Phase 4
Completed N=308
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
Post Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT02598934 ↗
Enrolled (actual)
308
Serious AEs
5.5%
Results posted
Mar 2016
Primary outcomePrimary: Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) — -55.26 percent change
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) |
-55.26 | — |
| SECONDARY Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) |
-45.98 | — |
| SECONDARY Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) |
-58.14 | — |
| SECONDARY Percent Change From Baseline to Month 6 in Serum Osteocalcin |
-41.51 | — |
| SECONDARY Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) |
-35.34 | — |
| SECONDARY Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6 |
68.8; 51.9; 64.9; 50.0; 72.1; 55.2 | 0.002 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02598934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.