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

Launched by SHANGHAI JIAO TONG UNIVERSITY AFFILIATED SIXTH PEOPLE'S HOSPITAL · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called eldecalcitol compared to calcitriol in postmenopausal women who have low bone mineral density or mild osteoporosis. The aim is to see if eldecalcitol can help improve bone health in women aged 50 and older who have been postmenopausal for more than two years. To join the study, participants need to have a specific bone density measurement, which indicates either low bone density or mild osteoporosis, and they must be able to walk independently.

Women interested in participating can expect to be part of a study where they will receive one of the two medications and will be monitored for their bone health over time. It's important to know that there are some health conditions that would make someone ineligible for the trial, such as severe vitamin D deficiency or certain types of serious diseases. Participants will need to provide written consent to join the study and will be recruited at various locations. This trial is currently looking for volunteers!

Gender

FEMALE

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