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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05902078
Other study ID # 2023MDEDR0007
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 27, 2023
Est. completion date December 2025

Study information

Verified date May 2024
Source Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Contact Li Shen
Phone (+86)15800674978
Email shenli_0510@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Eldecalcitol capsules
Oral eldecalcitol 0.75µg daily
Calcitriol capsules
Oral calcitriol 0.5µg daily

Locations

Country Name City State
China The Second Xiangya Hospital of Central South University Changsha
China The Fourth Affiliated Hospital of Harbin Medical University Ha'erbin
China Zhejiang Provincial People's Hospital Hangzhou
China Huai 'an First People's Hospital Huai'an
China Liaocheng People's Hospital Liaocheng
China Jiangxi Provincial People's Hospital Nanchang
China Jiangsu Geriatric Hospital Nanjin
China The First Hospital of Ningbo Ningbo
China The Sixth Hospital of Ningbo Ningbo
China Pingxiang People's Hospital Pingxiang
China Huadong Hospital Affiliated to Fudan University Shanghai
China Shanghai First People's Hospital Shanghai
China Shanghai Pudong New Area Punan Hospital Shanghai
China Shanghai Sixth People's Hospital Shanghai
China Zhongshan Hosiptal Affiliated to Fudan University Shanghai
China The Second Affiliated Hospital of Soochow University Suzhou
China The First Hospital of Shanxi Medical University Taiyuan
China The Second Hospital of Shanxi Medical University Taiyuan
China Tianjin Hospital Tianjin
China Xi'an Honghui Hospital Xi'an
China Xuzhou Central Hospital Xuzhou

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital Chugai Pharma China Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) Serum P1NP will be determined Baseline and months 6 and 12
Secondary Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) Serum CTX will be determined Baseline and months 6 and 12
Secondary Percent Change From Baseline in Parathyroid Hormone (PTH) Serum PTH will be determined Baseline and months 6 and 12
Secondary Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D] Serum 25(OH)D will be determined Baseline and months 6 and 12
Secondary Incidence of new vertebral fracture New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae Baseline and months 12
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