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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
5 mg i.v. annually ("real-life, physician prescribed")
1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Gainesville, Georgia, United States
Novartis Investigative Site
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium \<2.07 mmol/L at 9-11 days after the study drug infusion.
Time frame: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Change From Baseline in Serum Calcium (mmol/L) - Safety Population
Change from baseline = endpoint - baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.
Time frame: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.
Time frame: End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)
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Detroit, Michigan, United States
Novartis Investigative Site
Syracuse, New York, United States
Novartis Investigative Site
Providence, Rhode Island, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Waco, Texas, United States
Novartis Investigative Site
Madison, Wisconsin, United States