postmenopausal osteoporosis
Conditions
Interventions
Low dose group:Take 1 (56.5 µg) of recombinant human parathyroid hormone for injection (56.5 µg) dissolved in 2 ml of water for injection, and take 1 ml of subcutaneous injection once a week.
High dose group:Take 1 (56.5 µg) of recombinant human parathyroid hormone for injection (56.5 µg) dissolved in 1 ml of water for injection, 1 ml subcutaneously, 1 time/week
Control group:Take 1 capsule of Teribone (Teriparatide for injection) dissolved in 1 ml of normal saline, 1 ml subcutaneously, 1 time/week
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, with the ability to move independently, aged 45 to 75 years old; 2. Natural menopause for 3 years or more; or surgical menopause for 3 years or more (surgery needs to be performed after 40 years old), for women with surgical menopause, estradiol (E2) 40 mIU/ml; 3. Weight >=40kg, body mass index (BMI) 18 to 30; 4. It meets one of the following diagnostic criteria for osteoporosis, and at least 3 vertebral bodies of L1-4 can be measured by bone mineral density using the DXA method; (1) brittle fracture of the hip or vertebral body, and the bone measured density measurement T-value <-1.0; (2) The T-value of the central axis bone mineral density measured by DXA or the 1/3 bone density of the distal radius of the tibia is <=-2.5; (3) Bone density measurements were consistent with low bone mass (-2.5<T-value <-1.0) and combined with proximal humerus, pelvic or forearm distal brittle fractures; 5. Volunteer to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known diseases that affect calcium or bone metabolism, such as primary hyperparathyroidism or hyperthyroidism, Paget's bone disease, hypercalcemia, hypocalcemia, active urine that are not effectively controlled Stone disease 2. Patients with secondary osteoporosis, such as osteomalacia, rheumatoid arthritis, gout, multiple myeloma, etc.; 3. Abnormal lumbar anatomical abnormalities affecting DXA bone mineral density measurement, such as severe scoliosis; 4. Patients who have been treated for anti-osteoporosis before random enrollment are as follows: (1) Patients who have received PTH treatment before random enrollment (including clinical trials of similar products); (2) Patients who received bisphosphonate injection for injection within 1 year prior to random enrollment or received bisphosphonate oral administration within 3 months prior to enrollment for > 2 weeks; (3) Total systemic treatment of androgen, estrogen, and SERM preparations within 3 months prior to random enrollment > 2 weeks; (4) Heparin, warfarin, anticonvulsant drugs (except benzodiazepines), and digoxin treatment for >2 weeks before random enrollment; (5) The cumulative intake of calcitonin, vitamin K preparation, active vitamin D3 preparation, oral or intravenous glucocorticoid treatment within 3 months prior to random enrollment; 5. suffering from severe kidney disease, uncontrolled high blood pressure (>=150/100 mmHg), symptomatic ischemic heart disease, cerebral infarction or obliterative atherosclerosis, malignancy, and other serious underlying diseases; 6. Laboratory indicators found abnormal indicators, including any of the following indicators abnormalities (calculated according to the normal range of each center, such as the researcher combined with clinical considerations caused by operational procedures, etc., after discussion with the sponsor, may allow retesting once): (1) ALP > 1.5 times the upper limit of normal; (2) AST or ALT or TBIL > 2.0 times the upper limit of normal; (3) HbA1c >=7.0%; (4) WBC10 mIU/L (mU/L); (6) PTH > 1.5 times the upper limit of normal; (7) SCr>1.2 times the upper limit of normal; (8) SCa> normal upper limit. 7. Subjects who have clinically significant abnormalities including HIV, hepatitis B, hepatitis C, and syphilis (hepatitis B virus carriers can be enrolled); 8. Those who are addicted to smoke (average 10/day or more) or/and alcoholism (converted to pure alcohol 30 ml/day or more); 9. Those who have recent drug abuse or drug dependence evidence; 10. Those who are allergic to test drugs/control drugs and biological products; 11. Those who have received other interventional clinical studies within the first 3 months of the study; 12. Patients who have undergone radiation therapy for bones; 13. mental illness or any cause of cognitive impairment; 14. The investigator considers patients who are considered unsuitable for this study based on risk benefits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of change in bone density of the lumbar spine (L1-4) from baseline after 24 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the rate of change of PINP, s-CTX, BALP, and blood calcium from baseline;Evaluation of the rate of change of total hip bone density from baseline after 24 weeks of G56W1 treatment; | — |
Countries
China
Contacts
Public ContactLu Chunyan
West China Hospital, Sichuan University
Outcome results
None listed