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| Name | Class |
|---|---|
| Beijing Jishuitan Hospital | OTHER |
| Beijing Aerospace General Hospital | OTHER |
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This is a 12 months, randomized, multicenter, open-label, parallel-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies.
This is a 12 months,randomized, multicenter, open-label, pragmatic-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies, including
Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. About 180 postmenopausal women and elderly male with osteoporosis or osteopenia will be included in this study.
All subjects will be given informed consent before starting any examination and test. The following data of all subject will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D, bone turnover markers(BTMs) (inculding serum procollagen type I N-propeptide, serum C-terminal telopeptide of type I collagen,osteocalcin and alkaline phosphatase), thoracic and lumbar spine X-ray, bone mineral density(BMD) by dual energy X-ray.
Then they will be randomized into three groups at a 1:1 ratio. Every group will be given calcium carbonate and vitamin D. In the group 2, the medication will be decided by the doctor according to the patients' condition. Particularly, denosumab has not been approved for male adaptation, we will sign an additional informed consent.
All subjects will be followed by visiting clinic every three months and complete the examinations to assess the safety and efficacy. Safety indexes: liver and kidney function, urine routine test and 24-h urine calcium. Efficacy indexes: BMD change, BTMs changes and fracture reduction. All subjects will be followed 12 months and data will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic treatment group | Other | elemental calcium 600mg/ day + vitamin D 1000IU/day |
|
| Basic treatment+ anti-osteoporosis drug group | Active Comparator | alendronate(70mg/week), zoledronate(5mg 1/ year), tripopeptide(20ug 1/day), denosumab(120mg/month), activated vitamin D(0.25ug 1/day), menatetrenone(15mg tid) according to the patient's condition |
|
| Basic treatment + non-drug treatment group | Other | diet, exercise, rehabilitation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basic treatment group | Other | A total of 60 subjects were recruited in the group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy on BTMs level | The change of BTMs level after different interventions | 3 months、6months、9months、12months |
| The efficacy on BDM level | The change of BDM level after different interventions | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture rate | Fracture rate during follow up | 12 months |
| The type and rate of drug adverse reactions | The type and rate of drug adverse reactions during follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlin Li, M.D&Ph.D | Contact | +86-13810921655 | lichunlin301@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunlin Li, M.D&Ph.D | PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Basic treatment+ anti-osteoporosis drug group | Other | A total of 60 subjects were recruited in the group. |
|
| Basic treatment + non-drug treatment group | Other | A total of 60 subjects were recruited in the group. |
|
| 12 months |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |