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

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 osteopenia.

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

Primary outcome:

Primary objective:

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.

Secondary outcome:

Secondary objectives:

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. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

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