Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577837
• Other study ID #: 2003134
• Secondary ID: HMR4003K/2001
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2007
• Last updated: April 15, 2013
• Start date: April 2004
• Est. completion date: June 2005

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopausal

Intervention

Drug:
• risedronate
tablet, 5 mg risedronate daily for 6 months
• risedronate
tablet, 100 mg risedronate monthly for 6 months
• risedronate
tablet, 150 mg risedronate monthly for 6 months
• experimental
tablet, 200 mg risedronate monthly for 6 months

Locations

Country	Name	City	State
Canada	Research Site	Hamilton	Ontario
Canada	Research Facility	Montreal	Quebec
Canada	Research Facility	Sainte-Foy	Quebec
Croatia	Research Facility	Zagreb
Netherlands	Research Facility	Amsterdam
Netherlands	Research Facility	Leiden
Poland	Research Facility	Bialystok
Poland	Research Site	Lublin
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
United States	Research Site	Daytona Beach	Florida
United States	Research Site	Gainesville	Florida
United States	Research Site	San Antonio	Texas
United States	Research Site	Shawnee Mission	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Warner Chilcott	Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	Yes
Secondary	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		6 months	Yes