Status:
COMPLETED
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
Lead Sponsor:
Warner Chilcott
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
45-80 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00918749
Start Date
May 1 2009
End Date
October 1 2009
Last Update
June 29 2015
Active Locations (6)
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1
Research Site
Daytona Beach, Florida, United States, 32117
2
Research Site
Fort Myers, Florida, United States, 33901
3
Research Site
Honolulu, Hawaii, United States, 96821
4
Research Site
Evansville, Indiana, United States, 47711