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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-01-31

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.

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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.

Conditions

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Postmenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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35 mg IRBB

35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Group Type ACTIVE_COMPARATOR

risedronate

Intervention Type DRUG

35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks

35 mg DRFB

35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks

50 mg DRFB

50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks

50 mg DRBB

50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Interventions

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risedronate

35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks

Intervention Type DRUG

risedronate

35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks

Intervention Type DRUG

risedronate

50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks

Intervention Type DRUG

risedronate

50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Intervention Type DRUG

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes