Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

Conditions
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Low Bone Mineral Density, Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Eldecalcitol capsules
* Drug: Calcitriol capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years of age and older will be considered postmenopausal. BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening: 1) low BMD: -2.5<T< -1.0, without vertebral and fragility fracture history 2) mild osteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatory outpatients 4. Written informed consent Exclusion Criteria: Severe vitamin D deficiency at screening (defined as serum 25OHD<10 ng/ml);Vitamin D repletion will be permitted and dosage will be at the discretion of investigators and subjects may be re-screened Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c>9%), or other conditions that can cause secondary osteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate oral for 6 months or more in the 3 years prior to study entry; or had received parathyroid hormone once or more in the 3 years before entering the study; or received 2 weeks or more of calcitonin or vitamin K or active vitamin D or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for bone pine within 2 months prior to study entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry Urolithiasis at screening Hypercalcemia (serum calcium >10.4 mg/dL), or hypercalciuria (urine calcium>400 mg/gCr), or hyperuricemia (above 420 μmol/L in men and 360 μmol/L in women) Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained History of allergy to vitamin D Any condition which in the opinion of the investigator unfit for the study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eldecalcitol<br>Participants receive oral eldecalcitol 0.75μg daily for 12 months | Drug: Eldecalcitol capsules<br>* Oral eldecalcitol 0.75μg daily<br>* Other names: Edirol;|
| Active Comparator: Calcitriol<br>Participants receive oral calcitriol 0.5μg daily for 12 months | Drug: Calcitriol capsules<br>* Oral calcitriol 0.5μg daily<br>* Other names: Haidewei;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent 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. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Baseline to 12 months | 
| Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) | Serum P1NP will be determined | Baseline and months 6 and 12 | 
| Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) | Serum CTX will be determined | Baseline and months 6 and 12 | 
| Percent Change From Baseline in Parathyroid Hormone (PTH) | Serum PTH will be determined | Baseline and months 6 and 12 | 
| Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D] | Serum 25(OH)D will be determined | 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 | Baseline and months 12 |