Status:
COMPLETED
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Osteopenia
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Postmenopausal
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT00132808
Start Date
July 1 2004
End Date
February 1 2008
Last Update
September 12 2016
Active Locations (1)
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1
For information regarding facilities, please contact the Central Contact
East Hanover, New Jersey, United States, 07936