Osteoporosis and sarcopenia
Conditions
Interventions
Dmab Group:Denosumab, Amgen Company, registered trade name of Prolide in Chinese Mainland, injection, 60mg/piece, 60mg q6m SC
Basic drugs (both the test group and the control group): calcium carbonate D3 tablet, Wyeth Pharmaceutical Co., Ltd., registered trade name of calci D in Chinese Mainland, tablet, containing 1.5g calc
Control Group:Alendronate Sodium Tablets, MSD (China) Co., Ltd., registered in Chinese Mainland under the trade name of Fushanmei, tablet, containing 70mg of Alendronate Sodium Tablets, 70mg qw po.
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Subjects who understand the purpose and experimental procedures of this study, are willing to comply with the research protocol, and voluntarily sign an informed consent form during the study; (2) Postmenopausal women: without the influence of any medication or treatment, there has been no spontaneous vaginal bleeding or dripping for more than 12 consecutive months before screening; (3) 55 to 75 years old (including 55 and 75 years old); (4) Osteoporosis: Based on DXA (spine/hip joint -4.0 20% (spine) or>3% (hip) (5) Meets the AWGS 2019 diagnostic criteria for sarcopenia or possible sarcopenia: low muscle strength (hand grip strength0.43 ng/mL; 4) Low body weight [Body mass index (BMI) = 19 kg/m2] 5) Advanced age (= 70 years old); 6) Current smokers.
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria cannot be selected for this study: (1) It is known that dinomumab or alendronic acid or other drug excipients are allergic or intolerant; (2) Patients who have received treatment with bisphosphate or desucumab within the past 6 months (which may affect enrollment) (3) Unable to sit or stand for at least 30 minutes (4) Long term use of corticosteroids (5) Abnormal or delayed esophageal/gastric emptying in the esophagus (6) Hypocalcemia (7) History of tooth extraction and jawbone necrosis within 6 months (8) Malignant tumor patients; Severe liver disease; Severe heart disease (9) Renal failure (estimated glomerular filtration rate<30 mL/min) (10) Mental illness or inability to understand or fill out questionnaires in affected limbs, as well as other comorbidities known to affect muscle mass and strength (malabsorption syndrome, Parkinson's disease, physical disability) (11) Inability or unwillingness to provide informed consent, failure to comply with the possibility of treatment allocation or research protocol (12) Other reasons why researchers believe subjects are not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DXA()BMD&ASMI); | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI;grip;SarQoL;SPPB;Equal length force test;ODI;X-ray; | — |
Countries
China
Contacts
Public ContactZhao Jie
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed