Postmenopausal Women With Osteoporosis
Conditions
Keywords
Postmenopausal Women, Osteoporosis
Brief summary
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.
Interventions
DRUGRisedronate
5 mg/day
DRUGPlacebo/Risedronate
placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 85 Years
Healthy volunteers
No
Inclusion criteria
* Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080
Exclusion criteria
* Less than 60% compliant between drug start and month 21 * Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection \>10,000 IU vitamin D, investigational drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population | Baseline Core Study (Year 1) to Month 6 (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). |
| Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population | Baseline Core Study (Year 1) to Month 12 (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). |
| Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 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). |
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population | Baseline Core Study (Year 1) to Month 6 (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). |
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population | Baseline Core Study (Year 1) to 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). |
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 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). |
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population | Baseline Core Study (Year 1) to Month 6 (Year 8) | 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). |
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population | Baseline Core Study (Year 1) to Month 12 (Year 8) | 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). |
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 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). |
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population | Baseline Core Study (Year 1) to Month 6 (Year 8) | 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). |
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population | Baseline Core Study (Year 1) to Month 12 (Year 8) | 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). |
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 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). |
Countries
Australia, Belgium, Denmark, Finland, Italy, Poland, Spain, Sweden
Participant flow
Recruitment details
Screening began 4 October 2001
Pre-assignment details
Patients who sequentially completed Clinical Studies RVE009093 (3 year core study), RVE1996077 Year 4/5 extension study) and RVE1998080 (Year 6/7 extension study) were eligible for screening. \[No NCT numbers available\]
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Risedronate Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8 | 30 |
| Risedronate Risedronate 5mg years 1-7, no drug year 8 | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo/Risedronate | Risedronate | Total |
|---|---|---|---|
| Age Continuous | 66.9 Participants STANDARD_DEVIATION 6.24 | 67.3 Participants STANDARD_DEVIATION 5.79 | 67.1 Participants STANDARD_DEVIATION 5.97 |
| Age, Customized < 65 years old | 11 Participants | 9 Participants | 20 Participants |
| Age, Customized > or = 65 years old | 19 Participants | 22 Participants | 41 Participants |
| Race/Ethnicity, Customized Caucasian | 30 participants | 31 participants | 61 participants |
| Region of Enrollment Australia | 4 participants | 3 participants | 7 participants |
| Region of Enrollment Belgium | 0 participants | 2 participants | 2 participants |
| Region of Enrollment Denmark | 5 participants | 3 participants | 8 participants |
| Region of Enrollment Finland | 1 participants | 3 participants | 4 participants |
| Region of Enrollment Italy | 3 participants | 1 participants | 4 participants |
| Region of Enrollment Poland | 8 participants | 9 participants | 17 participants |
| Region of Enrollment Spain | 5 participants | 7 participants | 12 participants |
| Region of Enrollment Sweden | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 30 Participants | 31 Participants | 61 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 30 | 17 / 31 |
| serious Total, serious adverse events | 2 / 30 | 0 / 31 |
Outcome results
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | -1.1148 Percent Change | Standard Error 1.94506 |
| Risedronate | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 3.2192 Percent Change | Standard Error 3.55882 |
Primary
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).
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population | -0.2530 Percent Change | Standard Error 1.83321 |
| Risedronate | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population | 3.2192 Percent Change | Standard Error 3.55882 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population | -1.0384 Percent Change | Standard Error 2.19722 |
| Risedronate | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population | 1.4797 Percent Change | Standard Error 1.03811 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 1.4058 Percent Change | Standard Error 1.42232 |
| Risedronate | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 2.2334 Percent Change | Standard Error 1.375 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population | 1.9561 Percent Change | Standard Error 1.37883 |
| Risedronate | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population | 2.2334 Percent Change | Standard Error 1.375 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population | 1.6386 Percent Change | Standard Error 1.39295 |
| Risedronate | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population | 4.4060 Percent Change | Standard Error 1.5442 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 5.5312 Percent Change | Standard Error 1.66394 |
| Risedronate | Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 13.3472 Percent Change | Standard Error 2.09761 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population | 5.5312 Percent Change | Standard Error 1.66394 |
| Risedronate | Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population | 13.3472 Percent Change | Standard Error 2.09761 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population | 6.2217 Percent Change | Standard Error 1.82459 |
| Risedronate | Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population | 12.7784 Percent Change | Standard Error 2.09663 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | -3.2799 Percent Change | Standard Error 1.80579 |
| Risedronate | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 0.6672 Percent Change | Standard Error 0.99708 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population | -2.2999 Percent Change | Standard Error 1.6768 |
| Risedronate | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population | 0.6672 Percent Change | Standard Error 0.99708 |
Primary
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Risedronate | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population | -1.3867 Percent Change | Standard Error 1.98837 |
| Risedronate | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population | 3.3871 Percent Change | Standard Error 0.96971 |