Phase 4
N=66
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Post Menopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00303485 ↗Enrolled (actual)
66
Serious AEs
4.6%
Results posted
May 2016
Primary outcome: Primary: Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3 — -70.16; -5.96 Percent change — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Vitamin D and calcium supplementation (Drug); ibandronate [Bonviva/Boniva] (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3 |
-70.16; -5.96 | < 0.0001 sig |
| SECONDARY Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time |
-70.16; -5.96; -73.62; -12.69; -61.19; -21.99 | — |
| SECONDARY Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time |
1.30; -2.42; -12.24; -9.78; -16.41; -12.30 | — |
| SECONDARY Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments |
37.74; -1.72; 29.63; 4.81 | — |
| SECONDARY Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent |
59.2; 58.8; 87.8; 58.8; 87.8; 76.5 | — |
| SECONDARY Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL |
46.9; 41.2; 18.4; 47.1; 10.2; 58.8 | — |
| SECONDARY Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL |
16.3; 23.5; 6.1; 29.4; 2.0; 35.3 | — |
| SECONDARY Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations |
17.23; 22.89 | — |
| SECONDARY Number of Participants With Any Marked Abnormality in Laboratory Parameters |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Any Adverse Event or Serious Adverse Event |
40; 12; 1; 2 | — |
Summary
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is <100 individuals.
Eligibility Criteria
Inclusion Criteria
- women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
- naive to bisphosphonate treatment, or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.
Exclusion Criteria
- patients on hormone replacement therapy (HRT) within the last 3 months;
- patients on other osteoporosis medication within the last 3 months;
- sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
- hypersensitivity to any component of ibandronate;
- contraindication for calcium or vitamin D therapy;
- history of major gastrointestinal upset;
- malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).
Data sourced from ClinicalTrials.gov (NCT00303485). 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.