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OpenTrials
Completed

NCT Number: NCT00668200

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 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.

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Key information

Conditions

Paget's Disease of the Bone Bone Diseases Calcium Metabolism Disorders Hypocalcemia Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteitis Deformans Water-Electrolyte Imbalance

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • As per currently approved Reclast® Package Insert:

Treatment and study plan

Reclast (ZOL446, zoledronic acid)

Drug

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

Other names: Reclast, ZOL446

Calcium

Dietary Supplement

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

Vitamin D

Dietary Supplement

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

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Change From Baseline in Serum Calcium (mmol/L) - Safety Population

    Time frame: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)

    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.

  2. 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 (days 9 - 11 post-infusion) or visit 3 (day 30)

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2008
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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