A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
- Registration Number
- NCT00541658
- Lead Sponsor
- Warner Chilcott
- Brief Summary
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
- Detailed Description
The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 923
Inclusion Criteria
- Female: 50 years of age or older
- >5 years since last menses natural or surgical
- have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Exclusion Criteria
- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- BMI >32 kg/m
- use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
- hypocalcemia or hypercalcemia of any cause
- markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 mg Before Breakfast risedronate 5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast) 35 mg Before Breakfast risedronate 35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast) 35 mg After Breakfast risedronate 35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
- Primary Outcome Measures
Name Time Method Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population 52 weeks / Endpoint
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population Week 52 / Endpoint Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population Week 26 Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population Week 52 Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population Week 104 Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population Week 104 / Endpoint Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population Week 52 Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population Week 52 / Endpoint Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population Week 52 Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population Week 52 / Endpoint Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population Week 26 Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population Week 52 Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population Week 52 / Endpoint Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population Week 104 Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population Week 104 / Endpoint Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population Week 26 Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population Week 52 Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population Week 52 / Endpoint Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population Week 104 Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population Week 104 / Endpoint Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population Week 26 Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population Week 52 Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint Week 52 / Endpoint Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population Week 104 Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint Week 104 / Endpoint Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population Week 13 Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population Week 26 Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population Week 52 Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population Week 52 / Endpoint Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population Week 104 Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population Week 104 / Endpoint Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population Week 13 Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population Week 26 Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population Week 52 Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population Week 52 / Endpoint Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population Week 104 Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population Week 104 / Endpoint Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population Week 13 Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population Week 26 Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population Week 52 Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population Week 52 / Endpoint Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population Week 104 Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population Week 104 / Endpoint Number of Patients With at Least One New Fractured Vertebra, Week 52 Week 52 Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population Week 52 / Endpoint Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population Week 104 Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population Week 104 / Endpoint Number of Patients With No New Fractured Vertebra, Week 52 Week 52 Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint Week 52 / Endpoint Number of Patients With No New Fractured Vertebra, Week 104 Week 104 Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint Week 104 / Endpoint
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie delayed release risedronate's effect on bone resorption in postmenopausal osteoporosis?
How does weekly 35 mg delayed release risedronate compare to daily 5 mg immediate release in BMD improvement and adverse event profiles?
Which biomarkers correlate with response to delayed release risedronate formulations in postmenopausal osteoporosis trials?
What are the long-term safety implications of delayed release bisphosphonates like risedronate in Warner Chilcott's phase 3 studies?
How does the pharmacokinetic profile of 35 mg DR risedronate influence its efficacy relative to other nitrogen-containing bisphosphonates in osteoporosis management?
Trial Locations
- Locations (2)
Research Site
🇵🇱Warszawa, Poland
Research Facility
🇧🇪Diepenbeek, Belgium
Research Site🇵🇱Warszawa, Poland