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

Postmenopausal Osteoporosis Clinical Trial

— EFFECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902078
• Other study ID #: 2023MDEDR0007
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Low Bone Mineral Density
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

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