Therapeutic effects of osteoporotic patients treated with Teribone in patients with hip fracture
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0003852
- Lead Sponsor
- Gyeongsang National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 104
Non-probabilistic extraction
1) Patients scheduled for surgery or underwent surgery due to hip fracture
- Hip fractures include femoral neck, phalangeal fractures, and sub-electronic fractures.
2) Hip arthroplasty methods include bipolar artificial joint replacement, total hip arthroplasty, open reduction, and internal fixation.
3) Patients with osteoporosis and osteopenia (T-score: -2.0 or less in bone mineral density test)
4) randomized double blind with 52 subjects in the experimental group and 52 subjects in the control group.
1) Pregnant women / lactating women (subjects with potential pregnancy should use appropriate methods of contraception (oral, physeal, mechanical, and surgical contraceptive methods)
2) patients with decreased renal function (creatinine clearance <35.0 mL / min), bone marrow diseases and malignant tumors (multiple myeloma, metastatic tumors, hemolytic anemia, leukemia, lymphoma)
3) hypocalcemia (serum calcium concentration less than 8 mg / dL or 2.0 mmol / L)
4) Patients who are sensitive to severe heart disease and PTH agents
5) Patients already taking other PTH preparations
6) Patients who should be excluded by judgment from researchers due to other medical and psychological problems
7) Patient who can not trust patient's cooperation
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in bone density
- Secondary Outcome Measures
Name Time Method Activity level, walking time, KOVAL, blood test, Radiologically callus formation within 12 months CT, Dexa, x-ray