Prevention and treatment of osteoporosis in organ transplant recipients: randomized open controlled clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001818

Enrollment

Unknown

Registered

2011-12-22

Start date

2012-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Organ transplant recipient, Osteoporosis

Interventions

1:no

2:Calcium Carbonate and Vitamin D3 Tablets

3:Calcitriol

4:Calcium Carbonate and Vitamin D3 Tablets, Calcitriol

5:Calcium Carbonate and Vitamin D3 Tablets, Calcitriol

6:Calcium Carbonate and Vitamin D3 Tablets, Calcitriol

7:Calcium Carbonate and Vitamin D3 Tablets, Calcitriol, Alendronate

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. More than 3 months after organ Transplantation; 2. Age of 20-70 years; 3. Long-term oral glucocorticoids and/or calcineurin inhibitor (FK506 or CSA); 4. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients allergic against Calcium Carbonate and Vitamin D3 Tablets, Calcitriol, Calcitonin, Alendronate and drug components accessories; 2. Patients, who use Active vitamin D in 2 months before the beginning of the study; 3. Subjects once treated with alendronate, Sr salt and sodium fluoride; 4. Suspected pregnancy or lactation; 5. Fracture in 3 months before the beginning of the study; 6. Cancer active stage; 7. Other metabolic bone disease except for osteoporosis; 8. Joint diseases seriously affect the functional tests; 9. Hyperuricemia; 10. Serum calcium level corrected>2.8 mmol/L or <2.0mmol/L; 11. Creatinine clearance rate <35 ml/min; 12. Serum alanine transaminase or total bilirubin are more than twice the normal value; 13. Undergoing physical therapy to improve muscle strength and balance; 14. Life expectancy of less than 6 months; 15. patients with delirium or dementia, who cannot obtain informed consent; 16. Recipients are participating in other clinical studies; 17. Not suitable for clinical trials because of other reasons.

Design outcomes

Primary

Measure	Time frame
bone mineral density;	—

Secondary

Measure	Time frame
Bone formation and bone resorption markers;(25-OH) D3 levels;Serum electrolytes;get-up and go test;	—

Countries

China

Contacts

Public ContactXu Chun

wjxuchun@sohu.com+86 10 57976568

Outcome results

None listed

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