Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

Study Overview
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Brief Summary
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Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.

Official Title
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Study Assessing the Efficacy, Safety, and Pharmacokinetics of 75 and 100 mg Once-a-month Delayed-release Risedronate Formulations Compared to 150 mg Once-a-month Immediate-release Risedronate for 3 Months in Postmenopausal Women Age 45-80

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: 150 mg
* Drug: 75 mg
* Drug: 100 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female, 45 to 80 years of age, in good general health postmenopausal ≥2 years, surgically or naturally body mass index less than or equal to 32 kg/m^2 at screening Exclusion Criteria: no use within 3 months prior, nor use for more than 1 month at any time within 6 months of: glucocorticoids, anabolic steroids, estrogens, selective estrogen-receptor modulators (SERMs), or estrogen-related drugs, progestins, calcitonin, vitamin D supplements (>1200 IU per day), calcitriol, calcidiol, or alfacalcidol at any dose, any bisphosphonate. fluoride (≥10 mg/day), strontium (≥50 mg/day), parathyroid hormone, investigational bone active agents. allergic or abnormal reactions to bisphosphonates history of cancer within 5 years, excluding squamous and basal cell carcinoma with 6 month remission positive pregnancy test no depot injection >10,000 IU vitamin D in previous 9 months. no history of GI disease that requires medication, or history of Crohn's disease, ulcerative colitis, diverticular disease, polyps, or surgery that could have changed GI structure or motility. no history of frequent diarrhea or constipation that requires regular laxative use. no history of alcohol or durg abuse, hyperparathyroidism, cancer previous 5 years, major surgery within 1 month prior to screening, diabetes, uncontrolled hypertension, cardiovascular, hepatic, renal or GI disease. no active hyperthyroidism, osteomalacia, use of anticonvulsant medication, or allergic reaction to bisphosphonates

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 150 mg<br>150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. | Drug: 150 mg<br>* 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.<br>|
| Experimental: 75 mg<br>75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast | Drug: 75 mg<br>* 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast<br>|
| Experimental: 100 mg<br>100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast | Drug: 100 mg<br>* 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence. | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population |  | 2 months | 
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population |  | 3 months | 
| Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA. | 2 months | 
| Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | ITT Population | 3 months | 
| Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | ITT Population | 4 months | 
| Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | ITT Population | 2 months | 
| Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | ITT Population | 3 months | 
| Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | ITT Population | 4 months |