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

Tracking Information

First Received Date ^ICMJE

December 19, 2007

Last Updated Date

February 5, 2008

Start Date ^ICMJE

April 2004

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00577837 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Postmenopausal

Intervention ^ICMJE

Drug: risedronate
Drug: experimental

Study Arms / Comparison Groups

Active Comparator: 5 mg risedronate, once daily for 6 months
Experimental: 100 mg risedronate, once a month for 6 months
Experimental: 150 mg risedronate, once a month for 6 months
Experimental: 200 mg risedronate, once a month for 6 months

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

370

Completion Date

June 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Croatia, Netherlands, Poland

Administrative Information

NCT ID ^ICMJE

NCT00577837

Responsible Party

Dietrich H Wenderoth, MD, Proctor and Gamble

Study ID Numbers ^ICMJE

2003134, HMR4003K/2001

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

Sanofi-Aventis

Investigators ^ICMJE

Study Director:

John Beary, MD

Procter and Gamble

Information Provided By

Procter and Gamble

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP