Intervention Study of Drugs in Patients Osteopenia and Osteoporosis

Osteoporosis Clinical Trial

Official title:

Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04719572
• Other study ID #: antiosteoporosis301
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: January 2023

Study information

• Verified date: January 2021
• Source: Chinese PLA General Hospital
• Contact: Chunlin Li, M.D&Ph.D
• Phone: +86-13810921655
• Email: lichunlin301[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: January 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia, Osteoporosis
• Osteoporosis

Intervention

Other:
• Basic treatment group
A total of 60 subjects were recruited in the group.
• Basic treatment+ anti-osteoporosis drug group
A total of 60 subjects were recruited in the group.
• Basic treatment + non-drug treatment group
A total of 60 subjects were recruited in the group.

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Aerospace General Hospital, Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy on BTMs level	The change of BTMs level after different interventions	3 months?6months?9months?12months
Primary	The efficacy on BDM level	The change of BDM level after different interventions	12 months
Secondary	Fracture rate	Fracture rate during follow up	12 months
Secondary	The type and rate of drug adverse reactions	The type and rate of drug adverse reactions during follow up	12 months