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

• Sponsor: Warner Chilcott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00577837
• Collaborator: Sanofi (Industry)
• Enrollment: 370
• Locations: 14
• Arms: 4
• Duration (Months): 14
• Patients Per Site: 26.4
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal	Drug: risedronate; Drug: risedronate; Drug: risedronate; Drug: experimental	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 370 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2004
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 5 mg risedronate, once daily for 6 months	Drug: risedronate; tablet, 5 mg risedronate daily for 6 months
Experimental: 2 100 mg risedronate, once a month for 6 months	Drug: risedronate; tablet, 100 mg risedronate monthly for 6 months
Experimental: 3 150 mg risedronate, once a month for 6 months	Drug: risedronate; tablet, 150 mg risedronate monthly for 6 months
Experimental: 4 200 mg risedronate, once a month for 6 months	Drug: experimental; tablet, 200 mg risedronate monthly for 6 months

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Daytona Beach	Florida	United States
2	Research Site	Gainesville	Florida	United States
3	Research Site	Shawnee Mission	Kansas	United States
4	Research Site	San Antonio	Texas	United States
5	Research Site	Hamilton	Ontario	Canada
6	Research Facility	Montreal	Quebec	Canada
7	Research Facility	Sainte-Foy	Quebec	Canada
8	Research Facility	Zagreb		Croatia
9	Research Facility	Amsterdam		Netherlands
10	Research Facility	Leiden		Netherlands
11	Research Facility	Bialystok		Poland
12	Research Site	Lublin		Poland
13	Research Site	Warszawa		Poland
14	Research Site	Wroclaw		Poland

Sponsors and Collaborators

• Warner Chilcott
• Sanofi

Investigators

• Study Director: John Beary, MD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT00577837
• Other Study ID Numbers: 2003134; HMR4003K/2001
• First Posted: Dec 20, 2007
• Last Update Posted: Apr 17, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Risedronic Acid; Etidronic Acid

Study Results

No Results Posted as of Apr 17, 2013