Early osteonecrosis of the femoral head with osteoporosis
Conditions
Interventions
Test group:Alendronate and Vitamin D3 Tablets (GuBangjia) (70 mg ALN + 2800 IU Vitamin D3/tablet) once a week, one pill for each time, with an interval of at least 3 days between doses, for 12 months
Control group:Placebo once a week, one pill for each time, with an interval of at least 3 days between doses, combined with conventional treatment regimen for 12 months
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, male or female; 2. Osteonecrosis of the femoral head was diagnosed by anteroposterior and lateral X-ray of the hip, CT of both hips, and MRI of both hips, and the dual-energy X-ray bone mineral density was less than -1.5 in patients with osteoporosis or osteopenia at stages I-II of the International Society of Bone Circulation (ARCO) staging; 3. No systemic or local infection; 4. Agree to take effective contraceptive measures during the trial until the last follow-up, and women of childbearing age have a negative pregnancy test before the start of dosing; 5. Voluntarily participate in this clinical study and sign a written informed consent form. If the patient himself/herself cannot obtain informed consent, he/she may authorize to give his/her legal representative.
Exclusion criteria
Exclusion criteria: 1.Known history of HIV, or active hepatitis B or active hepatitis C; 2.Drug addiction (including drug, anesthetic and alcohol addiction); 3.Pregnant and lactating women, or planning to become pregnant within 2 years after initial registration; 4.Participation in another clinical study or simultaneous participation in another clinical trial within 3 months before enrollment; 5.Skeletally immature; 6.Septic arthritis, stress fracture, or non-osteonecrotic metabolic bone disease (such as Paget's disease, osteogenesis imperfecta, primary hyperparathyroidism, osteosclerosis, and fibrous dysplasia including mono, polyposis, and McCune-Albright syndrome); 7.Skin infection during surgery; 8.Active local bone infection; 9.Lumbar radiculopathy and/or neurogenic or vascular claudication; 10.Patients with severe liver and kidney dysfunction; (1) ALT or AST > 1.5 times of the upper limit of normal; (2) Cr > upper limit of normal; 11.Patients with poorly controlled diabetes (HbA1c >= 8%), peripheral neuropathy, or serious vascular problems; 12.Patients with metabolic diseases (gout and rheumatism, etc.); 13.Disease or drug related coagulation disorders; 14.Patients with malignant tumor; 15.Patients receiving hematopoietic growth factors or anti-angiogenic or anti-angiogenic therapy (such as anti-vascular endothelial growth factor); 16.Patients with other serious systemic diseases and psychosis; 17.Patients with other conditions that investigators think not suitable for participating in this clinical.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall contour of the femoral head, the volume of the osteonecrosis area and the changes in the blood supply of the femoral head, changes in bone density;Incidence of severe adverse reactions within 12 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of hip joint function;Evaluation of activities of daily living ;Evaluation of pain;Global health status and changes in quality of life; | — |
Countries
China
Contacts
Public ContactPeng Jiang
Chinese People's Liberation Army General Hospital
Outcome results
None listed