The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
5 mg/day
placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8
Investigational Site
Concord, New South Wales, Australia
Investigational Site
Parkville, Victoria, Australia
Investigational Site
De Pintelaan 185, Gent, Belgium
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site
Hvidovre, Denmark, Denmark
Investigational Site
Oulu, Finland, Finland
Investigational Site
Siena, Italy, Italy
Investigational Site
Warsaw, Poland, Poland
Investigational Site
Warsaw, Poland, Poland
Investigational Site
Warsaw, Poland, Poland
Investigational Site
Warsaw, Poland, Poland
...and 3 more locations
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)