Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia
Intervention: Zoledronic Acid (Drug); Zoledronic acid (Drug); Zoledronic acid (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis
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
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Superiority of zoledronic acid given annually to placebo in percent change of lumbar spine BMD in women < 5 years from menopause and women > or equal to 5 years from menopause.
Superiority of zoledronic acid given at randomization only to placebo in percent change of lumbar spine BMD in women < 5 years from menopause and women > or equal to 5 years from menopause.
Percent change in lumbar spine BMD at Months 6, 12 and 18.
Percent change in total hip, femoral neck, trochanter, and distal radius BMDs at Months 6, 12, 18, and 24.
Change of bone resorption and formation biochemical markers at Months 1, 3, 6,
9, 12, 15, 18, and 24.
Overall safety and tolerability of zoledronic acid compared to placebo.
Minimum age: 45 Years.
Maximum age: N/A.
- Greater than or equal to 45 years of age
- Osteopenia (lumbar spine bone mineral density [BMD] T-score between -1. 0 and -2. 5, and
BMD T-score > - 2. 5 at the femoral neck)
- Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients
with one Grade 1 vertebral fracture are eligible to participate)
- Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
- Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
For information regarding facilities, please contact the Central Contact, E. Hanover, New Jersey 07936, United States
Novartis patient recruitment website
Starting date: July 2004
Ending date: February 2008
Last updated: January 7, 2008