A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years

Novartis

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909961

CZOL446HTR04

Details and patient eligibility

About

This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.

Enrollment: 118 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal osteoporosis
• Patients who has a low bone mineral density at hip or vertebral
• Patients who has an osteoporotic fracture at hip or vertebra

Exclusion criteria

• Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
• Known metabolic bone disease excluding osteoporosis.
• Serious systemic disorder treated with drugs interfering with bone metabolism.
• Significant liver or renal failure
• Pathologic fracture in the examined body area or elsewhere.
• Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
• Patients with hypocalcaemia

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

118 participants in 1 patient group

Zoledronic acid

Experimental group

Treatment:

Drug: Zoledronic acid