Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteopenia

In brief

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.

Key facts

Study ID

NCT00132808

Run by

Novartis Pharmaceuticals

People needed

581

Starts

2004-07-01

Expected to finish

2008-02-01

Last updated by the study team

2016-09-12

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• For information regarding facilities, please contact the Central Contact — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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