Clinical trial NCT04719572: Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
Official title: Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Osteopenia, Osteoporosis
Keywords: Anti-osteoporosis therapy
men
Postmenopausal women
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Jishuitan Hospital
name: Beijing Aerospace General Hospital
First posted: 2021-01-22
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy on BTMs level
timeFrame: 3 months、6months、9months、12months
measure: The efficacy on BDM level
timeFrame: 12 months
Secondary outcomes:
measure: Fracture rate
timeFrame: 12 months
measure: The type and rate of drug adverse reactions
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
Study officials:
affiliation: PLA General Hospital
name: Chunlin Li, M.D&Ph.D
role: PRINCIPAL_INVESTIGATOR
References: