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Therapeutic effect of combined aldosterone receptor antagonist on postmenopausal osteoporosis

Therapeutic effect of combined aldosterone receptor antagonist on postmenopausal osteoporosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061781
Enrollment
Unknown
Registered
2022-07-02
Start date
2022-06-20
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

postmenopausal osteoporosis

Interventions

Intervention group:Calcium intake was 1200mg(elemental calcium)/ day, calcitriol 0.25ug/ day, alendronate 70mg/ week, spironolactone 40mg/ day (orally divided twice). Patients with poor blood pressure
Control group:Calcium intake was 1200mg(elemental calcium)/ day, calcitriol 0.25ug/ day, alendronate 70mg/ week and CCB antihypertensive drugs were given to control blood pressure

Sponsors

Beijing Luhe Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. To confirm the diagnosis of PMOP, the diagnostic criteria refer to the primary osteoporosis Diagnosis and Treatment Guidelines written by osteoporosis and Bone Mineral Salt Diseases Branch of Chinese Medical Association (2017). Bone mineral density of the central axis (lumbar 1-4, femoral neck or whole hip) or distal radius based on DXA measurements in postmenopausal women within 5-10 years. The diagnostic criteria for osteoporosis is t-score <= -2.5; 2. Clear history of hypertension (note: patients with spironolactone indication); 3. Female, aged 50-75; 4. Agree and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Definite diagnosis of primary aldosteronism; 2. secondary osteoporosis, including the influence of bone metabolic endocrine disease (parathyroid disease, gonad disease, adrenal disease, and thyroid disease, etc.), autoimmune diseases such as rheumatoid arthritis, and affecting the metabolism of calcium and vitamin absorption and digestive and kidney diseases, neuromuscular disease, malignant diseases such as multiple myeloma, A variety of congenital and acquired abnormal bone metabolism diseases, long-term use of glucocorticoids or other drugs affecting bone metabolism; 3. those with a life expectancy of less than 3 years; 4. Patients with serious heart, brain, liver and kidney diseases, tumors and kidney stones.

Design outcomes

Primary

MeasureTime frame
dual energy X-ray absorptiometry;

Secondary

MeasureTime frame
ß-Collagen C-Telopeptide-x;Total Procollagen I N-Terminal Propeptide;glomerular filtration rate;serum potassium;

Countries

China

Contacts

Public ContactNannan Wu

Beijing Luhe Hospital, Capital Medical University

15010076018@163.om+86 15010076018

Outcome results

None listed

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