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A multicenter, randomized, controlled trial for calcium and vitamin D treatment in elderly population with high fracture risk and low bone mass and establishment of reasonable intervention strategy

A multicenter, randomized, controlled trial for calcium and vitamin D treatment in elderly population with high fracture risk and low bone mass and establishment of reasonable intervention strategy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036016
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

osteopenia

Interventions

1:healthy education
2:calcium 500mg, vitamin D 2000 IU

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Women over 65 years old, men over 70 years old; 2. Bone mineral density of lumbar spine (L1-4) or femoral neck or total hip showed that T value -2.5 to -1.0; 3. The subjects personally signed the informed consent form, indicating that they have been fully informed of the relevant contents of the research; 4. Subjects are willing and able to follow the research visit arrangements.

Exclusion criteria

Exclusion criteria: 1. any diseases known to affect bone metabolism or calcium metabolism, such as bone embolic diseases including osteomalacia, osteogenesis imperfecta and paget disease of bone; cushing syndrome; acromegaly;Parathyroid Diseases;thyroid disease;Malabsorption syndrome or any gastrointestinal diseases associated with malabsorption; abnormal calcium levels; rheumatoid arthritis; 2. Malignant tumor history in recent 5 years; 3. any medication history of anti-osteoporosis or known to affect bone metabolism, such as Bisphosphonate, Teripapeptide, selective estrogen receptor modulator; active vitamin D metabolites; glucocorticoid and the analogues; 4. medication history of Psychoactive drugs, substance abusers and dependents; 5. allergic history to the medication used in the study; 6. osteoporotic fractures history of distal forearm, hip, proximal humerus, vertebral, or X-ray examination inactive of vertebral fracture; 7. participation in other clinical studies within the first 3 months of subjects screening; 8. any other acute or chronic disorders not suitable for this study

Design outcomes

Primary

MeasureTime frame
osteoportic fracture;

Secondary

MeasureTime frame
bone mineral density;bone turnover marker;

Countries

China

Contacts

Public ContactZhen-Lin Zhang

Shanghai Sixth People's Hospital

zhangzl@sjtu.edu.cn+86 13621673716

Outcome results

None listed

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