Osteopenia
Conditions
Keywords
Postmenopausal osteoporosis, osteopenia, zoledronic acid, Osteopenia (osteoporosis prevention)
Brief summary
Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.
Interventions
DRUGZoledronic Acid
Zoledronic acid 5 mg intravenous
DRUGPlacebo
Physiologic 0.9% normal saline
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal * Greater than or equal to 45 years of age * Osteopenia (lumbar spine bone mineral density \[BMD\] T-score between -1.0 and -2.5, and BMD T-score \> -2.5 at the femoral neck)
Exclusion criteria
* Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate) * Patients with any Grade 2 or 3 vertebral fracture (as per Genant method) * Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | Baseline, Month 24 | The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | Baseline, Month 24 | The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline). |
| Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | Baseline, Month 24 | The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline). |
| Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Months 6, 12, 18 and 24 | Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum. |
| Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Months 6, 12, 18 and 24 | Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum. |
| Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Months 6, 12, 18 and 24 | Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum. |
Countries
United States
Participant flow
Pre-assignment details
Eligible patients were stratified according to their duration of menopause (those less than 5 years from menopause were included in Stratum I, while those 5 or more years from menopause were included in Stratum II), and randomized equally to one of the three treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Zoledronic Acid 2x5 mg Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 | 198 |
| Zoledronic Acid 1x5 mg Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12 | 181 |
| Placebo Placebo given at randomization and Month 12 | 202 |
| Total | 581 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Stratum I | Abnormal test procedure result (s) | 0 | 0 | 1 |
| Stratum I | Adverse Event | 2 | 1 | 0 |
| Stratum I | Lost to Follow-up | 3 | 4 | 1 |
| Stratum I | Withdrawal by Subject | 4 | 7 | 3 |
| Stratum II | Adverse Event | 1 | 2 | 1 |
| Stratum II | Death | 1 | 0 | 0 |
| Stratum II | Lost to Follow-up | 2 | 2 | 1 |
| Stratum II | Protocol Violation | 0 | 2 | 1 |
| Stratum II | Withdrawal by Subject | 4 | 9 | 6 |
Baseline characteristics
| Characteristic | Total | Zoledronic Acid 2x5 mg | Zoledronic Acid 1x5 mg | Placebo |
|---|---|---|---|---|
| Age, Continuous Stratum II (Women >= 5 Years From Menopause) | 63.8 years STANDARD_DEVIATION 7.34 | 63.9 years STANDARD_DEVIATION 6.62 | 63.4 years STANDARD_DEVIATION 7.74 | 64.2 years STANDARD_DEVIATION 7.65 |
| Age, Continuous Stratum I (Women < 5 Years From Menopause) | 53.9 years STANDARD_DEVIATION 3.68 | 53.6 years STANDARD_DEVIATION 3.62 | 53.7 years STANDARD_DEVIATION 3.59 | 54.4 years STANDARD_DEVIATION 3.83 |
| Sex: Female, Male Female | 581 Participants | 198 Participants | 181 Participants | 202 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 177 / 198 | 158 / 181 | 160 / 202 |
| serious Total, serious adverse events | 21 / 198 | 17 / 181 | 23 / 202 |
Outcome results
Primary
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).
Time frame: Baseline, Month 24
Population: Intent to treat population. Last observation carried forward (LOCF) was utilized to impute missing data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid 2x5 mg | Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | Stratum I (Women < 5 Years From Menopause) | 4.62 Percentage change in BMD | Standard Error 0.444 |
| Zoledronic Acid 2x5 mg | Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | Stratum II (Women >= 5 Years From Menopause) | 5.60 Percentage change in BMD | Standard Error 0.343 |
| Zoledronic Acid 1x5 mg | Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | Stratum I (Women < 5 Years From Menopause) | 4.03 Percentage change in BMD | Standard Error 0.444 |
| Zoledronic Acid 1x5 mg | Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | Stratum II (Women >= 5 Years From Menopause) | 4.76 Percentage change in BMD | Standard Error 0.356 |
| Placebo | Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | Stratum I (Women < 5 Years From Menopause) | -2.24 Percentage change in BMD | Standard Error 0.428 |
| Placebo | Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | Stratum II (Women >= 5 Years From Menopause) | -0.65 Percentage change in BMD | Standard Error 0.339 |
Secondary
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.
Time frame: Months 6, 12, 18 and 24
Population: Intent to treat population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 6 | 8.718 ng/mL | Standard Deviation 2.5827 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 12 | 9.945 ng/mL | Standard Deviation 2.9027 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 18 | 8.365 ng/mL | Standard Deviation 2.5574 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 24 | 9.799 ng/mL | Standard Deviation 2.5836 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 6 | 8.219 ng/mL | Standard Deviation 2.8126 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 12 | 9.678 ng/mL | Standard Deviation 3.0216 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 18 | 8.357 ng/mL | Standard Deviation 2.2152 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 24 | 9.730 ng/mL | Standard Deviation 2.7591 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 18 | 11.233 ng/mL | Standard Deviation 3.1563 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 18 | 10.023 ng/mL | Standard Deviation 2.8237 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 24 | 11.764 ng/mL | Standard Deviation 3.8401 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 6 | 7.925 ng/mL | Standard Deviation 2.2847 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 12 | 9.139 ng/mL | Standard Deviation 2.4558 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 6 | 8.841 ng/mL | Standard Deviation 2.2434 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 12 | 10.539 ng/mL | Standard Deviation 2.98 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 24 | 10.916 ng/mL | Standard Deviation 3.5878 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 18 | 14.149 ng/mL | Standard Deviation 4.8878 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 12 | 14.127 ng/mL | Standard Deviation 4.8981 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 6 | 13.982 ng/mL | Standard Deviation 4.7106 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum I - Month 24 | 14.353 ng/mL | Standard Deviation 4.9089 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 18 | 13.222 ng/mL | Standard Deviation 4.9167 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 12 | 13.650 ng/mL | Standard Deviation 4.8295 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 6 | 13.394 ng/mL | Standard Deviation 5.2169 |
| Placebo | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Stratum II - Month 24 | 13.902 ng/mL | Standard Deviation 4.6302 |
Secondary
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.
Time frame: Months 6, 12, 18 and 24
Population: Intent to treat population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 6 | 20.851 ng/mL | Standard Deviation 9.7724 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 12 | 28.231 ng/mL | Standard Deviation 12.3748 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 18 | 20.102 ng/mL | Standard Deviation 12.6635 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 24 | 28.288 ng/mL | Standard Deviation 12.2706 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 6 | 19.369 ng/mL | Standard Deviation 14.1819 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 12 | 28.333 ng/mL | Standard Deviation 15.8193 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 18 | 19.031 ng/mL | Standard Deviation 14.827 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 24 | 26.211 ng/mL | Standard Deviation 11.8566 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 18 | 35.561 ng/mL | Standard Deviation 14.1588 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 18 | 29.569 ng/mL | Standard Deviation 14.7631 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 24 | 38.743 ng/mL | Standard Deviation 14.7626 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 6 | 19.423 ng/mL | Standard Deviation 16.6028 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 12 | 26.363 ng/mL | Standard Deviation 13.1112 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 6 | 20.752 ng/mL | Standard Deviation 9.756 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 12 | 30.500 ng/mL | Standard Deviation 14.8217 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 24 | 34.418 ng/mL | Standard Deviation 15.4474 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 18 | 55.775 ng/mL | Standard Deviation 19.8842 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 12 | 55.166 ng/mL | Standard Deviation 20.5274 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 6 | 59.449 ng/mL | Standard Deviation 20.3291 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum I - Month 24 | 56.315 ng/mL | Standard Deviation 20.3715 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 18 | 46.943 ng/mL | Standard Deviation 18.8147 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 12 | 49.581 ng/mL | Standard Deviation 20.6559 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 6 | 50.271 ng/mL | Standard Deviation 22.6624 |
| Placebo | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Stratum II - Month 24 | 51.621 ng/mL | Standard Deviation 20.9281 |
Secondary
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.
