Phase 4
Completed N=30
A Study of Teriparatide in Japanese Osteoporosis Patients
Source: ClinicalTrials.gov NCT01430104 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) — 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) |
0; 0 | — |
| 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 |
0; 0 | — |
| SECONDARY Mean Serum Calcium Levels |
9.00; 9.11; 8.98; 8.92; 8.97; 8.74 | — |
| SECONDARY Change From Baseline in Serum Calcium |
-0.255; 0.059; 0.183; 0.221; -0.117; -0.038 | — |
| SECONDARY Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline |
— | — |
| SECONDARY Mean Daily Urine Calcium Excreted |
0.13; 0.14; 0.13; 0.13 | — |
| SECONDARY Change From Baseline in Daily Urine Calcium Excreted |
0.01; 0.02; 0.01; 0.01 | — |
| SECONDARY Concentrations of Serum 25-Hydroxy-Vitamin D |
23.0; 22.1; 21.5; 20.1; 21.6 | — |
| SECONDARY Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 |
54.0; 105.3; 108.5; 98.1; 53.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01430104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.