A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

Study Overview
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Brief Summary
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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
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The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Official Title
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A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: risedronate
* Drug: risedronate
* Drug: risedronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 mg Before Breakfast<br>5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast) | Drug: risedronate<br>* 5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily<br>* Other names: IRBB;|
| Experimental: 35 mg After Breakfast<br>35 mg / Delayed-release Risedronate (Immediately Following Breakfast) | Drug: risedronate<br>* 35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly<br>* Other names: DRFB;|
| Experimental: 35 mg Before Breakfast<br>35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast) | Drug: risedronate<br>* 35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly<br>* Other names: DRBB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population |  | 52 weeks / Endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. | Week 52 | 
| Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population | Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. | Week 52 / Endpoint | 
| Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population | Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. | Week 52 | 
| Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population | Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. | Week 52 / Endpoint | 
| 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 |