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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-10-31

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.

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Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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150 mg

150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.

Group Type ACTIVE_COMPARATOR

150 mg

Intervention Type DRUG

150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.

75 mg

75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast

Group Type EXPERIMENTAL

75 mg

Intervention Type DRUG

75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

100 mg

100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast

Group Type EXPERIMENTAL

100 mg

Intervention Type DRUG

100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Interventions

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150 mg

150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.

Intervention Type DRUG

75 mg

75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Intervention Type DRUG

100 mg

100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Intervention Type DRUG

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes