Osteoporosis
Conditions
Keywords
Bone Mineral Density (BMD), C-Telopeptides (CTx), dual x-ray absorptiometry (DXA), pro-collagen type 1 N-propeptide (P1NP), teriparatide, zoledronic acid, Osteoporosis, postmenopausal women
Brief summary
The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip
Interventions
DRUGZoledronic acid
Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid.
DRUGPlacebo
Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to allow an infusion of 100 mL total volume in a ready-to-infuse plastic bottle
DRUGTeriparatide
Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each pre-filled delivery device is filled with 3.3 mL to deliver 3 mL. Each mL contains 250 μg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetate acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge pre-assembled into a pen device delivers 20 μg of teriparatide per dose each day for up to 28 days.
Sponsors
Novartis
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 89 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal (PMO) women between 45 and 89 years of age. * Bone mineral density T score of -2.5 or less at femoral neck, total hip or lumbar spine OR * Bone mineral density T score of -2.0 or less at femoral neck, total hip or lumbar spine with at least one documented osteoporotic vertebral fracture or a previously documented history of an osteoporotic clinical non-vertebral fracture not due to excessive trauma
Exclusion criteria
* Any prior use of strontium * Any past or active kidney disease or problems with kidney function * Prior treatment with any intravenous (i.v.) or oral bisphosphonate (such as but not limited to alendronate, risedronate and pamidronate) longer than 3 months consecutively. If bisphosphonate exposure is less than or equal to 3 months , a washout period of 1 year to randomization is required * Calcium levels in blood within the normal range * Normal liver function * Non-osteoporotic forms of metabolic bone disease such as and not limited to Paget's disease of bone, osteomalacia, osteogenesis imperfecta or multiple myeloma * Less than 3 evaluable lumbar (L1-L4) vertebrae for dual energy x-ray absorptiometry (DXA) measurement * Treatment with osteoporotic therapies such as raloxifene, calcitonin or Hormone Replacement Therapy within 3 months of randomization * Allergy or previous exposure to teriparatide Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 | Baseline through Week 52 | BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Baseline through Week 13 and Week 26 | BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation. |
| Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | Baseline through Week 13, Week 26 and Week 52 | BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation. |
| Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52 | Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory. |
| Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52 | Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory. |
Countries
Belgium, Germany, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoledronic Acid Plus Teriparatide Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks. | 137 |
| Zoledronic Acid Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. | 137 |
| Placebo Zoledronic Acid Plus Teriparatide Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks. | 138 |
| Total | 412 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems | 1 | 0 | 0 |
| Overall Study | Adverse Event | 5 | 2 | 3 |
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 2 |
Baseline characteristics
| Characteristic | Zoledronic Acid Plus Teriparatide | Zoledronic Acid | Placebo Zoledronic Acid Plus Teriparatide | Total |
|---|---|---|---|---|
| Age Continuous | 65.0 years STANDARD_DEVIATION 8.78 | 66.1 years STANDARD_DEVIATION 9.02 | 63.8 years STANDARD_DEVIATION 9.08 | 65.0 years STANDARD_DEVIATION 8.99 |
| Sex: Female, Male Female | 137 Participants | 137 Participants | 138 Participants | 412 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 | 115 / 137 | 118 / 137 | 96 / 137 |
| serious Total, serious adverse events | 20 / 137 | 13 / 137 | 15 / 137 |
Outcome results
Primary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.
Time frame: Baseline through Week 52
Population: The intent-to-treat (ITT) population consisted of all randomized patients with available data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 | 7.51 Percent change | Standard Error 0.414 |
| Zoledronic Acid | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 | 4.37 Percent change | Standard Error 0.401 |
| Placebo Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 | 7.05 Percent change | Standard Error 0.398 |
Secondary
Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)
Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory.
Time frame: At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
Population: The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Baseline (n= 126, 129, 121) | 0.45 ng/mL | Standard Deviation 0.191 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 4 (n= 109, 110, 104) | 0.05 ng/mL | Standard Deviation 0.048 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 8 (n= 106, 107, 98) | 0.09 ng/mL | Standard Deviation 0.109 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 26 (n= 116, 119, 114) | 0.43 ng/mL | Standard Deviation 0.419 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 39 (n= 110, 115, 110) | 0.57 ng/mL | Standard Deviation 0.525 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 52 (n= 110, 113, 112) | 0.64 ng/mL | Standard Deviation 0.476 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 52 (n= 110, 113, 112) | 0.17 ng/mL | Standard Deviation 0.122 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Baseline (n= 126, 129, 121) | 0.44 ng/mL | Standard Deviation 0.218 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 26 (n= 116, 119, 114) | 0.12 ng/mL | Standard Deviation 0.117 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 39 (n= 110, 115, 110) | 0.15 ng/mL | Standard Deviation 0.108 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 4 (n= 109, 110, 104) | 0.05 ng/mL | Standard Deviation 0.059 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 8 (n= 106, 107, 98) | 0.07 ng/mL | Standard Deviation 0.112 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 4 (n= 109, 110, 104) | 0.45 ng/mL | Standard Deviation 0.259 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 8 (n= 106, 107, 98) | 0.60 ng/mL | Standard Deviation 0.32 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 52 (n= 110, 113, 112) | 0.83 ng/mL | Standard Deviation 0.393 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 26 (n= 116, 119, 114) | 0.90 ng/mL | Standard Deviation 0.537 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Baseline (n= 126, 129, 121) | 0.46 ng/mL | Standard Deviation 0.222 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Week 39 (n= 110, 115, 110) | 0.89 ng/mL | Standard Deviation 0.503 |
Secondary
Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)
Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory.
Time frame: At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
Population: The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Baseline (n= 126, 129, 121) | 52.72 ng/mL | Standard Deviation 24.815 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 4 (n= 109, 110, 104) | 61.74 ng/mL | Standard Deviation 27.269 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 8 (n= 106, 107, 98) | 39.91 ng/mL | Standard Deviation 22.412 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 26 (n= 116, 119, 114) | 65.26 ng/mL | Standard Deviation 68.922 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 39 (n= 110, 115, 110) | 97.00 ng/mL | Standard Deviation 112.804 |
| Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 52 (n= 110, 113, 112) | 112.87 ng/mL | Standard Deviation 106.987 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 52 (n= 110, 113, 112) | 23.49 ng/mL | Standard Deviation 16.137 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Baseline (n= 126, 129, 121) | 53.64 ng/mL | Standard Deviation 29.233 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 26 (n= 116, 119, 114) | 18.32 ng/mL | Standard Deviation 15.255 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 39 (n= 110, 115, 110) | 20.69 ng/mL | Standard Deviation 13.326 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 4 (n= 109, 110, 104) | 39.57 ng/mL | Standard Deviation 20.532 |
| Zoledronic Acid | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 8 (n= 106, 107, 98) | 21.68 ng/mL | Standard Deviation 13.827 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 4 (n= 109, 110, 104) | 93.63 ng/mL | Standard Deviation 52.418 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 8 (n= 106, 107, 98) | 99.27 ng/mL | Standard Deviation 48.404 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 52 (n= 110, 113, 112) | 137.53 ng/mL | Standard Deviation 93.17 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 26 (n= 116, 119, 114) | 156.97 ng/mL | Standard Deviation 109.74 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Baseline (n= 126, 129, 121) | 55.69 ng/mL | Standard Deviation 28.631 |
| Placebo Zoledronic Acid Plus Teriparatide | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Week 39 (n= 110, 115, 110) | 153.92 ng/mL | Standard Deviation 103.065 |
Secondary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26
BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.
Time frame: Baseline through Week 13 and Week 26
Population: The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | At Week 13 (n= 127, 131, 131) | 4.65 Percent Change | Standard Error 0.302 |
| Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | At Week 26 (n= 128, 130, 132) | 6.31 Percent Change | Standard Error 0.337 |
| Zoledronic Acid | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | At Week 13 (n= 127, 131, 131) | 2.97 Percent Change | Standard Error 0.297 |
| Zoledronic Acid | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | At Week 26 (n= 128, 130, 132) | 3.87 Percent Change | Standard Error 0.333 |
| Placebo Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | At Week 13 (n= 127, 131, 131) | 2.88 Percent Change | Standard Error 0.297 |
| Placebo Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | At Week 26 (n= 128, 130, 132) | 4.45 Percent Change | Standard Error 0.33 |
Secondary
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52
BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.
Time frame: Baseline through Week 13, Week 26 and Week 52
Population: The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 26 (n= 128, 130, 133) | 2.31 Percent Change | Standard Error 0.265 |
| Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 13 (n= 127, 133, 133) | 2.54 Percent Change | Standard Error 0.222 |
| Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 52 (n= 123, 129, 129) | 2.33 Percent Change | Standard Error 0.312 |
| Zoledronic Acid | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 26 (n= 128, 130, 133) | 1.73 Percent Change | Standard Error 0.262 |
| Zoledronic Acid | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 13 (n= 127, 133, 133) | 1.53 Percent Change | Standard Error 0.216 |
| Zoledronic Acid | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 52 (n= 123, 129, 129) | 2.16 Percent Change | Standard Error 0.303 |
| Placebo Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 13 (n= 127, 133, 133) | 0.75 Percent Change | Standard Error 0.216 |
| Placebo Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 52 (n= 123, 129, 129) | 1.10 Percent Change | Standard Error 0.304 |
| Placebo Zoledronic Acid Plus Teriparatide | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | At Week 26 (n= 128, 130, 133) | 0.89 Percent Change | Standard Error 0.259 |