Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®

Novartis

Status and phase: Completed; Phase 4

Conditions: Paget's Disease of the Bone; Hypocalcemia

Treatments: Dietary Supplement: Calcium; Drug: Reclast (ZOL446, zoledronic acid); Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668200

CZOL446K2401

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• As per currently approved Reclast® Package Insert:

Exclusion criteria

• As per currently approved Reclast® Package Insert:

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

zoledronic acid

Other group

Description:

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.

Treatment:

Dietary Supplement: Calcium

Dietary Supplement: Vitamin D

Drug: Reclast (ZOL446, zoledronic acid)