Clinical trial: G56W1 in Women With Postmenopausal Osteoporosis (NCT03720886)

Eligibility criteria:
Inclusion Criteria:

          -  Female, capable of self - motivation , 45 years old ≤ age ≤ 75 years old.

          -  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)< 25 pg/ml and follicle stimulating hormone(FSH) > 40mIU/ml should be
             met.

          -  Weight ≥ 40kg , 18 ≤ body mass index(BMI)≤ 30 .

          -  Meets one of the following diagnostic criteria for osteoporosis, and ≥ 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 density measurement
                  T- score< -1.0.

               2. The T- score of the central axis bone mineral density or the 1/3 bone density of
                  the distal radius of the tibia was ≤-2.5 measured by DXA .

               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.

          -  to participate in the trial and sign the informed consent form.

        Exclusion Criteria:

          -  to have diseases affecting calcium or bone metabolism that are not effectively
             controlled, such as primary hyperparathyroidism or hyperthyroidism, Paget's bone
             disease, hypercalcemia, hypocalcemia, active urolithiasis.

          -  Secondary osteoporosis, such as osteomalacia, rheumatoid arthritis, gout, multiple
             myeloma, etc.

          -  Severe lumbar anatomical abnormalities which affecting DXA bone mineral density
             measurement, such as severe scoliosis.

          -  Patients who have been treated for anti-osteoporosis before random enrollment:

               1. Patients who received parathyroid hormone(PTH) therapy before random enrollment
                  (including clinical trials of similar products).

               2. Patients who received bisphosphonate injection within 1 year prior to random
                  enrollment or received bisphosphonate oral administration within 3 months for > 2
                  weeks prior to enrollment.

               3. Systemic treatment of androgen, estrogen, and selective estrogen receptor
                  modulator(SERM) preparations within 3 months > 2 weeks prior to random
                  enrollment.

               4. Three months before randomized to receive of heparin, warfarin, anticonvulsants
                  (except benzodiazepines), digoxin accumulated for> 2 weeks.

               5. In the 3 months prior to random enrollment , received calcitonin, vitamin K
                  preparation, active vitamin D3 preparation, oral or intravenous glucocorticoid
                  treatment for > 4 weeks.

          -  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.

          -  Laboratory tests indicates abnormal, including any of the following indicators
             abnormalities (according to the normal range of each center, after consideration of
             the investigator with clinical considerations, such as caused by operational
             procedures, etc., after discussion with the sponsor, may allow retesting once) .

               1. Alkaline phosphatase(ALP)>1.5 times the upper limit of normal.

               2. Aspartate transaminase(AST) or alanine aminotransferase(ALT) or total
                  bilirubin(TBIL) > 2.0 times the upper limit of normal.

               3. Glycated hemoglobin(HbA1c )≥ 7.0% .

               4. White blood cell(WBC)< 3.5×10^9 /L , Hb<100g/L or Plt<90×10^9 /L.

               5. Thyroid-stimulating hormone(TSH)<0.01 mIU/L (mU/L) or TSH>10 mIU/L (mU/L) .

               6. Parathyroid hormone(PTH)>1.5 times the upper limit of normal.

               7. Serum creatinine(SCr)>1.2 times the upper limit of normal.

               8. Serum total calcium(SCa)> normal upper limit.

          -  Subjects who had significant clinical significance including HIV , hepatitis B,
             hepatitis C, and syphilis ( hepatitis B virus carriers can be enrolled ) .

          -  Heavy Smoking (average of more than 10 / day) and / or alcohol addicted (converted to
             pure alcohol 30 ml / day or more) .

          -  Recent drug abuse or drug dependence evidence.

          -  Those who are allergic to test drugs / control drugs or biological products.

          -  Included in other interventional clinical trials within 3 months of the study.

          -  Been undergone radiation therapy for bones.

          -  Mental illness or any cause of cognitive impairment.

          -  Patients who were considered unsuitable for the study based on risk benefits by
             investigators.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? 1