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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00051636




Registration number
NCT00051636
Ethics application status
Date submitted
14/01/2003
Date registered
15/01/2003
Date last updated
15/05/2012

Titles & IDs
Public title
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Scientific title
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
Secondary ID [1] 0 0
ZOL446K2304
Secondary ID [2] 0 0
CZOL446H2304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paget's Disease of Bone 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic Acid
Treatment: Drugs - Risedronate
Treatment: Drugs - Placebo to Risedronate
Treatment: Drugs - Placebo to Zoledronic Acid
Treatment: Other - Calcium and Vitamin D

Experimental: Zoledronic Acid and Placebo to Risedronate - Participants 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.

Active comparator: Risedronate and Placebo to Zoledronic Acid - Participants 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.


Treatment: Drugs: Zoledronic Acid
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.

Treatment: Drugs: Risedronate
Oral risedronate 30 mg capsules.

Treatment: Drugs: Placebo to Risedronate
Oral placebo of risedronate capsules.

Treatment: Drugs: Placebo to Zoledronic Acid
5 mL of sterile water one dose intravenous infusion.

Treatment: Other: Calcium and Vitamin D
Calcium and vitamin D supplements were supplied.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Who Achieve Therapeutic Response at 6 Months.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
Timepoint [1] 0 0
Baseline and day 28
Secondary outcome [2] 0 0
Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
Timepoint [2] 0 0
Baseline and day 10
Secondary outcome [3] 0 0
Relative Change in Urine Alpha C-telopeptide (a-CTx) in ug/mmol at Day 10
Timepoint [3] 0 0
Baseline and day 10
Secondary outcome [4] 0 0
Time to First Therapeutic Response
Timepoint [4] 0 0
182 days
Secondary outcome [5] 0 0
Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
Timepoint [5] 0 0
Baseline and day 28
Secondary outcome [6] 0 0
Change in Pain Severity Score
Timepoint [6] 0 0
Baseline and day 182
Secondary outcome [7] 0 0
Change in Pain Interference Score
Timepoint [7] 0 0
Baseline and day 182
Secondary outcome [8] 0 0
Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
Timepoint [8] 0 0
8 years was the maximum
Secondary outcome [9] 0 0
Number of Participants With a Partial Disease Relapse During the Extended Observation Period
Timepoint [9] 0 0
8 years was the maximum
Secondary outcome [10] 0 0
Number of Participants With a Disease Relapse During the Extended Observation Period
Timepoint [10] 0 0
8 years was the maximum

Eligibility
Key inclusion criteria
* 30 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.).
* 90 days washout calcitonin
* 180 day washout bisphosphonate
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Other protocol-defined inclusion/exclusion criteria applied.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Concord
Recruitment hospital [2] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [3] 0 0
Novartis Investigative site - Geelong
Recruitment hospital [4] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [5] 0 0
Novartis Investigative site - Maroochydore
Recruitment hospital [6] 0 0
Novartis Investigative site - Nedlands
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Maroochydore
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Rhode Island
Country [11] 0 0
Canada
State/province [11] 0 0
Calgary
Country [12] 0 0
Canada
State/province [12] 0 0
London
Country [13] 0 0
Canada
State/province [13] 0 0
Montreal
Country [14] 0 0
Canada
State/province [14] 0 0
Ste-Foy
Country [15] 0 0
Canada
State/province [15] 0 0
Toronto
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
New Zealand
State/province [17] 0 0
Christchurch
Country [18] 0 0
Spain
State/province [18] 0 0
Salamanca
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Liverpool
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Manchester
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Nottingham
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Oxford
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Penarth
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Pernarth
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Stanmore
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Vale of Glamorgan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00051636