A study to compare zoledronic acid and calcium and vitamin D, with placebo (dummy) and calcium and vitamin D, on the frequency of hip fractures and of new spinal fractures in post-menopausal women with osteoporosis

Completed

• Conditions: Musculoskeletal Diseases: Osteoporosis; Musculoskeletal Diseases; Osteoporosis

• Registration Number: ISRCTN16703536
• Lead Sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 7400

Inclusion Criteria

Post-menopausal women with osteoporosis.

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 31 July 2008:<br>1. To assess the incidence of hip fractures in all patients treated with zoledronic acid compared to patients in the placebo group at 3 years<br>2. To assess the incidence of new vertebal fractures in patients treated with zolendronate acid compared to patients taking placebo at 3 years among patients not taking concomitant therapy for osteoporosis at baseline (stratum 1)

Secondary Outcome Measures

Name	Time	Method
Added 31 July 2008:<br>1. Percent change in hip BMD as measured by DXA over 3 years<br>2. Proportion of patients in stratum 1 with new and/or worsening vertebral fractures at 1 year<br>3. Incidence of all clinical fractures in stratum 1 and 2 over 3 years