Osteoporosis
Conditions
Interventions
Control group:Sham green light irradiation + denosumab (60mg/ time, subcutaneous injection every 6 months) + calcium (600 mg/d) + vitamin D (800 IU/d)
Intervention group:On the basis of the control group, green light irradiation (520±10nm, 400 lux, 120 minutes per day, 6 months) was added.
Sponsors
Shanghai Yangzhi Rehabilitation Hospital (Sunshine Rehabilitation Center)
Eligibility
Sex/Gender
Female
Age
50 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1.Menopause duration of >=1 year; 2.Age 50–74 years; 3.Women who meet the diagnostic criteria for osteoporosis, with a bone mineral density T-score =30 ng/mL, and normal serum calcium and phosphorus levels; 4.Non-night shift workers with a regular daily routine who can ensure receiving light exposure at a fixed time each day during the intervention period; 5.Able to cooperate with the study procedures, sign the informed consent form, and have good compliance; 6.Not planning to relocate or take long-term travel during the intervention period, and able to complete the 6-month follow-up as required;
Exclusion criteria
Exclusion criteria: 1.Having diseases that may affect bone metabolism, such as active malignant tumors, hyperthyroidism, chronic hepatitis/nephritis, etc; 2.Severe renal insufficiency, eGFR < 30 ml/min; 3.Having osteonecrosis of the jaw, or severe periodontal disease requiring treatment within the past 3 months; 4.Hypocalcemia; 5.Use of other anti-osteoporosis medications within 1 year except for vitamin D and calcium supplements, especially bisphosphonates or denosumab; 6.Use of any type of hormones within the past 3 months; 7.Those who are allergic to the active ingredient or any excipients; 8.Having visual impairments, including color blindness, color weakness, retinal diseases, or other conditions that are unsuitable for receiving light intervention, as well as active ophthalmic diseases;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone formation marker (PINP);Bone resorption index (ß-CTX); | — |
Secondary
| Measure | Time frame |
|---|---|
| 25-OH vitamin D;Pituitary-gonadal axis hormone levels (gonadotropin inhibitory hormone GnIH, luteinizing hormone, follicle stimulating hormone, estradiol, testosterone, etc.);Bone mineral density; | — |
Countries
China
Contacts
Public ContactLan Wu; Chao Zhang
Shanghai Yangzhi Rehabilitation Hospital (Sunshine Rehabilitation Center)
Outcome results
None listed