At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 581 enrolled
Drug / intervention
Zoledronic Acid +1 moredrug
Likely dose
Zoledronic acid 5 mg intravenous, administered either at randomization and 12 months (annual dosing) or at randomization onlyAI-extracted
Key inclusion· 4
- ✓Postmenopausal women
- ✓Age 45 years or older
- ✓Lumbar spine bone mineral density T-score between -1.0 and -2.5
- ✓Femoral neck bone mineral density T-score greater than -2.5
Key exclusion· 3
- ✕More than one Grade 1 vertebral fracture
- ✕Any Grade 2 or 3 vertebral fracture
- ✕Vitamin D level less than 15 ng/mL prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 2-year Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Administered Either Annually at Randomization and 12 Months, or Administered at Randomization Only in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia
In Brief
A Phase 3 clinical trial evaluating Zoledronic Acid and Placebo for Osteopenia. Completed, enrolled 581 participants across 1 site.
Detailed Summary
Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteopenia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
First PostedAug 2005
Primary CompletionFeb 2008
TodayJul 2026
First PostedAug 22, 2005
Enrollment StartJul 1, 2004
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.9 years ago
Interventions
Zoledronic Aciddrug
Zoledronic acid 5 mg intravenous
Placebodrug
Physiologic 0.9% normal saline