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®

PHASE4CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Paget's Disease of the BoneHypocalcemia
Interventions
DRUG

Reclast (ZOL446, zoledronic acid)

"5 mg i.v. annually (real-life, physician prescribed)"

DIETARY_SUPPLEMENT

Calcium

1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)

DIETARY_SUPPLEMENT

Vitamin D

800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration

Trial Locations (9)

30501

Novartis Investigative Site, Gainesville

48236

Novartis Investigative Site, Detroit

75216

Novartis Investigative Site, Dallas

76708

Novartis Investigative Site, Waco

85012

Novartis Investigative Site, Phoenix

85723-0001

Novartis Investigative Site, Tucson

13210-2306

Novartis Investigative Site, Syracuse

02908

Novartis Investigative Site, Providence

53705-3611

Novartis Investigative Site, Madison

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY