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OpenTrials
Completed

NCT Number: NCT00097812

Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

45 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis, Nuremberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-menopausal women between 45 and 79 years of age
  • Must be osteopenic/osteoporotic
  • Treatment with oral bisphosphonate for at least 1 year

Exclusion criteria

  • Any woman of child bearing potential
  • Treatment with other bone active agents

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations

Secondary outcomes

  1. To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations

  2. To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients

  3. To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Dec 1, 2004
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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