Who is sponsoring NCT00132808?

NCT00132808 is sponsored by Novartis Pharmaceuticals.

What condition does NCT00132808 study?

NCT00132808 studies Osteopenia.

What drugs are being tested in NCT00132808?

Interventions: Zoledronic Acid, Placebo.

What is the status of NCT00132808?

NCT00132808 is currently COMPLETED.

Last reviewed 2016-08-01 · How we verify

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

NCT00132808 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	581
Start date	2004-07
Completion	2008-02

Conditions

Osteopenia

Interventions

Zoledronic Acid
Placebo

Primary outcomes

Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum — Baseline, Month 24
The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).

Countries

United States