NCT00439244

Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

A One-year Partial Double-blinded, Randomized, Multi-center, Multi-national Study to Assess the Effects of Combination Therapy of Annual Zoledronic Acid (5 mg) and Daily Subcutaneous Teriparatide (2mcrg) on Postmenopausal Women With Severe Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Novartis · Industry
• Sex: Female
• Age: 45 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Zoledronic acid	Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid.
DRUG	Placebo	Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to allow an infusion of 100 mL total volume in a ready-to-infuse plastic bottle
DRUG	Teriparatide	Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each pre-filled delivery device is filled with 3.3 mL to deliver 3 mL. Each mL contains 250 μg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetate acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge pre-assembled into a pen device delivers 20 μg of teriparatide per dose each day for up to 28 days.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-02-23
• Last updated: 2011-04-20
• Results posted: 2011-04-20

Locations

33 sites across 4 countries: United States, Belgium, Germany, Spain