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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Etidronic Acid; Risedronate Sodium

Criteria

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