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

Hoffmann-La Roche308 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

308

Conditions

Post Menopausal Osteoporosis

Interventions

IbandronateDRUG

Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)

Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

Time frame: Baseline, Month 6

Secondary Outcomes

Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)

Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

Time frame: Baseline, Month 6

Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

Time frame: Baseline, Month 6

Percent Change From Baseline to Month 6 in Serum Osteocalcin

Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

Time frame: Baseline, Month 6

Data from ClinicalTrials.gov

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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Peoria, Arizona, United States

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Hot Springs, Arkansas, United States

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Pine Bluff, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Carmichael, California, United States

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Wilmington, Delaware, United States

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DeLand, Florida, United States

...and 43 more locations