Trials / Completed
CompletedNCT00668200
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®
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2008-04-29
- Last updated
- 2015-03-06
- Results posted
- 2014-03-03
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00668200. Inclusion in this directory is not an endorsement.