Comparison of the efficacy and safety between eldecalcitol and calcitriol in postmenopausal women with low bone mineral density and mild osteoporosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300070456

Enrollment

Unknown

Registered

2023-04-12

Start date

2023-04-30

Completion date

Unknown

Last updated

2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

Eldecalcitol group:Orally 0.75 µg qd Eldecalcitol

Calcitriol group:Orally 0.5 µg qd Calcitriol

Eligibility

Sex/Gender

Female

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Postmenopausal women over 50 years old who have gone through menopause for more than two years;If the time of menopause is unknown, 60 years or older is sufficient; 2. Bone mineral density was determined by dual-energy X-ray absorptiometry (DXA) during screening, and the bone mineral density at the L1-4 segment of lumbar spine or the whole hip or neck of femur met one of the following conditions: (1) Low bone mass, i.e. -2.5<T value < -1.0, and no history of vertebral fracture or brittleness fracture; (2) Non-severe osteoporosis, i.e., T-score <=-2.5, and no history of vertebral fracture or brittleness fracture; 3. Outpatient patients who can walk; 4. The patient understands the informed consent and voluntarily participates in this experiment. The informed consent has been signed by the patient himself or his legal representative.

Exclusion criteria

Exclusion criteria: 1. Severe deficiency of VD at screening (defined as serum 25OHD 10.4mg/dL) or hypercalcemia (>400 mg/gCr), or creatinine exceeding the center's normal limit, or hyperuricemia (420µmol/L in men and 360µmol/L in women). 6. Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure. 7. Patients with malignant tumor or prior history of malignant tumor within 5 years prior to obtaining informed consent. 8. Patients with a history of allergy to vitamin D preparations. 9. Patients deemed unsuitable as subjects by other investigators.

Design outcomes

Primary

Measure	Time frame
Bone mineral density ;	—

Secondary

Measure	Time frame
Bone turnover markers ;Blood biochemistry;Urine routine;24-hour urine calcium;	—

Countries

China

Contacts

Public ContactZhang Zhenlin

Shanghai Sixth People's Hospital

zzl2002@medmail.com.cn+86 13621673716

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026