Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

Study Overview
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Brief Summary
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A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

Official Title
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Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density

Conditions
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Postmenopausal

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal Exclusion Criteria: use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug: oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day) anabolic steroids estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring progestogen calcitonin vitamin D supplements (greater than 800 IU per day) calcitriol, calcidiol, or alfacalcidol any bisphosphonate fluoride (10 mg per day) strontium and other bone active agents parathyroid hormone heparin, warfarin, and other similar anticoagulants

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>5 mg risedronate, once daily for 6 months | Drug: risedronate<br>* tablet, 5 mg risedronate daily for 6 months<br>|
| Experimental: 2<br>100 mg risedronate, once a month for 6 months | Drug: risedronate<br>* tablet, 100 mg risedronate monthly for 6 months<br>|
| Experimental: 3<br>150 mg risedronate, once a month for 6 months | Drug: risedronate<br>* tablet, 150 mg risedronate monthly for 6 months<br>|
| Experimental: 4<br>200 mg risedronate, once a month for 6 months | Drug: experimental<br>* tablet, 200 mg risedronate monthly for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens |  | 6 months |