A Phase 4 interventional study of Placebo and ibandronate in Postmenopausal Osteoporosis, sponsored by Hoffmann-La Roche. Completed at 15 sites in Finland. Open to female participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 140 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received monthly oral ibandronate (150 milligrams \[mg\]) for 12 months.
Drug: ibandronate
Participants received monthly oral placebo for 12 months.
Drug: Placebo
po monthly for 12 months
150mg po monthly for 12 months
Also known as: Bonviva/Boniva
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
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.
Time frame: Month 6
| Milestone | Ibandronate | Placebo |
|---|---|---|
| Started | 68 | 72 |
| Completed | 59 | 65 |
| Not completed | 9 | 7 |
| Withdrew: Adverse event | 7 | 3 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Violation of inclusion/exclusion | 0 | 2 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Administrative reasons | 0 | 1 |
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 in BMD | Ibandronate | Placebo |
|---|---|---|
| Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | 3.2 ± 3.7 | -0.1 ± 3.0 |
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 in BMD | Ibandronate | Placebo |
|---|---|---|
| Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 | 2.6 ± 3.1 | 0.3 ± 2.8 |
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 in BMD | Ibandronate | Placebo |
|---|---|---|
| Month 6 (n=62,66) | 0.7 ± 1.9 | 0.0 ± 2.1 |
| Month 12 (n=66,65) | 1.2 ± 2.2 | -0.7 ± 2.5 |
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.
| percent change in bone turnover markers | Ibandronate | Placebo |
|---|---|---|
| sCTX Month 1 (n=68,68) | -44.7 ± 36.5 | -3.8 ± 33.3 |
| sCTX Month 6 (n=62,66) | -53.3 ± 24.3 | -3.5 ± 48.0 |
| sCTX Month 12 (n=65,65) | -42.0 ± 27.9 | 11.6 ± 82.4 |
| P1NP Month 1 (n=68,68) | -23.8 ± 17.2 | -2.3 ± 22.5 |
| P1NP Month 6 (n=60,66) | -62.5 ± 16.3 | -3.7 ± 44.5 |
| P1NP Month 12 (n=64,67) | -48.8 ± 37.2 | 12.5 ± 54.6 |
| TRACP Month 1 (n=68,68) | -31.3 ± 12.0 | -7.3 ± 11.9 |
| TRACP Month 6 (n=62,66) | -32.9 ± 14.8 | -7.1 ± 17.0 |
| TRACP Month 12 (n=65,67) | -27.4 ± 16.5 | -6.3 ± 18.0 |
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.
| percentage of participants | Ibandronate | Placebo |
|---|---|---|
| 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 | 0.0 | 0.0 |
Collected over Adverse events were collected from the date of randomization until 15 days after the end of study at 12 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibandronate | — | 10/70 (14.3%) | 19/70 (27.1%) |
| Placebo | — | 6/70 (8.6%) | 26/70 (37.1%) |
| Event | Ibandronate | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 0/70 | 2/70 |
| Deep vein thrombosisBlood and lymphatic system disorders | 2/70 | 0/70 |
| AgranulocytosisBlood and lymphatic system disorders | 1/70 | 0/70 |
| Anaemia due to gastrointestinal bleedingBlood and lymphatic system disorders | 1/70 | 0/70 |
| Acute pancreatitisInfections and infestations | 1/70 | 0/70 |
| ErysipelasInfections and infestations | 0/70 | 1/70 |
| PneumoniaInfections and infestations | 0/70 | 1/70 |
| Acute pyelonephritisInfections and infestations | 1/70 | 0/70 |
| SepsisInfections and infestations | 1/70 | 0/70 |
| ConcussionGeneral disorders | 1/70 | 0/70 |
| Event | Ibandronate | Placebo |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/70 | 4/70 |
| HeadacheNervous system disorders | 2/70 | 7/70 |
| DiarrhoeaGastrointestinal disorders | 3/70 | 5/70 |
| DyspepsiaGastrointestinal disorders | 0/70 | 5/70 |
| NauseaGastrointestinal disorders | 2/70 | 4/70 |
| InfluenzaInfections and infestations | 4/70 | 2/70 |
| Back painMusculoskeletal and connective tissue disorders | 4/70 | 4/70 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 4/70 | 3/70 |
The intent-to-treat (ITT) population included all participants randomized and who had at least one follow up efficacy data time point available.
| Age, Continuous(years) | Ibandronate | Placebo | Total |
|---|---|---|---|
| Mean | 64.4 ± 7.90 | 63.2 ± 6.83 | 63.79 ± 7.39 |
| Sex: Female, Male(Participants) | Ibandronate | Placebo | Total |
|---|---|---|---|
| Female | 68 | 72 | 140 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche