Intervention Study of Drugs in Patients Osteopenia and Osteoporosis

Not Applicable

• Conditions: Osteoporosis; Osteopenia, Osteoporosis
• Interventions: Other: Basic treatment+ anti-osteoporosis drug group; Other: Basic treatment group; Other: Basic treatment + non-drug treatment group

• Registration Number: NCT04719572
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-21
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-25
• Study Start: 2021-03
• Primary Completion: 2022-09
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basic treatment group	Basic treatment+ anti-osteoporosis drug group	elemental calcium 600mg/ day + vitamin D 1000IU/day
Basic treatment+ anti-osteoporosis drug group	Basic treatment group	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	Basic treatment group	diet, exercise, rehabilitation therapy
Basic treatment group	Basic treatment + non-drug treatment group	elemental calcium 600mg/ day + vitamin D 1000IU/day
Basic treatment + non-drug treatment group	Basic treatment+ anti-osteoporosis drug group	diet, exercise, rehabilitation therapy
Basic treatment+ anti-osteoporosis drug group	Basic treatment + non-drug treatment group	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

Primary Outcome Measures

Name	Time	Method
The efficacy on BDM level	12 months	The change of BDM level after different interventions
The efficacy on BTMs level	3 months、6months、9months、12months	The change of BTMs level after different interventions

Secondary Outcome Measures

Name	Time	Method
The type and rate of drug adverse reactions	12 months	The type and rate of drug adverse reactions during follow up
Fracture rate	12 months	Fracture rate during follow up

Trial Locations

Locations (1)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China