Time frame: Months 6, 12, 18 and 24
Population: Intent to treat population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 6 | 0.2217 ng/mL | Standard Deviation 0.11791 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 12 | 0.2861 ng/mL | Standard Deviation 0.13776 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 18 | 0.2187 ng/mL | Standard Deviation 0.16812 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 24 | 0.2864 ng/mL | Standard Deviation 0.12242 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 6 | 0.1918 ng/mL | Standard Deviation 0.12648 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 12 | 0.2696 ng/mL | Standard Deviation 0.18247 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 18 | 0.1986 ng/mL | Standard Deviation 0.149 |
| Zoledronic Acid 2x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 24 | 0.2554 ng/mL | Standard Deviation 0.17049 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 18 | 0.3605 ng/mL | Standard Deviation 0.14847 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 18 | 0.2854 ng/mL | Standard Deviation 0.14391 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 24 | 0.3777 ng/mL | Standard Deviation 0.14943 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 6 | 0.1888 ng/mL | Standard Deviation 0.10625 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 12 | 0.2484 ng/mL | Standard Deviation 0.11435 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 6 | 0.2286 ng/mL | Standard Deviation 0.0963 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 12 | 0.3111 ng/mL | Standard Deviation 0.13195 |
| Zoledronic Acid 1x5 mg | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 24 | 0.3254 ng/mL | Standard Deviation 0.1526 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 18 | 0.6444 ng/mL | Standard Deviation 0.28254 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 12 | 0.6634 ng/mL | Standard Deviation 0.25433 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 6 | 0.6439 ng/mL | Standard Deviation 0.27902 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum I - Month 24 | 0.6640 ng/mL | Standard Deviation 0.27538 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 18 | 0.5742 ng/mL | Standard Deviation 0.24399 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 12 | 0.5634 ng/mL | Standard Deviation 0.23442 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 6 | 0.5802 ng/mL | Standard Deviation 0.25034 |
| Placebo | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Stratum II - Month 24 | 0.6012 ng/mL | Standard Deviation 0.26942 |
Secondary
Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.
The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).
Time frame: Baseline, Month 24
Population: Intent to treat population with available data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid 2x5 mg | Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | Stratum I (Women < 5 Years From Menopause) | 2.04 Percentage change in BMD | Standard Error 0.55 |
| Zoledronic Acid 2x5 mg | Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | Stratum II (Women >= 5 Years From Menopause) | 2.35 Percentage change in BMD | Standard Error 0.344 |
| Zoledronic Acid 1x5 mg | Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | Stratum I (Women < 5 Years From Menopause) | 2.01 Percentage change in BMD | Standard Error 0.549 |
| Zoledronic Acid 1x5 mg | Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | Stratum II (Women >= 5 Years From Menopause) | 1.46 Percentage change in BMD | Standard Error 0.366 |
| Placebo | Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | Stratum I (Women < 5 Years From Menopause) | -1.55 Percentage change in BMD | Standard Error 0.508 |
| Placebo | Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | Stratum II (Women >= 5 Years From Menopause) | -1.18 Percentage change in BMD | Standard Error 0.343 |
Secondary
Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.
The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).
Time frame: Baseline, Month 24
Population: Intent to treat population with available data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid 2x5 mg | Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | Stratum I (Women < 5 Years From Menopause) | 2.66 Percentage change in BMD | Standard Error 0.318 |
| Zoledronic Acid 2x5 mg | Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | Stratum II (Women >= 5 Years From Menopause) | 3.04 Percentage change in BMD | Standard Error 0.265 |
| Zoledronic Acid 1x5 mg | Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | Stratum I (Women < 5 Years From Menopause) | 2.55 Percentage change in BMD | Standard Error 0.317 |
| Zoledronic Acid 1x5 mg | Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | Stratum II (Women >= 5 Years From Menopause) | 2.11 Percentage change in BMD | Standard Error 0.282 |
| Placebo | Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | Stratum I (Women < 5 Years From Menopause) | -2.10 Percentage change in BMD | Standard Error 0.293 |
| Placebo | Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | Stratum II (Women >= 5 Years From Menopause) | -1.04 Percentage change in BMD | Standard Error 0.265 |