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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered subcutaneously during the Treatment Period
Administered orally throughout the study
Administered orally throughout the study
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
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)
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)
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)
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.
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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)
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)
Mean Daily Urine Calcium Excreted
Time frame: Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)
Change From Baseline in Daily Urine Calcium Excreted
Time frame: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)
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)
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)