Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00100620

CZOL446O2306

Details and patient eligibility

About

The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Long duration treatment with corticosteroids (started or ongoing)

Exclusion criteria

• History of osteogenesis imperfecta, multiple myeloma or Paget's disease
• History of Hyperparathyroidism, hyperthyroidism
• History of Osteomalacia

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind