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:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00668200
First received: April 22, 2008
Last updated: February 8, 2013
Last verified: February 2013
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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: ZOL446 |
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:
Genetics Home Reference related topics:
inclusion body myopathy with early-onset Paget disease and frontotemporal dementia
juvenile Paget disease
Paget disease of bone
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Incidence of unresolved and resolved hypocalcemic events based on serum calcium measurements. [ Time Frame: at days 9 - 11 post-infusion and, if needed, day 30, compared to baseline values and to historical controls ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Identify the incidence of symptoms associated with hypocalcemia based on responses to questionnaires. [ Time Frame: at days 9 - 11 post-infusion and, if needed, day 30, compared to baseline ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Single arm
Open label, single arm treatment study
|
Drug: ZOL446
5mg i.v. annually ("real-life, physican prescribed")
Other Name: zoledronic acid, Aclasta®
|
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 |
| Last Updated: | February 8, 2013 |
| 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 Hypocalcemia Osteitis Deformans Musculoskeletal Diseases Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance Zoledronic acid |
Vitamin D Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013