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®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00668200
First received: April 22, 2008
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Paget's Disease of the Bone
Hypocalcemia
Drug: Reclast (ZOL446, zoledronic acid)
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post US Approval Voluntary Registry Study to Determine Incidence of Hypocalcemia Post Reclast® Treatment in Patients With Paget's Disease After Institution of Educational Strategies to Improve Adherence to Calcium and Vitamin D Supplementation

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid. [ Time Frame: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30) ] [ Designated as safety issue: Yes ]
    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. Seventy-five (75) of the 81 patients in the safety population met the criteria. Six did not meet criteria and were excluded from the analysis: 1 patient had a low serum calcium at baseline, and the other 5 patients were missing serum calcium values either at baseline or post-baseline. So it should be 75 and not 81.


Secondary Outcome Measures:
  • Change From Baseline in Serum Calcium (mmol/L) - Safety Population [ Time Frame: Baseline, Visit 2, Visit 3 ] [ Designated as safety issue: Yes ]
    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. For End of study the last post-baseline serum calcium is used.

  • Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population) [ Time Frame: End of study Visit 2 or Visit 3 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 85
Study Start Date: May 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
zoledronic acid
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.
Drug: Reclast (ZOL446, zoledronic acid)
5 mg i.v. annually ("real-life, physician prescribed")
Other Name: Reclast, ZOL446
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- As per currently approved Reclast® Package Insert:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668200

Locations
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85012
Novartis Investigative Site
Tucson, Arizona, United States, 85723-0001
United States, Georgia
Novartis Investigative Site
Gainesville, Georgia, United States, 30501
United States, Michigan
Novartis Investigative Site
Detroit, Michigan, United States, 48236
United States, New York
Novartis Investigative Site
Syracuse, New York, United States, 13210-2306
United States, Rhode Island
Novartis Investigative Site
Providence, Rhode Island, United States, 02908
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75216
Novartis Investigative Site
Waco, Texas, United States, 76708
United States, Wisconsin
Novartis Investigative Site
Madison, Wisconsin, United States, 53705-3611
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00668200     History of Changes
Other Study ID Numbers: CZOL446K2401
Study First Received: April 22, 2008
Results First Received: November 4, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Paget's
hypocalcemia
zoledronic acid
serum calcium

Additional relevant MeSH terms:
Bone Diseases
Osteitis Deformans
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Bone Density Conservation Agents
Hypocalcemia
Water-Electrolyte Imbalance
Zoledronic acid
Calcium, Dietary
Vitamin D
Ergocalciferols
Diphosphonates
Vitamins
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014