Intervention Study of Drugs in Patients Osteopenia and Osteoporosis

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Osteoporosis; Osteopenia, Osteoporosis

Treatments: Other: Basic treatment+ anti-osteoporosis drug group; Other: Basic treatment + non-drug treatment group; Other: Basic treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT04719572

antiosteoporosis301

Details and patient eligibility

About

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.

Full description

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

• Group1: Basic treatment group (elemental calcium 600mg/ day + vitamin D 1000IU/day)
• Group2: Basic treatment+ anti-osteoporosis drug group (alendronate, zoledronate, tripopeptide, denosumab, activated vitamin D, menatetrenone soft capsules according to the patient's condition)
• Group3: Basic treatment + non-drug treatment group(diet, exercise, rehabilitation therapy).

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities
• Postmenopausal women and male aged 50 years or old
• Osteoporosis by DXA or fragility fracture history
• Osteopenia with more than one osteoporotic risk factors

Exclusion criteria

• Secondary osteoporosis
• Renal insufficiency (Ccr< 35ml/min)
• New fractures < 3 months, prior bilateral hip fractures or surgical replacement.
• Other medication contraindications
• Malignant tumors
• Mobility-impaired individuals

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Basic treatment group

Other group

Description:

elemental calcium 600mg/ day + vitamin D 1000IU/day

Treatment:

Other: Basic treatment+ anti-osteoporosis drug group

Other: Basic treatment + non-drug treatment group

Basic treatment+ anti-osteoporosis drug group

Active Comparator group

Description:

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

Treatment:

Other: Basic treatment + non-drug treatment group

Other: Basic treatment group

Basic treatment + non-drug treatment group

Other group

Description:

diet, exercise, rehabilitation therapy

Treatment:

Other: Basic treatment+ anti-osteoporosis drug group

Other: Basic treatment group