Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis - Full Text View

Sponsors and Collaborators:	Procter and Gamble Sanofi-Aventis
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00619957

Purpose

Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporisis followed by a two year follow-up study.

Condition	Intervention	Phase
Male Osteoporosis	Drug: Placebo tablet Drug: Risedronate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Two-Year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Percent change from baseline in lumbar spine bone mineral density (BMD) over 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent changes in lumbar spine BMD at all time points other than the month 24 primary efficacy time point [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment:	210
Study Start Date:	June 2002
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years	Drug: Placebo tablet one placebo once a week for two years followed by 35 mg risedronate for two years
2: Experimental 35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years	Drug: Risedronate one 35 mg risedronate once a week for two years followed by 35 mg risedronate for two years

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented osteoporosis of thefemoral neck and lumbar spine

Exclusion Criteria:

BMI greater than or equal to 35

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619957

Locations

United States, California
Research Site
Palm Desert, California, United States
United States, Colorado
Research Site
Lakewood, Colorado, United States
United States, Florida
Research Site
Stuart, Florida, United States
United States, Ohio
Research Facility
Cincinnati, Ohio, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
wyomissing, Pennsylvania, United States
Australia
Research Facility
Concord, Australia
Research Facility
Heidelburg, Australia
Belgium
Research Facility
Leuven, Belgium
Czech Republic
Research Site
Prague, Czech Republic
France
Research Facility
Angers, France
Hungary
Research Facility
Budapest, Hungary
Lebanon
Research Site
Beirut, Lebanon
Netherlands
Research Site
Rotterdam, Netherlands
Poland
Research Site
Warsaw, Poland
Research Site
Bialystok, Poland
Research Site
Wroclaw, Poland
United Kingdom
Research Site
London, United Kingdom
Research Site
Sheffield, United Kingdom
Research Site
Newcastle, United Kingdom

Sponsors and Collaborators

Procter and Gamble

Sanofi-Aventis

Investigators

Study Director:

Dietrich Wenderoth, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter and Gamble ( Dietrich Wenderoth, MD )
Study ID Numbers:	2001092 and 2001092 OL
Study First Received:	February 11, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00619957 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Musculoskeletal Diseases
Calcium Channel Blockers
Osteoporosis
Bone Density Conservation Agents

Bone Diseases, Metabolic
Cardiovascular Agents
Bone Diseases
Risedronic acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Osteoporosis
Calcium Channel Blockers
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents

Bone Diseases
Pharmacologic Actions
Membrane Transport Modulators
Musculoskeletal Diseases
Therapeutic Uses
Risedronic acid

ClinicalTrials.gov processed this record on September 11, 2009