A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
- Registration Number
- NCT02598934
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 308
- Women newly diagnosed with postmenopausal osteoporosis
- Naive to prior bisphosphonate therapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibandronate Group 1 Ibandronate Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results. Ibandronate Group 2 Ibandronate Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) Baseline, Month 6 Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) Baseline, Month 6 Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) Baseline, Month 6 Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Percent Change From Baseline to Month 6 in Serum Osteocalcin Baseline, Month 6 Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) Baseline, Month 6 Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6 Month 6 The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.