Post Menopausal Osteoporosis Clinical Trial
Official title:
A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
Verified date | February 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | USA:FDA |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 308 |
Est. completion date | May 2006 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) | 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). | Baseline, Month 6 | No |
Secondary | Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) | 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). | Baseline, Month 6 | No |
Secondary | Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | 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). | Baseline, Month 6 | No |
Secondary | Percent Change From Baseline to Month 6 in Serum Osteocalcin | 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). | Baseline, Month 6 | No |
Secondary | Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) | 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). | Baseline, Month 6 | No |
Secondary | Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at 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. | Month 6 | No |
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