Low Bone Mineral Density, Postmenopausal Osteoporosis
Conditions
Brief summary
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
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.
Interventions
Oral eldecalcitol 0.75μg daily
Oral calcitriol 0.5μg daily
Sponsors
Chugai Pharma China Co., Ltd.
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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
1. 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 2. 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 3. 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 4. Urolithiasis at screening 5. 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) 6. Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure 7. Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained 8. History of allergy to vitamin D 9. Any condition which in the opinion of the investigator unfit for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine | Baseline to 12 months | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline at Month 6 in BMD of the Total Hip | Baseline to 6 months | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. |
| Percent Change From Baseline at Month 6 in BMD of the Femoral Neck | Baseline to 6 months | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. |
| Percent Change From Baseline at Month 12 in BMD of the Total Hip | Baseline to 6 months | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. |
| Percent Change From Baseline at Month 12 in BMD of the Femoral Neck | Baseline to 12 months | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. |
| Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine | Baseline to 6 months | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. |
| Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) | Baseline and months 6 and 12 | Serum CTX will be determined |
| Percent Change From Baseline in Parathyroid Hormone (PTH) | Baseline and months 6 and 12 | Serum PTH will be determined |
| Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D] | Baseline and months 6 and 12 | Serum 25(OH)D will be determined |
| Incidence of new vertebral fracture | Baseline and months 12 | New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae |
| Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) | Baseline and months 6 and 12 | Serum P1NP will be determined |
Countries
China
Contacts
Primary ContactLi Shen
Outcome results
None listed