Expired Study
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Unavailable, Kansas


Purpose:

Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.


Criteria:

Inclusion Criteria: - Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive - Low bone mineral density Exclusion Criteria: - Certain prior treatments for low bone mass/osteopenia - Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation - Impaired kidney function Other protocol-defined inclusion/exclusion criteria may apply.


Study is Available At:


Original ID:

CZOL446H2407


NCT ID:

NCT00145275


Secondary ID:


Study Acronym:


Brief Title:

To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Po


Official Title:

To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

45 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

455


Enrollment Type:


Study Dates

Start Date:December 2004
Completion Date:October 2005
Completion Type:Actual
Primary Completion Date:October 2005
Primary Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 26, 2012
First Received Date:September 1, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:VAS (visual analog scale)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Questionnaires
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Temperature increase
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:zoledronic acid

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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