Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

Study Overview
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Brief Summary
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To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Detailed Description
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To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Official Title
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Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women

Conditions
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Postmenopausal Women

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In generally good health, as determined by medical history, physical examination, and laboratory test results Postmenopausal greater than 2 years, naturally or surgically based on medical history. Exclusion Criteria: Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing: oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day) anabolic steroids estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs progestins calcitonin vitamin D supplements calcitriol, calcidiol, or alfacalcidol at any dose any bisphosphonate fluoride strontium parathyroid hormone, including teriparatide

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 35 mg IRBB<br>35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | Drug: risedronate<br>* 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks<br>|
| Experimental: 35 mg DRFB<br>35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | Drug: risedronate<br>* 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks<br>|
| Experimental: 50 mg DRFB<br>50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | Drug: risedronate<br>* 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks<br>|
| Experimental: 50 mg DRBB<br>50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | Drug: risedronate<br>* 50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population |  | Baseline and Week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population |  | Baseline and Week 13 | 
| Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population |  | Baseline and Week 13 |