The HORIZON Recurrent Fracture Trial: design of a clinical trial in the prevention of subsequent fractures after low trauma hip fracture repair
| Autor: | Kenneth W. Lyles, Jonathan D. Adachi, Cheri Janning, Theresa Rosario-Jansen, Cathleen S. Colón-Emeric, Peter Mesenbrink, Carl F. Pieper, Jay Magaziner, Theodore T. Suh, Zeb D. Horowitz, John Caminis |
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| Rok vydání: | 2004 |
| Předmět: |
Male
medicine.medical_specialty Bone density Tibolone Zoledronic Acid Loading dose law.invention Placebos Randomized controlled trial Bone Density law Concomitant Therapy medicine Humans Vitamin D Randomized Controlled Trials as Topic Hip fracture Diphosphonates Hip Fractures business.industry Developed Countries Imidazoles General Medicine Middle Aged medicine.disease Surgery Clinical trial Zoledronic acid Calcium Female business medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 20:903-910 |
| ISSN: | 1473-4877 0300-7995 |
| DOI: | 10.1185/030079904125003683 |
| Popis: | To present the novel design of a trial testing the safety and efficacy of a yearly bisphosponate, zoledronic acid, in preventing new clinical fractures in patients with recent low trauma hip fracture repair.Randomized, placebo-controlled, triple-blind study. One hundred and fifteen clinical centers worldwide are recruiting approximately 1714 subjects aged 50 years and over (no upper age limit, median age of enrolled subjects to date 79 years) who have undergone surgical repair of a low trauma hip fracture in the preceding 90 days. Patients will be assigned at random to an intervention group (5 mg zoledronic acid intravenously yearly) or a control group (placebo infusion yearly). Both groups receive a loading dose of Vitamin D2 or D3 IM or orally, followed by 800-1200 IU Vitamin D and 1000-1500 mg elemental calcium orally on a daily basis. Concomitant therapy with calcitonin, hormone replacement therapy, selective estrogen receptor modulators, tibolone, and external hip protectors are allowed.The primary endpoint is subsequent skeletal fractures as adjudicated by a clinical endpoints committee blinded to intervention status. Secondary outcomes include delayed hip fracture healing, changes in bone mineral density, and health resource utilization. Subjects will be recruited over a 3-4 year period and will be followed until 211 primary endpoints are accrued and adjudicated.This randomized clinical trial is novel among osteoporosis therapies as it (1). targets hip fracture patients, a previously understudied group, and (2). uses only clinically evident fractures as the primary outcome. Ethical and practical considerations in studying this frail population are discussed. |
| Databáze: | OpenAIRE |
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