A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

Hoffmann-La Roche140 enrolled

Overview

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Postmenopausal Osteoporosis

Interventions

PlaceboDRUG

po monthly for 12 months

ibandronateDRUG

150mg po monthly for 12 months

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * post-menopausal women, 50-85 years of age; * any inflammatory rheumatoid disease including polymyalgia rheumatica; * receiving treatment with 5-15 mg/day of prednisolone. Exclusion Criteria: * previous treatment with an iv bisphosphonate at any time; * previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within last year, or \>3 months of treatment within last 2 years; * treatment with parathyroid hormone in last 2 years; * inability to stand or sit in an upright position for at least 60 minutes; * inability to swallow a tablet whole; * history of major gastrointestinal disease.

Locations (15)

Unnamed facility

Hämeenlinna, Finland

Unnamed facility

Helsinki, Finland

Unnamed facility

Helsinki, Finland

Unnamed facility

Helsinki, Finland

Outcomes

Primary Outcomes

Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12

Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.

Time frame: Baseline and Month 12

Secondary Outcomes

Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6

Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.

Time frame: Baseline and Month 6

Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12

Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.

Time frame: Baseline and Months 6 and 12

Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12

Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.

Time frame: Baseline and Months 1, 6 and 12

Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months

Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.

Data from ClinicalTrials.gov

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