Clinical trial NCT00619957: Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2008-02-21
Enrollment: 285
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Documented osteoporosis of the femoral neck and lumbar spine

Exclusion Criteria:

* BMI greater than or equal to 35

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
Secondary outcomes:
measure: Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
measure: Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
measure: Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
measure: Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
timeFrame: Baseline to Month 3
measure: Percent Change From Baseline in CTx, Month 6, ITT Population.
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in CTx, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in CTx, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
measure: Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
timeFrame: Baseline to Month 3
measure: Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
measure: Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
timeFrame: Baseline to Month 3
measure: Percent Change From Baseline in BAP, Month 6, ITT Population.
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in BAP, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in BAP, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
measure: Change From Baseline in Body Height, Month 12, ITT Population.
timeFrame: Baseline to Month 12
measure: Change From Baseline in Body Height, Month 24, ITT Population.
timeFrame: Baseline to Month 24
measure: Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
timeFrame: Baseline to 24 Months/Endpoint
measure: Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Cumulative Incidence of Fractures, 12 Months, ITT Population
timeFrame: Baseline to Month 12
measure: Cumulative Incidence of Fractures, 24 Months, ITT Population
timeFrame: Baseline to Month 24
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Research Site
state: California
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Stuart
country: United States
facility: Research Site
state: Florida
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Wyomissing
country: United States
facility: Research Site
state: Pennsylvania
city: Concord
country: Australia
facility: Research Facility
city: Heidelburg
country: Australia
facility: Research Facility
city: Leuven
country: Belgium
facility: Research Facility
city: Prague
country: Czech Republic
facility: Research Site
city: Angers
country: France
facility: Research Facility
city: Lyon
country: France
facility: Research Site
city: Budapest
country: Hungary
facility: Research Facility
city: Budapest
country: Hungary
facility: Research Site
city: Beirut
country: Lebanon
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Procter and Gamble
name: Dietrich Wenderoth, MD
role: STUDY_DIRECTOR
References:
citation: Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.