A Study of Teriparatide in Japanese Osteoporosis Patients
- Conditions
- Osteoporosis
- Interventions
- Registration Number
- NCT01430104
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Teriparatide + Aspara-CA + Alfarol Aspara-CA 600 mg 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. Teriparatide + Aspara-CA + Alfarol Alfarol 1.0 µg 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. Teriparatide + Aspara-CA + Alfarol Teriparatide 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
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