A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|