Skip to main content
OpenTrials
Completed

NCT Number: NCT00103740

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Paget's Disease of Bone Bone Diseases Musculoskeletal Diseases Osteitis Deformans

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Fitzroy, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 30 years or older
  • SAP 2 times 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

Exclusion criteria

  • Allergic reaction to bisphosphonates
  • History of upper GI disorders
  • History of iritis, uveitis
  • Calculated creatinine clearance < 30 ml/min at baseline
  • Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Zoledronic acid

Drug

5 mg zoledronic acid in 5 mL of sterile water for infusion

Placebo to zoledronic acid

Drug

5 mL of sterile water for infusion

risedronate

Drug

30mg oral tablets overencapsulated to match the placebo capsules

Placebo to Risedronate

Drug

oral capsules

Calcium and vitamin D supplements

Drug

Calcium and vitamin D supplements were supplied

Primary outcomes

  1. Number of Patients Who Had Therapeutic Response at 6 Months

    Time frame: Baseline, 6 months

    A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.

Secondary outcomes

  1. Relative Change in Serum Alkaline Phosphatase in U/L at Day 28

    Time frame: Baseline and 28 days

    The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.

  2. Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10

    Time frame: Baseline and day 10

    The percent change in serum C-telopeptide from baseline to Day 10 was measured.

  3. Relative Change in Urine α-CTx in ug/mmol at Day 10

    Time frame: Baseline and day 10

    The percent change in urine α-CTx from baseline to Day 10 was measured.

  4. Time to First Therapeutic Response

    Time frame: 182 days

    Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.

  5. Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28

    Time frame: Day 28

    Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years).

  6. Change in Pain Severity at Day 182

    Time frame: Baseline and day 182

    Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.

  7. Change in Pain Interference at Day 182

    Time frame: Baseline and day 182

    Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.

  8. Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period

    Time frame: 8 years was the maximum

    Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.

  9. Number of Participants With a Partial Disease Relapse During the Extended Observation Period

    Time frame: 8 years was the maximum

    Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit.

  10. Number of Participants With a Disease Relapse During the Extended Observation Period

    Time frame: 8 years was maximum

    Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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 Observation Period

Important dates

Study start
2002
Primary completion
2003
Study completion
2011
First posted
Feb 15, 2005
Registry last updated
Jun 4, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.