciferol, or any excipients
- Hypocalcemia
- Severe renal impairment (CrCl < 35 mL/min or evidence of acute renal impairment)
- Abnormalities of the esophagus which delay esophageal emptying (applies to oral components)
Adverse Reactions
- Post-dose acute phase reaction (fever, myalgia, flu-like symptoms, arthralgia, headache within 3 days of infusion)
- Hypocalcemia
- Osteonecrosis of the jaw (ONJ)
- Atypical femoral fractures
- Renal function impairment
- Gastrointestinal disturbances (constipation, dyspepsia from calcium)
Drug Interactions
- Aminoglycosides: May increase risk of severe hypocalcemia and prolong hypocalcemic effect
- Loop diuretics: Increased risk of hypocalcemia
- Nephrotoxic drugs: Increased risk of renal dysfunction when coadministered with zoledronic acid
- Oral calcium/bisphosphonates: Calcium can impair absorption of certain oral medications; separate administration times
Curated Content: Needs Vetting Before Put to Clinical Use