Osteoporosis
Conditions
Brief summary
The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients. This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.
Interventions
DRUGTeriparatide
Administered subcutaneously during the Treatment Period
DRUGAspara-CA 600 mg
Administered orally throughout the study
DRUGAlfarol 1.0 µg
Administered orally throughout the study
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria
Exclusion criteria
* Prior treatment with parathyroid hormone (PTH) or any PTH analog * History of metabolic bone disorders other than primary osteoporosis * Fractures caused by diseases other than osteoporosis * Abnormal thyroid function * Hyperparathyroidism or hypoparathyroidism * Severe or chronically disabling conditions other than osteoporosis * Currently has or has a history of spruce, inflammatory bowel disease, or malabsorption syndrome * Currently has, or a has a history of, nephrolithiasis or urolithiasis in the 2 years prior to screening * Clinically significant abnormal laboratory values or electrocardiogram * Treatment with oral bisphosphonates at any time in the 3 months prior to enrollment, treatment with any bisphosphonate for more than 60 days in the 6 months prior to enrollment, or with intravenous bisphosphonates at any time in the 24 months prior to enrollment; or in case of oral bisphosphonates administered once a week, the equivalent as the above * Treatment with injectable calcitonin in the 3 months prior to enrollment * Treatment with raloxifene hydrochloride for more than 3 months in the 6 months prior to enrollment * Treatment with systemic corticosteroids, except for orally inhaled or nasally inhaled corticosteroids, in doses \<= 800 micrograms per day (µg/day) beclomethasone dipropionate or equivalent in the 3 months prior to screening, or for more than 30 days in the 12 months prior to enrollment * Treatment with anticonvulsants, except for benzodiazepines, in the 6 months prior to enrollment * Prior treatment with strontiumranate or denosumab (anti-RANKL antibody) * Prior external beam radiation therapy involving the skeleton * Current or a history of malignant neoplasm in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that had been definitively treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) | Day 28 (16 and 24 hours postdose) | Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Postdose refers to after Teriparatide dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline | Day 1 up to Day 28 (Teriparatide Treatment Period) | Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period. |
| Mean Serum Calcium Levels | Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) | Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter \[mg/dL\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day\*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose). |
| Change From Baseline in Serum Calcium | Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) | Corrected calcium (milligram per deciliter \[mg/dL\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). The Least Squares (LS) means were controlled for Day, Timepoint, Day\*Timepoint, and random error. Postdose refers to after Teriparatide dose. |
| Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline | Day 1 up to Day 28 (28-day Teriparatide Treatment Period) | Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period. |
| Mean Daily Urine Calcium Excreted | Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period) | — |
| Change From Baseline in Daily Urine Calcium Excreted | Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period) | — |
| Concentrations of Serum 25-Hydroxy-Vitamin D | Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) | — |
| Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide Aspara-CA (600 milligrams \[mg\]) and Alfarol (1.0 microgram \[µg\]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 28-Day Teriparatide Treatment Period | Adverse Event | 1 |
Baseline characteristics
| Characteristic | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide |
|---|---|
| Age Continuous | 70 years STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Mean Urine Calcium Excreted | 0.12 grams per day (g/day) STANDARD_DEVIATION 0.05 |
| Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day) Urine calcium excreted ≤0.3 g/day | 29 participants |
| Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day) Urine calcium excreted >0.3 g/day | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 29 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 29 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Postdose refers to after Teriparatide dose.
Time frame: Day 28 (16 and 24 hours postdose)
Population: All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) | 16 hours postdose | 0 participants | 0 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) | 24 hours postdose | 0 participants | — |
Secondary
Change From Baseline in Daily Urine Calcium Excreted
Time frame: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)
Population: All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Daily Urine Calcium Excreted | Change from Baseline at Day 1 | 0.01 grams per day (g/day) | Standard Deviation 0.02 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Daily Urine Calcium Excreted | Change from Baseline at Day 7 (N=27) | 0.02 grams per day (g/day) | Standard Deviation 0.03 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Daily Urine Calcium Excreted | Change from Baseline at Day 14 (N=27) | 0.01 grams per day (g/day) | Standard Deviation 0.04 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Daily Urine Calcium Excreted | Change from Baseline at Day 28 (N=27) | 0.01 grams per day (g/day) | Standard Deviation 0.04 |
Secondary
Change From Baseline in Serum Calcium
Corrected calcium (milligram per deciliter \[mg/dL\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). The Least Squares (LS) means were controlled for Day, Timepoint, Day\*Timepoint, and random error. Postdose refers to after Teriparatide dose.
Time frame: Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)
Population: All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 14: 0 h predose, n=28 | -0.018 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 28: 4 h postdose, n=28 | 0.436 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 28: 6 h postdose, n=28 | 0.404 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 28: 16 h postdose,n=28 | 0.082 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline Day 1: 0 h predose | -0.255 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 1: 2 h postdose | 0.059 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 1: 4 h postdose | 0.183 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 1: 6 h postdose | 0.221 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 1: 16 h postdose | -0.117 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 1: 24 h postdose | -0.038 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 7: 0 h predose, n=28 | 0.018 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 7: 2 h postdose, n=28 | 0.286 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 7: 4 h postdose, n=28 | 0.450 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 7: 6 h postdose, n=28 | 0.436 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 7: 16 h postdose, n=28 | 0.061 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 7: 24 h postdose, n=28 | 0.068 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 14: 2 h postdose, n=28 | 0.232 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 14: 4 h postdose, n=28 | 0.404 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 14: 6 h postdose, n=28 | 0.368 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 14: 16 h postdose,n=28 | 0.068 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 14: 24 h postdose,n=28 | 0.143 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 28: 0 h predose, n=28 | -0.021 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 28: 2 h postdose, n=28 | 0.286 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Change From Baseline in Serum Calcium | Change from Baseline at Day 28: 24 h postdose,n=28 | 0.104 mg/dL |
Secondary
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Time frame: Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)
Population: All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 1 | 54.0 picogram per milliliter (pg/mL) | Standard Deviation 16.9 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 8 (N=28) | 105.3 picogram per milliliter (pg/mL) | Standard Deviation 35.2 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 15 (N=28) | 108.5 picogram per milliliter (pg/mL) | Standard Deviation 40.2 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 29 (N=28) | 98.1 picogram per milliliter (pg/mL) | Standard Deviation 32 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 35 (N=28) | 53.9 picogram per milliliter (pg/mL) | Standard Deviation 22.3 |
Secondary
Concentrations of Serum 25-Hydroxy-Vitamin D
Time frame: Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)
Population: All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 25-Hydroxy-Vitamin D | Day 1 | 23.0 nanogram per milliliter (ng/mL) | Standard Deviation 5.4 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 25-Hydroxy-Vitamin D | Day 8 (N=28) | 22.1 nanogram per milliliter (ng/mL) | Standard Deviation 6.2 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 25-Hydroxy-Vitamin D | Day 15 (N=28) | 21.5 nanogram per milliliter (ng/mL) | Standard Deviation 6.6 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 25-Hydroxy-Vitamin D | Day 29 (N=28) | 20.1 nanogram per milliliter (ng/mL) | Standard Deviation 8 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Concentrations of Serum 25-Hydroxy-Vitamin D | Day 35 (N=28) | 21.6 nanogram per milliliter (ng/mL) | Standard Deviation 7.2 |
Secondary
Mean Daily Urine Calcium Excreted
Time frame: Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)
Population: All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Daily Urine Calcium Excreted | Day 1 | 0.13 grams per day (g/day) | Standard Deviation 0.05 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Daily Urine Calcium Excreted | Day 7 (N=27) | 0.14 grams per day (g/day) | Standard Deviation 0.05 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Daily Urine Calcium Excreted | Day 14 (N=27) | 0.13 grams per day (g/day) | Standard Deviation 0.05 |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Daily Urine Calcium Excreted | Day 28 (N=27) | 0.13 grams per day (g/day) | Standard Deviation 0.05 |
Secondary
Mean Serum Calcium Levels
Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter \[mg/dL\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day\*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).
Time frame: Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)
Population: All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Baseline: 2 h postdose | 9.11 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Baseline: 0 h predose | 9.00 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Baseline: 4 h postdose | 8.98 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Baseline: 6 h postdose | 8.92 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Baseline: 16 h postdose | 8.97 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Baseline: 24 h postdose | 8.74 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 1: 0 h predose | 8.74 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 1: 2 h postdose | 9.17 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 1: 4 h postdose | 9.16 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 1: 6 h postdose | 9.14 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 1: 16 h postdose | 8.85 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 1: 24 h postdose | 8.70 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 7: 0 h predose (n=28) | 9.02 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 7: 2 h postdose (n=28) | 9.41 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 14: 0 h predose (n=28) | 8.99 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 14: 4 h postdose (n=28) | 9.39 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 28: 4 h postdose (n=28) | 9.42 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 7: 4 h postdose (n=28) | 9.43 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 7: 6 h postdose (n=28) | 9.36 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 7: 16 h postdose (n=28) | 9.02 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 7: 24 h postdose (n=28) | 8.82 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 14: 16 h postdose (n=28) | 9.03 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 14: 24 h postdose (n=28) | 8.89 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 28: 0 h predose (n=28) | 8.98 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 28: 2 h postdose (n=28) | 9.41 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 28: 6 h postdose (n=28) | 9.33 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 28: 16 h postdose (n=28) | 9.04 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 28: 24 h postdose (n=28) | 8.85 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 14: 2 h postdose (n=28) | 9.35 mg/dL |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Mean Serum Calcium Levels | Day 14: 6 h postdose (n=28) | 9.29 mg/dL |
Secondary
Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline
Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.
Time frame: Day 1 up to Day 28 (28-day Teriparatide Treatment Period)
Population: All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline | 0 participants |
Secondary
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.
Time frame: Day 1 up to Day 28 (Teriparatide Treatment Period)
Population: All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline | Serum Calcium > 11.0 mg/dL | 0 participants |
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline | Serum Calcium > 13.5 mg/dL | 0 participants |