pramary osteoporosis
Conditions
Interventions
test group:Caltrate D600 Tablets+rhPTH(1-34)
control group:Caltrate D600 Tablets+Elcatonin
Sponsors
Tongji Hospital of Tongji
Eligibility
Sex/Gender
All
Age
50 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Primary osteoporosis diagnosed by medical history, clinical manifestation, physical signs; 2. male or female; 3. female aged 50-79 and post-menopause for more than 3 years, male aged 60-79; 4. inpatient or outpatient who is taken with care; 5. volunteerly signed informed consent form
Exclusion criteria
Exclusion criteria: 1. Any osteopathia or metabolic bone disease other than primary osteoporosis; 2. diabetes patients with HbA1C>7% or with severe acute or chronic complication, other severe endocrine diseases; 3. Liver disfunction, renal disfunction (ALT>2.0N, Cr>1N, no criteria of AST and BUN), active hepatitis; 4. severe heart disease, hematologic disease, psychiatric or neurological disease; 5. cancer or other severe progressive disease; 6. Receiving phosphates therapy in the previous 6 months; receiving drugs affecting bone metabolism in the previous month (not including calcium or VitD); 7. hypersensitivity to investigational product, placebo or any metabolin of the product; 8. allergic constitution or allergic to multiple medications; 9. participating in another clinical trial within the previous three months; 10. poor compliance to complete the trial; 11. inappropriate to participate by investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of bone mineral density;bone-specific alkaline phosphatase (BSAP); | — |
Secondary
| Measure | Time frame |
|---|---|
| changesof rational symptom;decrease bone fracture;Urinary calcium;Serum calcium;before and after self compare of rhPTH(1-34);Changes of CTX;Serum phosphorum; | — |
Countries
China
Contacts
Public ContactXiuzhen Zhang
Outcome results
None listed