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Completed

NCT Number: NCT00051636

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

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.

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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, Concord, Australia

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Who can participate

Healthy volunteers accepted: No

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

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

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.

Treatment and study plan

Zoledronic acid

Drug

Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.

Other names: Reclast, Aclasta

risedronate

Drug

Oral risedronate 30 mg capsules.

Other names: Actonel

Placebo to Risedronate

Drug

Oral placebo of risedronate capsules.

Placebo to zoledronic acid

Drug

5 mL of sterile water one dose intravenous infusion.

Calcium and Vitamin D

Dietary Supplement

Calcium and vitamin D supplements were supplied.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28

    Time frame: Baseline and day 28

    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 Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10

    Time frame: Baseline and day 10

    The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.

  4. Time to First Therapeutic Response

    Time frame: 182 days

    A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) 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 Relative to Baseline

    Time frame: Baseline and day 28

    Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.

  6. Change in Pain Severity Score

    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 Score

    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 the 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 Observational Period

Important dates

Study start
2001
Primary completion
2004
Study completion
2011
First posted
Jan 15, 2003
Registry last updated
May 15, 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.

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