To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.
Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75μg eldecalcit daily or open-label oral 0.5μg calcitriol daily for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Oral eldecalcitol 0.75μg daily
Oral calcitriol 0.5μg daily
The Second Xiangya Hospital of Central South University
Changsha, China
COMPLETEDPercent Change From Baseline at Month 12 in BMD at the Lumbar Spine
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time frame: Baseline to 12 months
Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Total Hip
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Total Hip
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time frame: Baseline to 12 months
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Hangzhou, China
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Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Serum P1NP will be determined
Time frame: Baseline and months 6 and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Serum CTX will be determined
Time frame: Baseline and months 6 and 12
Percent Change From Baseline in Parathyroid Hormone (PTH)
Serum PTH will be determined
Time frame: Baseline and months 6 and 12
Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D]
Serum 25(OH)D will be determined
Time frame: Baseline and months 6 and 12
Incidence of new vertebral fracture
New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae
Time frame: Baseline and months 12