A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
|ClinicalTrials.gov Identifier: NCT00545051|
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : May 12, 2016
Last Update Posted : May 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Osteoporosis||Drug: Placebo Drug: ibandronate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women|
|Study Start Date :||May 2006|
|Primary Completion Date :||May 2009|
|Study Completion Date :||May 2009|
Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months.
150mg po monthly for 12 months
Other Name: Bonviva/Boniva
Placebo Comparator: Placebo
Participants received monthly oral placebo for 12 months.
po monthly for 12 months
- Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 [ Time Frame: Baseline and 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.
- Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 [ Time Frame: Baseline and 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.
- Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 [ Time Frame: Baseline and Months 6 and 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.
- Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12 [ Time Frame: Baseline and Months 1, 6 and 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.
- 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 [ Time Frame: Month 6 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545051
|Helsinki, Finland, 00100|
|Helsinki, Finland, 00290|
|Helsinki, Finland, 00350|
|Hyvinkää, Finland, 05800|
|Hämeenlinna, Finland, 13530|
|Jyvaeskylae, Finland, 10100|
|Jyväskylä, Finland, 40100|
|Kuopio, Finland, 70211|
|Lahti, Finland, 15110|
|Oulu, Finland, 90029|
|Oulu, Finland, 90100|
|Tampere, Finland, 33100|
|Tampere, Finland, 33101|
|Turku, Finland, 20100|
|Vantaa, Finland, 01300|
|Study Director:||Clinical Trials||Hoffmann-La Roche|