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Tiludronate: development as an osteoporosis therapy

C H Chesnut1

  • 1Division of Nuclear Medicine RC-70, University of Washington Medical Center, Seattle 96195, USA.

Bone
|November 1, 1995
PubMed
Summary

Tiludronate is being investigated for osteoporosis treatment, with studies focusing on fracture incidence and bone mineral density. Safety and quality of life are also key assessment areas in this clinical trial program.

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Area of Science:

  • Bone Metabolism and Therapeutics
  • Clinical Trial Design

Background:

  • Tiludronate (tiludronic acid, disodium salt) is currently in clinical development for Paget's disease of bone.
  • Osteoporosis is anticipated to become a significant indication for tiludronate therapy.

Purpose of the Study:

  • To describe the trial design and treatment goals for new clinical studies investigating tiludronate for osteoporosis.
  • To evaluate tiludronate's efficacy and safety in treating osteoporosis.

Main Methods:

  • Fracture incidence studies: Primary endpoint is vertebral fractures after 3 years; secondary endpoints include bone mineral density (BMD), spinal deformity index, height, biochemical markers, and quality of life.
  • Non-fracture studies: Primary endpoint is BMD change after 2 years; secondary endpoints include fracture rate, spinal deformity index, height, biochemical markers, quality of life, and safety.
  • Safety evaluations include laboratory parameters, adverse events, and bone histomorphometry in selected patients.

Main Results:

  • Study designs are established for evaluating tiludronate in osteoporosis.
  • Specific primary and secondary efficacy endpoints are defined for both fracture and non-fracture studies.
  • Comprehensive safety assessments, including bone biopsies, are incorporated.

Conclusions:

  • New clinical trials are designed to establish tiludronate as a treatment for osteoporosis.
  • The studies aim to provide robust data on efficacy, safety, and patient-reported outcomes.
  • Anticipated completion in early 1997, followed by regulatory submissions.

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