Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
Completed · Phase 2
Conditions studied: Postmenopausal Osteoporosis
In brief
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.
Key facts
- Study ID
- NCT00918749
- Run by
- Warner Chilcott
- People needed
- 205
- Starts
- 2009-05-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2015-06-29
Who can join
Age: 45 and older, up to 80. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Daytona Beach, Florida, United States
- Research Site — Fort Myers, Florida, United States
- Research Site — Honolulu, Hawaii, United States
- Research Site — Evansville, Indiana, United States
- Research Site — Austin, Texas, United States
- Research Site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.