Clinical trial NCT05902078: Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Official title: Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Low Bone Mineral Density
Postmenopausal Osteoporosis
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
Collaborators: name: Chugai Pharma China Co., Ltd.
First posted: 2023-06-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
timeFrame: Baseline to 6 months
measure: Percent Change From Baseline at Month 6 in BMD of the Total Hip
timeFrame: Baseline to 6 months
measure: Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
timeFrame: Baseline to 6 months
measure: Percent Change From Baseline at Month 12 in BMD of the Total Hip
timeFrame: Baseline to 6 months
measure: Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
timeFrame: Baseline to 12 months
measure: Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
timeFrame: Baseline and months 6 and 12
measure: Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
timeFrame: Baseline and months 6 and 12
measure: Percent Change From Baseline in Parathyroid Hormone (PTH)
timeFrame: Baseline and months 6 and 12
measure: Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D]
timeFrame: Baseline and months 6 and 12
measure: Incidence of new vertebral fracture
timeFrame: Baseline and months 12
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Ha'erbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Huai'an
country: China
facility: Huai 'an First People's Hospital
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanjin
country: China
facility: Jiangsu Geriatric Hospital
city: Ningbo
country: China
facility: The First Hospital of Ningbo
city: Ningbo
country: China
facility: The Sixth Hospital of Ningbo
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Shanghai Pudong New Area Punan Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shanghai
country: China
facility: Zhongshan Hosiptal Affiliated to Fudan University
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
city: Tianjin
country: China
facility: Tianjin Hospital
city: Xi'an
country: China
facility: Xi'an Honghui Hospital
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
Study officials:
affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Zhenlin Zhang
role: PRINCIPAL_INVESTIGATOR
References: