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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
285
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Research Site
Palm Desert, California, United States
Research Site
Lakewood, Colorado, United States
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to Month 6
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Time frame: Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Stuart, Florida, United States
Research Site
St Louis, Missouri, United States
Research Facility
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Wyomissing, Pennsylvania, United States
Research Facility
Concord, Australia
Research Facility
Heidelburg, Australia
Research Facility
Leuven, Belgium
...and 13 more locations
Time frame: Baseline to Month 6
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Time frame: Baseline to Month 12
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Time frame: Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to Month 6
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to Month 12
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to Month 24
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to Month 6
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to Month 12
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to Month 24
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
Time frame: Baseline to Month 3
Percent Change From Baseline in CTx, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in CTx, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in CTx, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
Time frame: Baseline to Month 3
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
Time frame: Baseline to Month 3
Percent Change From Baseline in BAP, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in BAP, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in BAP, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Change From Baseline in Body Height, Month 12, ITT Population.
Time frame: Baseline to Month 12
Change From Baseline in Body Height, Month 24, ITT Population.
Time frame: Baseline to Month 24
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
responder = positive change (\>0) in lumbar spine BMD from Baseline to Month 24
Time frame: Baseline to Month 24
Cumulative Incidence of Fractures, 12 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Time frame: Baseline to Month 12
Cumulative Incidence of Fractures, 24 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
Time frame: Baseline to Month 24