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A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients

NCT02598934•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women newly diagnosed with postmenopausal osteoporosis
•Naive to prior bisphosphonate therapy

Exclusion Criteria

•Inability to stand or sit upright for at least 60 minutes
•Inability to swallow a tablet whole
•Hypersensitivity to any component of ibandronate
•Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
•Other osteoporosis drug within last 3 months
•Malignant disease diagnosed within previous 10 years, except resected basal cell cancer

Locations (53)

Montgomery, Alabama, United States

Chandler, Arizona, United States

Peoria, Arizona, United States

Hot Springs, Arkansas, United States

Pine Bluff, Arkansas, United States

Anaheim, California, United States

Beverly Hills, California, United States

Carmichael, California, United States

Wilmington, Delaware, United States

DeLand, Florida, United States

Key Dates

Start Date

August 1, 2004

Primary Completion Date

May 1, 2006

Completion Date

May 1, 2006

Last Updated

March 9, 2016

Enrollment

308

ACTUAL participants

Conditions

Post Menopausal Osteoporosis

Interventions

Ibandronate

DRUG

Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis

NCT05571514

Post Menopausal Osteoporosis

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COMPLETED

Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France

NCT02347865

Post Menopausal Osteoporosis

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COMPLETEDPHASE4

A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

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 9, 2016Data 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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A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

Inclusion Criteria

Exclusion Criteria

Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis

Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France

A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis