Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Randomized, Double-blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observational Period
2 other identifiers
interventional
172
6 countries
34
Brief Summary
The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2001
Longer than P75 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 14, 2003
CompletedFirst Posted
Study publicly available on registry
January 15, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
May 7, 2012
CompletedMay 15, 2012
May 1, 2012
3.2 years
January 14, 2003
April 5, 2012
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Who Achieve Therapeutic Response at 6 Months.
Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
6 months
Secondary Outcomes (10)
Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
Baseline and day 28
Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
Baseline and day 10
Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10
Baseline and day 10
Time to First Therapeutic Response
182 days
Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
Baseline and day 28
- +5 more secondary outcomes
Study Arms (2)
Zoledronic Acid and Placebo to Risedronate
EXPERIMENTALParticipants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Risedronate and Placebo to Zoledronic Acid
ACTIVE COMPARATORParticipants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Interventions
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
Oral risedronate 30 mg capsules.
Oral placebo of risedronate capsules.
5 mL of sterile water one dose intravenous infusion.
Calcium and vitamin D supplements were supplied.
Eligibility Criteria
You may qualify if:
- years or older
- Serum alkaline phosphatase (SAP) 2 times upper limit normal (ULN)
- Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
- days washout calcitonin
- day washout bisphosphonate
You may not qualify if:
- Allergic reaction to bisphosphonates
- History of upper gastrointestinal disorders
- History of iritis, uveitis
- Calculated creatinine clearance \< 30 ml/min at baseline
- Evidence of vitamin D deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Novartis Investigative Site
Santa Monica, California, 90414, United States
Novartis Investigative Site
Lakewood, Colorado, 80227, United States
Novartis Investigative Site
Boca Raton, Florida, 33433, United States
Novartis Investigative Site
Miami, Florida, 33101, United States
Novartis Investigative site
Maywood, Illinois, 60153, United States
Novartis investigative site
Worcester, Massachusetts, 01601, United States
Novartis investigative site
Detroit, Michigan, 48021, United States
Novartis Investigative Site
New York, New York, 10029, United States
Novartis investigative site
Syracuse, New York, 13210, United States
Novartis investigative site
Durham, North Carolina, 27710, United States
Novartis investigative site
Medford, Oregon, 97504, United States
Novartis investigative site
Providence, Rhode Island, 02908, United States
Novartis Investigative Site
Concord, Australia
Novartis Investigative Site
Fitzroy, Australia
Novartis Investigative site
Geelong, Australia
Novartis Investigative Site
Kogarah, Australia
Novartis Investigative site
Maroochydore, Australia
Novartis Investigative site
Nedlands, Australia
Novartis Investigative Site
Calgary, Canada
Novartis Investigative Site
London, Canada
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
Ste-Foy, Canada
Novartis Investigative Site
Toronto, Canada
Novartis Investigative site
Auckland, New Zealand
Novartis Investigative Site
Christchurch, New Zealand
Novartis Investigative site
Salamanca, Spain
Novartis Investigative site
Liverpool, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Novartis Investigative site
Nottingham, United Kingdom
Novartis Investigative Site
Oxford, United Kingdom
Novartis Investigative site
Penarth, United Kingdom
Novartis investigative site
Pernarth, United Kingdom
Novartis Investigative Site
Stanmore, United Kingdom
Novartis Investigative Site
Vale of Glamorgan, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2003
First Posted
January 15, 2003
Study Start
January 1, 2001
Primary Completion
March 1, 2004
Study Completion
April 1, 2011
Last Updated
May 15, 2012
Results First Posted
May 7, 2012
Record last verified: 2012-05