osteoporosis
Conditions
Interventions
Control group:intravenous bisphosphonate + oral placebo
Experiment group 1:intravenous bisphosphonate + oral HMB (ß-hydroxy-ß-methylbutyrate)
Experiment group 2:intravenous bisphosphonate + exercise prescription
Experiment group 3:intravenous bisphosphonate + exercise prescription +oral HMB
Sponsors
Tianjin Hospital
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Male or female patients between the ages of 55-75, of which women need to be menopausal for more than 1 year; 3. Body mass index (BMI) between 18.5-30.0 kg/m2; 4. Meet the WHO recommended diagnostic criteria for osteoporosis: determination of bone density based on DXA, lumbar spine L1-L4, femoral neck or total hip T value= -2.5SD.
Exclusion criteria
Exclusion criteria: 1. Secondary osteoporosis; 2. There are conditions that affect bone density measurement, such as less than 3 lumbar spine in L1-L4 can be measured; 3. Patients with diseases that affect bone metabolism, such as Paut's bone disease, active kidney stones, and osteomalacia; 4. Endocrine diseases, such as gonadal, adrenal glands, primary parathyroid dysfunction and poorly controlled hyperthyroidism or hypothyroidism; 5. Those with serious primary diseases, such as severe cardiopulmonary diseases, malignant tumors and psychiatric diseases; 6. Abnormal liver and kidney function (serum alkaline phosphatase> 1.5 times normal value; creatinine clearance < 30 mL/min); 7. Abnormal blood calcium (serum calcium = 2.0mmol/L or = 2.75mmol/L); 8. Those who are allergic to research-related drugs (calcium, vitamin D, HMB dietary supplements and bisphosphonates); 9. Those who have used the following drugs before enrollment: those who have taken bisphosphonate drugs orally for more than 3 months within 1 year or have taken them for more than 1 year in total; Intravenous bisphosphonate treatment within 2 years; Those who have received other anti-osteoporotic drugs within 1 year; Oral or intravenous corticosteroid therapy within 1 year; 10. Those who are participating in other clinical investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar bone density test;Hip bone density test; | — |
Secondary
| Measure | Time frame |
|---|---|
| pain scale; | — |
Countries
China
Contacts
Public ContactXinlong Ma
Tianjin hospital
Outcome results
None listed