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Correlating oxidative stress-related factors with bone metabolic markers in male elderly patients with degenerative osteoporosis living in the high-altitude hypoxic region of China: study protocol for a non-randomized controlled trial

Correlating oxidative stress-related factors with bone metabolic markers in male elderly patients with degenerative osteoporosis living in the high-altitude hypoxic region of China

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ROC-17012848
Enrollment
Unknown
Registered
2017-09-30
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degenerative osteoporosis

Interventions

1:Elderly patients with degenerative osteoporosis from a high-altitude area
2:Healthy elderly controls

Sponsors

Affiliated Hospital of Qinghai University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria of osteoporosis group: 1. Loading pain; 2. Aged 60-70 years; 3. Male patients; 4. Unbearable spontaneous low back pain; 5. Able to sit up, turn his/her body over, and walk with bearable pains; 6. Unable to sleep because of pains. Inclusion criteria of control group: 1. Male healthy elderly people who have lived in high-altitude hypoxic environment for over 10 years; 2. Good compliance.

Exclusion criteria

Exclusion criteria: Exclusion criteria of osteoporosis group: Patients presenting with one or more of the following criteria are rejected for this study: 1. Presence of vertebral compression fracture on X-ray film; 2. Definitive diagnosis of rheumatoid arthritis, osteomalacia, hyperthyroidism, hyperparathyroidism, or other bone metabolic diseases; 3. During external fixation with gypsum for repair of fracture or within 6 months after removal of gypsum 4. With pain-inducing diseases such as lumbar disc herniation, deformed vertebral arthritis, lumbar spinal stenosis, vertebral spondylolisthesis, and ankylosing spondylitis; 5. Unable to judge for curative effects, provide disease condition, or unable to cooperate with treatment because of mental illness, senile dementia or severe neurosis; 6. No daily life self-care ability or long-term bed rest; continuous administration of activated vitamin D preparations, calcitonin, corticosteroid hormone, androgen, estrogen or other hormonal preparations within 3 months prior to participation in this trial; 7. Administration of selective estrogen receptor modulator within 6 months prior to participation in this trial; 8. With severe kidney, liver disease or have a history of cancer. Exclusion criteria of control group: 1. Hyperthyroidism, hypoparathyroidism or other bone metabolic diseases; 2. Diabetes mellitus; 3. Kidney or liver diseases.

Design outcomes

Primary

MeasureTime frame
HIF-1a level;

Secondary

MeasureTime frame
HIF-2a level;VEGF level;Osteocalcin level;TRACP 5b level;Correlation between serum levels of oxidative stress indicators (HIF-1a, HIF-2a and VEGF) and serum levels of bone metabolic markers (osteocalcin and TRACP 5b);

Countries

China

Contacts

Public ContactDechun Li

Affiliated Hospital of Qinghai University

jianwwmm@163.com+86 18909715055

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026