Conditions: Paget's Disease of the Bone Hypocalcemia
Keywords: Paget's hypocalcemia zoledronic acid serum calcium
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 81
Healthy volunteers: no

Brief summary:
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.

Detailed description:

Arms:
arm 1: 5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.

Interventions: intervention 1: Reclast (ZOL446, zoledronic acid) intervention 2: Calcium intervention 3: Vitamin D
Intervention descriptions: intervention 1: 5 mg i.v. annually ("real-life, physician prescribed") intervention 2: 1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation) intervention 3: 800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration

Protocol document: