Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B3D-JE-GHDT | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide + Aspara-CA + Alfarol | Experimental | Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Administered subcutaneously during the Treatment Period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 (16 and 24 hours postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | Japan |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 14-Day Lead-In Period |
| |||||||||||||
| 28-Day Teriparatide Treatment Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | Day 28 (16 and 24 hours postdose) |
|
Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aspara-CA 600 mg | Drug | Administered orally throughout the study |
|
| Alfarol 1.0 µg | Drug | Administered orally throughout the study |
|
| Day 1 up to Day 28 (Teriparatide Treatment Period) |
| 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). | 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) |
| 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. | 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) |
| 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. | Day 1 up to Day 28 (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) |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day) | Baseline calcium measures were assessed over a 24-hour period on the last day of the 14-day Lead-in Period (Day -1), after participants had been receiving Aspara-CA and Alfarol supplements, to determine the total urine calcium excreted per day. | Number | participants |
|
| Mean Urine Calcium Excreted | Baseline calcium measures were assessed on the last day of the 14-day Lead-in Period (Day -1), after participants had been receiving Aspara-CA and Alfarol supplements. One participant was excluded from the analysis because the participant accidentally dropped the urine collection sample during baseline (N=28). | Mean | Standard Deviation | grams per day (g/day) |
|
|
|
| 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. | 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. | Posted | Number | participants | Day 1 up to Day 28 (Teriparatide Treatment Period) |
|
|
|
| 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). | 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. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | 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) |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | 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) |
|
|
|
| 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. | 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. | Posted | Number | participants | Day 1 up to Day 28 (28-day Teriparatide Treatment Period) |
|
|
|
| Secondary | Mean Daily Urine Calcium Excreted | 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. | Posted | Mean | Standard Deviation | grams per day (g/day) | Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period) |
|
|
|
| Secondary | Change From Baseline in Daily Urine Calcium Excreted | 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. | Posted | Mean | Standard Deviation | grams per day (g/day) | Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period) |
|
|
|
| Secondary | Concentrations of Serum 25-Hydroxy-Vitamin D | 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. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 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) |
|
|
|
| Secondary | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | 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. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | 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) |
|
|
|
| 0 |
| 29 |
| 5 |
| 29 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| Baseline: 6 h postdose |
|
| Baseline: 16 h postdose |
|
| Baseline: 24 h postdose |
|
| Day 1: 0 h predose |
|
| Day 1: 2 h postdose |
|
| Day 1: 4 h postdose |
|
| Day 1: 6 h postdose |
|
| Day 1: 16 h postdose |
|
| Day 1: 24 h postdose |
|
| Day 7: 0 h predose (n=28) |
|
| Day 7: 2 h postdose (n=28) |
|
| Day 7: 4 h postdose (n=28) |
|
| Day 7: 6 h postdose (n=28) |
|
| Day 7: 16 h postdose (n=28) |
|
| Day 7: 24 h postdose (n=28) |
|
| Day 14: 0 h predose (n=28) |
|
| Day 14: 2 h postdose (n=28) |
|
| Day 14: 4 h postdose (n=28) |
|
| Day 14: 6 h postdose (n=28) |
|
| Day 14: 16 h postdose (n=28) |
|
| Day 14: 24 h postdose (n=28) |
|
| Day 28: 0 h predose (n=28) |
|
| Day 28: 2 h postdose (n=28) |
|
| Day 28: 4 h postdose (n=28) |
|
| Day 28: 6 h postdose (n=28) |
|
| Day 28: 16 h postdose (n=28) |
|
| Day 28: 24 h postdose (n=28) |
|
|
| Change from Baseline at Day 1: 6 h postdose |
|
| Change from Baseline at Day 1: 16 h postdose |
|
| Change from Baseline at Day 1: 24 h postdose |
|
| Change from Baseline at Day 7: 0 h predose, n=28 |
|
| Change from Baseline at Day 7: 2 h postdose, n=28 |
|
| Change from Baseline at Day 7: 4 h postdose, n=28 |
|
| Change from Baseline at Day 7: 6 h postdose, n=28 |
|
| Change from Baseline at Day 7: 16 h postdose, n=28 |
|
| Change from Baseline at Day 7: 24 h postdose, n=28 |
|
| Change from Baseline at Day 14: 0 h predose, n=28 |
|
| Change from Baseline at Day 14: 2 h postdose, n=28 |
|
| Change from Baseline at Day 14: 4 h postdose, n=28 |
|
| Change from Baseline at Day 14: 6 h postdose, n=28 |
|
| Change from Baseline at Day 14: 16 h postdose,n=28 |
|
| Change from Baseline at Day 14: 24 h postdose,n=28 |
|
| Change from Baseline at Day 28: 0 h predose, n=28 |
|
| Change from Baseline at Day 28: 2 h postdose, n=28 |
|
| Change from Baseline at Day 28: 4 h postdose, n=28 |
|
| Change from Baseline at Day 28: 6 h postdose, n=28 |
|
| Change from Baseline at Day 28: 16 h postdose,n=28 |
|
| Change from Baseline at Day 28: 24 h postdose,n=28 |
|
| Title | Measurements |
|---|---|
|
| Day 28 (N=27) |
|
|
| Change from Baseline at Day 28 (N=27) |
|
| Title | Measurements |
|---|---|
|
| Day 29 (N=28) |
|
| Day 35 (N=28) |
|
| Title | Measurements |
|---|---|
|
| Day 29 (N=28) |
|
| Day 35 (N=28) |
|