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

Warner Chilcott

Status and phase: Completed; Phase 2

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: 150 mg; Drug: 75 mg; Drug: 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918749

2009003

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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205 participants in 3 patient groups

150 mg

Active Comparator group

Description:

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

Treatment:

Drug: 150 mg

75 mg

Experimental group

Description:

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

Treatment:

Drug: 75 mg

100 mg

Experimental group

Description:

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

Treatment:

Drug: 100 mg