Circadian Rhythm Disorders, Osteoporosis
Conditions
Keywords
Teriparatide, osteoporosis, Chronotherapy
Brief summary
This is a randomized, controlled, and exploratory study designed to evaluate the chronotherapeutic effects of teriparatide administration in postmenopausal osteoporosis. Twenty-eight participants (age 60-70 years, lumbar spine T-score ≤-3.0) will undergo 1:1 randomization to receive 20 µg/day teriparatide subcutaneously at either 08:00 or 20:00 for 12 weeks. Standardized supplementation with calcium (1,000-1,500 mg/day) and cholecalciferol (800-1,200 IU/day) will be maintained. Primary endpoints are between-group differences in serum CTX and P1NP profiles, quantified at baseline, 4-week interim, and 12-week endpoint. The secondary outcomes will assess safety during the trial.
Detailed description
This is a randomized, controlled, and exploratory study designed to evaluate the chronotherapeutic effects of teriparatide administration in postmenopausal osteoporosis. The trial protocol was approved by the Peking University Third Hospital Medical Science Research Ethics Committee. This trial intends to enroll postmenopausal osteoporosis patients admitted to the Department of Orthopedics of Peking University Third Hospital. Subjects who meet the inclusion and exclusion criteria can be enrolled in this trial after signing the informed consent form. Each trial group plans to enroll 14 subjects, with a total of 28 subjects. Eligible participants will be randomly assigned (1:1) to either subcutaneous injection of 20 μg teriparatide at 08:00 a.m in the morning (Group A) and subcutaneous injection of 20 μg teriparatide at 20:00 p.m in the evening(Group B). The specific time of drug administration for each patient every day needs to be recorded in the diary card. All subjects will be given calcium (1000-1500 mg/day) and vitamin D (800-1200 IU/day) simultaneously during the trial.
Interventions
BEHAVIORALMorning administration group of teriparatide
Eligible participants will be randomly assigned (1:1) to either subcutaneous injection of 20 μg teriparatide at 08:00 a.m. in the morning (Group A) and subcutaneous injection of 20 μg teriparatide at 20:00 p.m. in the evening (Group B).
BEHAVIORALEvening administration group of teriparatide
Eligible participants will be randomly assigned (1:1) to either subcutaneous injection of 20 μg teriparatide at 08:00 a.m. in the morning (Group A) and subcutaneous injection of 20 μg teriparatide at 20:00 p.m. in the evening (Group B).
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Twenty-eight participants (age 60-70 years, lumbar spine T-score ≤-3.0) will undergo 1:1 randomization to receive 20 µg/day teriparatide subcutaneously at either 08:00 or 20:00 for 12 weeks. Standardized supplementation with calcium (1,000-1,500 mg/day) and cholecalciferol (800-1,200 IU/day) will be maintained. Primary endpoints are between-group differences in serum CTX and P1NP profiles, quantified at baseline, 4-week interim, and 12-week endpoint. The secondary outcomes will assess safety during the trial.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 60-70 years (inclusive). 2. Naturally postmenopausal women with≥5 years since last menses. 3. DXA-measured BMD T-score≤-3.0 at lumbar spine (L1-L4) and/or total hip at screening. 4. The concentration of 25-hydroxyvitamin D (25-OH)D is ≥20 ng/ml. If the subject meets all other inclusion and
Exclusion criteria
, it is allowed to retest the 25-OHD concentration after administering vitamin D to the subject. 5. Normal-range serum parameters: Intact PTH: 15-65 pg/mL Total calcium: 2.20-2.70 mmol/L.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of PTH from baseline after administration | Within 12 weeks | Compare the morning and evening dosing groups regarding the changes in serum PTH from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide. |
| Change of P1NP from baseline after administration | Within 12 weeks | Compare the morning and evening dosing groups regarding the changes in serum P1NP from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide. |
| Change of CTX from baseline after administration | Within 12 weeks | Compare the morning and evening dosing groups regarding the changes in serum CTX from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | Within 12 weeks | All adverse drug reactions that occurred during the trial. |
Contacts
Primary ContactHuan Wang, Dr
Outcome results
None listed