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Efficacy and ADR monitoring of Eldecalcitol in the treatment of postmenopausal and diabetic osteoporosis

Efficacy and ADR monitoring of Eldecalcitol in the treatment of postmenopausal and diabetic osteoporosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066283
Enrollment
Unknown
Registered
2022-11-30
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Osteoporosis

Interventions

Diabetes osteoporosis group:N/A

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Postmenopausal women over the age of 45. Patients with osteoporosis: Those who meet the diagnostic criteria for osteoporosis in the 2017 edition of the Guidelines for Primary Osteoporosis Diagnosis and Treatment meet one of the following three criteria: (1) BMD of the axial bone (lumbar 1-4, femoral neck, or total hip) or the BMD of 1/3 of the distal radius by dual-energy radiography with a T value <=-2.5 (2) previous brittle fractures of the vertebra or hip (3) BMD measurements suggest low bone mass (-2.5 < T value < -1.0) with a history of brittle fractures of the proximal humerus, pelvis, or distal forearm. Patients with diabetic osteoporosis: (1) meet the diagnostic criteria for osteoporosis in the 2017 edition of "Guidelines for Primary Osteoporosis Diagnosis and Treatment", that is, meet one of the following three criteria: (1) BMD of the axial bone (lumbar 1-4, femoral neck, or total hip) or the BMD of 1/3 of the distal radius by dual-energy radiography with a T value <=-2.5 (2) previous brittle fractures of the vertebra or hip (3) BMD measurements suggest low bone mass (-2.5 < T value < -1.0) with a history of brittle fractures of the proximal humerus, pelvis, or distal forearm. (2) It meets the diagnostic criteria of type 2 diabetes in the Chinese Type 2 Diabetes Prevention Guidelines (2020 Edition) formulated by the Chinese Medical Association.

Exclusion criteria

Exclusion criteria: 1. Other diseases affecting bone turnover, such as thyroid diseases, parathyroid diseases, adrenal diseases and other endocrine system diseases; Digestive and renal diseases that affect the absorption of calcium and vitamin D; Rheumatoid arthritis, systemic lupus erythematosus and other immune system diseases; Neuromuscular diseases; Diseases of the blood system; Malignant tumor; 2. Metabolic bone diseases such as rickets and Paget's disease; 3. with severe hepatic and renal insufficiency or cardiovascular and respiratory diseases; 4. Recently used drugs that affect bone turnover, such as glucocorticoids or anti-osteoporosis drugs; 5. any severe lumbar bone disorder or deformation affecting dual-energy X-ray bone mineral density measurement (DXA); 6. Serum calcium levels above 10.4 mg/dL or urinary calcium excretion above 400 mg/gCr; 7. to Aidilol ingredient allergy.

Design outcomes

Primary

MeasureTime frame
Liver and kidney function;Six electrolytes;24 hour urinary biochemistry;Procollagen I N-Terminal Propeptide;Bone specific alkaline phosphatase;ß-C-termial telopeptide of type 1 collagen;parathyroid hormone;25 hydroxyvitamin D;Density of bone;trabecular bone score;long-chain noncoding RNA NEAT1;Fasting blood glucose;Glycosylated hemoglobin;Assessment of islet function;

Countries

China

Contacts

Public ContactLi Fangping

The Seventh Affiliated Hospital of Sun Yat-sen University

472655037@qq.com13928751968

Outcome results

None listed

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