Status:
NOT_YET_RECRUITING
Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis
Lead Sponsor:
Peking University Third Hospital
Conditions:
Circadian Rhythm Disorders
Osteoporosis
Eligibility:
FEMALE
60-70 years
Phase:
NA
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...
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 approve...
Eligibility Criteria
Inclusion
- Aged 60-70 years (inclusive).
- Naturally postmenopausal women with≥5 years since last menses.
- DXA-measured BMD T-score≤-3.0 at lumbar spine (L1-L4) and/or total hip at screening.
- 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.
- Normal-range serum parameters:
- Intact PTH: 15-65 pg/mL Total calcium: 2.20-2.70 mmol/L.
Exclusion
- Subjects with bone metabolic diseases besides osteoporosis:
- Other metabolic bone diseases, such as osteomalacia, osteogenesis imperfecta, Paget's disease；
- Cushing's syndrome;
- Hyperprolactinemia;
- Use of medications that affect bone metabolism before screening:
- Use of intravenous bisphosphonates, fluoride, or strontium within 2 years; Use of teriparatide or denosumab for osteoporosis within 6 months; Oral bisphosphonates for osteoporosis with the last dose within 1 year (if used within 1 year but with a cumulative use of ≤1 month, the subject is eligible); Continuous use of calcitonin for more than 3 months with the last dose within 1 year.
- History of malignancy within 5 years, or bone metastasis, except for tumors that are expected to be cured after treatment (such as completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or breast ductal carcinoma, etc.).
- Hypocalcemia and hypercalcemia.
- Elevated alkaline phosphatase of unknown cause.
- History of fractures.
- Uncontrolled comorbidities, including heart failure with New York Heart Association (NYHA) functional class III or above, glycated hemoglobin \>8.5%, and severe arrhythmias.
- Allergy to teriparatide.
- Currently participating in another drug clinical trial.
- Subjects deemed unsuitable for enrollment in this study by the investigator.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06951776
Start Date
May 1 2025
End Date
December 30 2025
Last Update
April 30 2025
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