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

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteopenia

Treatments: Drug: Placebo; Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00132808

CZOL446N2312

Details and patient eligibility

About

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.

Enrollment: 581 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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581 participants in 3 patient groups, including a placebo group

Zoledronic Acid 2x5 mg

Experimental group

Description:

Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12

Treatment:

Drug: Zoledronic Acid

Zoledronic Acid 1x5 mg

Experimental group

Description:

Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12

Treatment:

Drug: Placebo

Drug: Zoledronic Acid

Placebo

Placebo Comparator group

Description:

Placebo given at randomization and Month 12

Treatment:

Drug: Placebo