Phase 4 N=80 Treatment

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®

Paget's Disease of the Bone · Hypocalcemia

Bottom Line

View on ClinicalTrials.gov: NCT00668200 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Mar 2014

Primary outcome: Primary: Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid. — 1.3; 0.0 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Reclast (ZOL446, zoledronic acid) (Drug); Calcium (Dietary_supplement); Vitamin D (Dietary_supplement)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.	1.3; 0.0	—
SECONDARY Change From Baseline in Serum Calcium (mmol/L) - Safety Population	-0.024; 0.04	—
SECONDARY Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)	1.3; 3; 3.2; 0; 2.7; 1.4	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

As per currently approved Reclast® Package Insert:

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00668200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.