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Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density | Clinical Trials | Clareo Health

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Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density

A Multi-center, Randomized, Double-blind, Double-dummy Study in Postmenopausal Women With Low Bone Mineral Density to Compare the Effects of a Single Dose of i.v. Zoledronic Acid 5 mg, With Daily Oral Raloxifene 60 mg OD on Bone Turnover Markers

NCT00431444•Novartis

View on ClinicalTrials.gov

Summary

This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.

Eligibility

Age

45 - 80 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:
•Cessation of menses for 18 months in women \< 50 years of age
•Cessation of menses for 12 months in women age 50 years or over
•Documented bilateral oophorectomy at least 1 year previously
•Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis
•Signed informed consent prior to initiation of any study procedure

Exclusion Criteria

•Prior treatment with i.v. bisphosphonates within the last 2 years
•Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks\*).
•\*NOTE: If used less than 8 weeks, the washout period is 6 months.
•Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
•Any treatment with strontium renalate, sodium fluoride or parathyroid hormone
•Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year
•Treatment with any investigational drug within 30 days prior to randomization
•Any woman of child bearing potential
•Patients with fractures occurring within three months prior to randomization
•History of hypersensitivity to bisphosphonates
+11 more criteria

Locations (17)

Women's Health Research

Phoenix, Arizona, United States

Associated Pharma Research Center

Buena Park, California, United States

Washington D.C., District of Columbia, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Women's Physicians of Jacksonville

Jacksonville, Florida, United States

Tampa Clinical Research

Tampa, Florida, United States

Springfield Clinic

Springfield, Illinois, United States

Consultants in Women's Health Care

St Louis, Missouri, United States

Alegent Health

Omaha, Nebraska, United States

Specialty Medical and Research Center

Pahrump, Nevada, United States

Key Dates

Start Date

January 1, 2007

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

March 29, 2011

Enrollment

110

ACTUAL participants

Conditions

Osteoporosis

Interventions

Raloxifene

DRUG

Zoledronic acid

DRUG

Placebo oral pills

DRUG

Placebo intravenous (i.v.) infusion

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITING

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Parkinson DiseaseStroke+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

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