Clinical trial NCT00577837: Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
Official title: Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2007-12-20
Enrollment: 370
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens
timeFrame: 6 months
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Shawnee Mission
country: United States
facility: Research Site
state: Kansas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Facility
state: Quebec
city: Sainte-Foy
country: Canada
facility: Research Facility
state: Quebec
city: Zagreb
country: Croatia
facility: Research Facility
city: Amsterdam
country: Netherlands
facility: Research Facility
city: Leiden
country: Netherlands
facility: Research Facility
city: Bialystok
country: Poland
facility: Research Facility
city: Lublin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
affiliation: Procter and Gamble
name: John Beary, MD
role: STUDY_DIRECTOR
References: