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OpenTrials
Completed

NCT Number: NCT00100555

A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.

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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

Univ. of Alabama/Division of Clinical Immunology and Rheumatology, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal women between 45 and 79 years of age
  • Must be osteopenic/osteoporotic

Exclusion criteria

  • Any women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women

Secondary outcomes

  1. To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women

  2. To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 4, 2005
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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