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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00619957
Registration number
NCT00619957
Ethics application status
Date submitted
11/02/2008
Date registered
21/02/2008
Date last updated
28/10/2011
Titles & IDs
Public title
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
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Scientific 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
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Secondary ID [1]
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2001092 and 2001092 OL
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Other Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Risedronate
Placebo comparator: 1 - Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
Experimental: Risedronate - 35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years
Treatment: Drugs: Placebo tablet
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
Treatment: Drugs: Risedronate
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline to 24 Months/Endpoint
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Secondary outcome [1]
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Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline to Month 6
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Secondary outcome [2]
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Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
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Assessment method [2]
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0
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).
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Timepoint [2]
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Baseline to Month 12
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Secondary outcome [3]
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Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline to Month 24
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Secondary outcome [4]
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Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline to Month 6
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Secondary outcome [5]
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Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
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Assessment method [5]
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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).
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Timepoint [5]
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Baseline to Month 12
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Secondary outcome [6]
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Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
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Assessment method [6]
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0
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).
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Timepoint [6]
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Baseline to Month 24
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Secondary outcome [7]
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Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
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Assessment method [7]
0
0
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).
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Timepoint [7]
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Baseline to 24 Months/Endpoint
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Secondary outcome [8]
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Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
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Assessment method [8]
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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
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Timepoint [8]
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Baseline to Month 6
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Secondary outcome [9]
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Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
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Assessment method [9]
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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
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Timepoint [9]
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Baseline to Month 12
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Secondary outcome [10]
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Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
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Assessment method [10]
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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
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Timepoint [10]
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Baseline to Month 24
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Secondary outcome [11]
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Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
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Assessment method [11]
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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
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Timepoint [11]
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Baseline to 24 Months/Endpoint
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Secondary outcome [12]
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Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
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Assessment method [12]
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DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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Timepoint [12]
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Baseline to Month 6
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Secondary outcome [13]
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Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
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Assessment method [13]
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DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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Timepoint [13]
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Baseline to Month 12
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Secondary outcome [14]
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Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
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Assessment method [14]
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DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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Timepoint [14]
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Baseline to Month 24
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Secondary outcome [15]
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Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
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Assessment method [15]
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DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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Timepoint [15]
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Baseline to 24 Months/Endpoint
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Secondary outcome [16]
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Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
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Assessment method [16]
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Timepoint [16]
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Baseline to Month 3
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Secondary outcome [17]
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Percent Change From Baseline in CTx, Month 6, ITT Population.
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Assessment method [17]
0
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Timepoint [17]
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Baseline to Month 6
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Secondary outcome [18]
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Percent Change From Baseline in CTx, Month 12, ITT Population.
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Assessment method [18]
0
0
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Timepoint [18]
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Baseline to Month 12
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Secondary outcome [19]
0
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Percent Change From Baseline in CTx, Month 24, ITT Population.
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Assessment method [19]
0
0
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Timepoint [19]
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Baseline to Month 24
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Secondary outcome [20]
0
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Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
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Assessment method [20]
0
0
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Timepoint [20]
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Baseline to 24 Months/Endpoint
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Secondary outcome [21]
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Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
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Assessment method [21]
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0
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Timepoint [21]
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Baseline to Month 3
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Secondary outcome [22]
0
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Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
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Assessment method [22]
0
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Timepoint [22]
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Baseline to Month 6
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Secondary outcome [23]
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Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
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Assessment method [23]
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Timepoint [23]
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Baseline to Month 12
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Secondary outcome [24]
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Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
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Assessment method [24]
0
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Timepoint [24]
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Baseline to Month 24
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Secondary outcome [25]
0
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Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
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Assessment method [25]
0
0
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Timepoint [25]
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Baseline to 24 Months/Endpoint
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Secondary outcome [26]
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Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
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Assessment method [26]
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Timepoint [26]
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Baseline to Month 3
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Secondary outcome [27]
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Percent Change From Baseline in BAP, Month 6, ITT Population.
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Assessment method [27]
0
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Timepoint [27]
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Baseline to Month 6
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Secondary outcome [28]
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Percent Change From Baseline in BAP, Month 12, ITT Population.
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Assessment method [28]
0
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Timepoint [28]
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Baseline to Month 12
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Secondary outcome [29]
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Percent Change From Baseline in BAP, Month 24, ITT Population.
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Assessment method [29]
0
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Timepoint [29]
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Baseline to Month 24
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Secondary outcome [30]
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Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
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Assessment method [30]
0
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Timepoint [30]
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Baseline to 24 Months/Endpoint
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Secondary outcome [31]
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Change From Baseline in Body Height, Month 12, ITT Population.
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Assessment method [31]
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Timepoint [31]
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Baseline to Month 12
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Secondary outcome [32]
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Change From Baseline in Body Height, Month 24, ITT Population.
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Assessment method [32]
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Timepoint [32]
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Baseline to Month 24
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Secondary outcome [33]
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Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
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Assessment method [33]
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Timepoint [33]
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Baseline to 24 Months/Endpoint
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Secondary outcome [34]
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Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
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Assessment method [34]
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responder = positive change (\>0) in lumbar spine BMD from Baseline to Month 24
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Timepoint [34]
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Baseline to Month 24
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Secondary outcome [35]
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Cumulative Incidence of Fractures, 12 Months, ITT Population
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Assessment method [35]
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Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
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Timepoint [35]
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Baseline to Month 12
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Secondary outcome [36]
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Cumulative Incidence of Fractures, 24 Months, ITT Population
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Assessment method [36]
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Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
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Timepoint [36]
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Baseline to Month 24
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Eligibility
Key inclusion criteria
* Documented osteoporosis of the femoral neck and lumbar spine
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* BMI greater than or equal to 35
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2007
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Sample size
Target
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Accrual to date
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Final
285
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Facility - Concord
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Recruitment hospital [2]
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Research Facility - Heidelburg
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Heidelburg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
0
0
United States of America
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State/province [2]
0
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Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
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Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Ohio
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Oregon
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Pennsylvania
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Leuven
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Country [9]
0
0
Czech Republic
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State/province [9]
0
0
Prague
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Country [10]
0
0
France
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State/province [10]
0
0
Angers
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Country [11]
0
0
France
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State/province [11]
0
0
Lyon
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Country [12]
0
0
Hungary
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State/province [12]
0
0
Budapest
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Country [13]
0
0
Lebanon
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State/province [13]
0
0
Beirut
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Country [14]
0
0
Netherlands
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State/province [14]
0
0
Rotterdam
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Country [15]
0
0
Poland
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State/province [15]
0
0
Bialystok
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Country [16]
0
0
Poland
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State/province [16]
0
0
Warsaw
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Country [17]
0
0
Poland
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State/province [17]
0
0
Wroclaw
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Country [18]
0
0
United Kingdom
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State/province [18]
0
0
London
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Country [19]
0
0
United Kingdom
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State/province [19]
0
0
Newcastle
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Country [20]
0
0
United Kingdom
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State/province [20]
0
0
Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Warner Chilcott
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Sanofi
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00619957
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
0
0
Dietrich Wenderoth, MD
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Address
0
0
Procter and Gamble
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00619957
Download to PDF