Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
Completed · Phase 2
Conditions studied: Postmenopausal
In brief
A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
Key facts
- Study ID
- NCT00577837
- Run by
- Warner Chilcott
- People needed
- 370
- Starts
- 2004-04-01
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2013-04-17
Who can join
Age: 50 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal
You may not qualify if…
- use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:
- oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day)
- anabolic steroids
- estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring
- progestogen
- calcitonin
- vitamin D supplements (greater than 800 IU per day)
- calcitriol, calcidiol, or alfacalcidol
- any bisphosphonate
- fluoride (10 mg per day)
- strontium and other bone active agents
- parathyroid hormone
- heparin, warfarin, and other similar anticoagulants
Where it is running
- Research Site — Daytona Beach, Florida, United States
- Research Site — Gainesville, Florida, United States
- Research Site — Shawnee Mission, Kansas, United States
- Research Site — San Antonio, Texas, United States
- Research Site — Hamilton, Ontario, Canada
- Research Facility — Montreal, Quebec, Canada
- Research Facility — Sainte-Foy, Quebec, Canada
- Research Facility — Zagreb, Croatia
- Research Facility — Amsterdam, Netherlands
- Research Facility — Leiden, Netherlands
- Research Facility — Bialystok, Poland
- Research Site — Lublin, Poland
- Research Site — Warsaw, Poland
- Research Site — Wroclaw, Poland
Full record on ClinicalTrials.gov
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